2015_cancer_drug_list.pdf

8/18/2019 2015_cancer_drug_list.pdf

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2015 Medicines in Development for Cancer

Bladder Cancer

Product Name Sponsor Indication Development Phase

ABI-009 AADi non-muscle invasive bladder cancer Phase I/II

(nanoparticle albumin-bound Pacific Palisades, CAmTOR inhibitor)

ACP-196 Acerta Pharma platinum-refractory bladder cancer Phase II(Btk inhibitor) San Carlos, CA (combination therapy) www.acerta-pharma.com

(see also head/neck, hematological, leukemia,

lung, lymphoma, myeloma, pancreatic)

ALT-801 Altor BioScience advanced bladder cancer, Phase II(immunotherapy fusion protein) Miramar, FL non-muscle invasive bladder cancer www.altorbioscience.com

ALT-803 Altor BioScience non-muscle invasive bladder cancer Phase I/II(IL-15 superagonist complex) Miramar, FL (see also hematological, myeloma, skin) www.altorbioscience.com

apatorsen OncoGenex Pharmaceuticals metastatic bladder cancer Phase II(Hsp27 inhibitor) Bothell, WA (see also lung, pancreatic, prostate) www.oncogenex.com

apaziquone Spectrum Pharmaceuticals non-muscle invasive bladder cancer Phase III(DNA synthesis inhibitor) Henderson, NV (Fast Track) www.sppirx.com

ASG-15ME Agensys relapsed bladder cancer Phase I(antibody drug conjugate) Santa Monica, CA www.agensys.com

Seattle Genetics www.seattlegenetics.comBothell, WA

B-701 BioClin Therapeutics metastatic bladder cancer (2nd-line) Phase II(anti-FGFR3 mAb) San Ramon, CA www.bioclintherapeutics.com

BC-819 BioCancell Therapeutics bladder cancer (2nd-line) Phase II(gene therapy) Jerusalem, Israel (see also pancreatic) www.biocancell.com

http://www.acerta-pharma.com/http://www.altorbioscience.com/http://www.altorbioscience.com/http://www.oncogenex.com/http://www.sppirx.com/http://www.agensys.com/http://www.seattlegenetics.com/http://www.bioclintherapeutics.com/http://www.biocancell.com/http://www.biocancell.com/http://www.bioclintherapeutics.com/http://www.seattlegenetics.com/http://www.agensys.com/http://www.sppirx.com/http://www.oncogenex.com/http://www.altorbioscience.com/http://www.altorbioscience.com/http://www.acerta-pharma.com/


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Bladder Cancer


CG0070 Cold Genesys non-muscle invasive bladder cancer Phase II/III(oncolytic virus therapy) Newport Beach, CA www.coldgenesys.com

CV-301 Bavarian Nordic bladder cancer Phase II(CEA/MUC-1 targeted active Mountain View, CA www.bavarian-nordic.comimmunotherapy)

Cyramza® Eli Lilly urothelial cancer Phase IIIramucirumab Indianapolis, IN (see also liver, lung, stomach) www.lilly.com

bladder cancer (2nd-line) Phase IIwww.lilly.com

DN24-02 Dendreon HER2-positive urothelial cancer Phase II(active cellular immunotherapy) Seattle, WA www.dendreon.com

Halaven® Eisai bladder cancer Phase I/IIeribulin Woodcliff Lake, NJ (see also lung, sarcoma) www.eisai.comOrphan Drug

instiladrin FKD Therapies superficial bladder cancer Phase II(gene therapy) Kuopia, Finland

JNJ-42756493 Janssen Research & Development urothelial cancer Phase II

(FGFR inhibitor) Raritan, NJ (see also lymphoma) www.janssenrnd.com

MCNA Telesta Therapeutics refractory non-muscle invasive application submitted(mycobacterium phlei cell Point Claire, Canada bladder cancer (Fast Track) www.telestatherapeutics.comwall-nucleic acid complex)

Keytruda® Merck bladder cancer Phase IIIpembrolizumab Kenilworth, NJ (see also breast, head/neck, lung, lymphoma, www.merck.com

stomach)

http://www.coldgenesys.com/http://www.bavarian-nordic.com/http://www.lilly.com/http://www.lilly.com/http://www.dendreon.com/http://www.eisai.com/http://www.janssenrnd.com/http://www.telestatherapeutics.com/http://www.merck.com/http://www.merck.com/http://www.telestatherapeutics.com/http://www.janssenrnd.com/http://www.eisai.com/http://www.dendreon.com/http://www.lilly.com/http://www.lilly.com/http://www.bavarian-nordic.com/http://www.coldgenesys.com/


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Bladder Cancer


mocetinostat Mirati Therapeutics bladder cancer Phase II(HDAC inhibitor) San Diego, CA (see also hematological, lymphoma) www.mirati.com

Opdivo® Bristol-Myers Squibb bladder cancer (2nd-line) Phase IInivolumab Princeton, NJ (see also brain, colorectal, head/neck, hematological, www.bms.com

kidney, liver, lung, lymphoma, skin, solid tumors,

stomach, other)

RG7446 Genentech/Roche bladder cancer (2nd-line) (Breakthrough Therapy) Phase III(anti-PD-L1 mAb) South San Francisco, CA muscle invasive bladder cancer (adjuvant) www.roche.com

(see also breast, kidney, lung, lymphoma, skin)

bladder cancer (1st-line) Phase IIwww.roche.com

TMX-101 Telormedix bladder cancer Phase II(TLR7 agonist) Bioggio, Switzerland www.telormedix.com

Orphan Drug

vesigenurtucel-L Heat Biologics bladder cancer Phase II(cancer immunotherapy) Durham, NC www.heatbio.com

2B3-101 BBB Therapeutics brain metastases in advanced solid tumors, Phase II(doxorubicin liposomal) Leiden, Netherlands brain metastases in breast cancer (combination therapy) www.bbbtherapeutics.com

ABT-414 AbbVie glioblastoma Phase I/II(antibody drug conjugate) North Chicago, IL (see also solid tumors) www.abbvie.comOrphan Drug

ADU-623 Aduro Biotech glioblastoma Phase I(therapeutic bivalent vaccine) Berkeley, CA www.adurobiotech.com

http://www.mirati.com/http://www.bms.com/http://www.gene.com/http://www.gene.com/http://www.telormedix.com/http://www.heatbio.com/http://www.bbbtherapeutics.com/http://www.abbvie.com/http://www.adurobiotech.com/http://www.adurobiotech.com/http://www.abbvie.com/http://www.bbbtherapeutics.com/http://www.heatbio.com/http://www.telormedix.com/http://www.gene.com/http://www.gene.com/http://www.bms.com/http://www.mirati.com/


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Brain Cancer


AG-120 Agios Pharmaceuticals glioma Phase I(IDH1 inhibitor) Cambridge, MA (see also leukemia, solid tumors) www.agios.com

Celgene www.celgene.comSummit, NJ

aglatimagene besadenovec Advantagene glioma Phase II(gene therapy) Auburndale, MA (see also pancreatic, prostate) www.advantagene.comOrphan Drug

glioma (pediatric) Phase I/IIwww.advantagene.com

aldoxorubicin CytRx glioblastoma Phase II(delivery-enhanced doxorubicin) Los Angeles, CA (see also lung, sarcoma) www.cytrx.comOrphan Drug

AMG 595 Amgen anaplastic astrocytoma, recurrent glioblastoma Phase I(anti-EGFRvIII antibody drug Thousand Oaks, CA www.amgen.comconjugate)

ANG 1005 Angiochem brain metastases from breast cancer and Phase II(peptide-paclitaxel conjugate) Montreal, Canada NSCLC, recurrent glioblastoma (Fast Track) www.angiochem.com

Orphan Drug

antineoplaston A10/AS2-1 Burzynski Research Institute diffuse intrinsic brainstem glioma Phase II

Orphan Drug Houston, TX www.burzynskiresearch.com

Avastin® Genentech/Roche glioblastoma (1st-line) Phase IIIbevacizumab South San Francisco, CA (see also breast, lung, ovarian, other) www.roche.com

BGJ398 Novartis Pharmaceuticals recurrent glioblastoma Phase II(FGF-R kinase inhibitor) East Hanover, NJ (see also solid tumors) www.novartis.com

http://www.agios.com/http://www.celgene.com/http://www.advantagene.com/http://www.advantagene.com/http://www.cytrx.com/http://www.amgen.com/http://www.angiochem.com/http://www.burzynskiresearch.com/http://www.gene.com/http://www.novartis.com/http://www.novartis.com/http://www.gene.com/http://www.burzynskiresearch.com/http://www.angiochem.com/http://www.amgen.com/http://www.cytrx.com/http://www.advantagene.com/http://www.advantagene.com/http://www.celgene.com/http://www.agios.com/


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Brain Cancer


buparlisib (BKM120) Novartis Pharmaceuticals glioblastoma Phase I/II(PI3K inhibitor) East Hanover, NJ (see also breast, solid tumors) www.novartis.com

CC-122 Celgene glioblastoma Phase I(pleiotropic pathway modifier) Summit, NJ (see also leukemia, liver, lymphoma) www.celgene.com

Cometriq® Exelixis astrocytoma, glioblastoma Phase II completedcabozantinib South San Francisco, CA (see also kidney, liver) www.exelixis.com

Cotara® Peregrine Pharmaceuticals recurrent glioblastoma (Fast Track) Phase II completediodine I 131 derlotuximab biotin Tustin, CA www.peregrine.com

Orphan Drug

crenolanib AROG Pharmaceuticals glioma (pediatric) Phase II(PDGFR inhibitor) Dallas, TX (see also leukemia, lung, stomach) www.arogpharma.com

Orphan Drug

CTO Tactical Therapeutics glioma (combination therapy) Phase I/II(carboxyamidotriazole orotate) New York, NY (Fast Track) www.tacticaltherapeutics.com

DCVax®-L Northwest Biotherapeutics glioblastoma Phase IIIdendritic cell-based vaccine Bethesda, MD www.nwbio.comOrphan Drug

DM-CHOC-PEN Dekk-Tec brain tumors Phase II(non-neurotoxic derivative of New Orleans, LA www.dekk-tec.compenclomidine)

DNX-2401 DNAtrix glioblastoma (Fast Track) Phase I(oncolytic virus) Houston, TX www.dnatrix.com

Orphan Drug

http://www.novartis.com/http://www.celgene.com/http://www.exelixis.com/http://www.peregrine.com/http://www.arogpharma.com/http://www.tacticaltherapeutics.com/http://www.nwbio.com/http://www.dekk-tec.com/http://www.dnatrix.com/http://www.dnatrix.com/http://www.dekk-tec.com/http://www.nwbio.com/http://www.tacticaltherapeutics.com/http://www.arogpharma.com/http://www.peregrine.com/http://www.exelixis.com/http://www.celgene.com/http://www.novartis.com/


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Brain Cancer


ERC1671 Epitopoietic Research grade IV glioblastoma Phase II(therapeutic vaccine) Pasadena, CA www.ercbelgium.com

University of CaliforniaIrvine, CA

ETS2101 e-Therapeutics glioma Phase I(dexanabinol) Oxfordshire, England www.etherapeutics.co.uk

Moores UCSD Cancer CenterLa Jolla, CA

evofosfamide (TH-302) Threshold Pharmaceuticals high grade glioma Phase I/II(hypoxia-activated prodrug) South San Francisco, CA (see also hematological, lung, pancreatic, sarcoma, www.thresholdpharm.com

University of Texas skin)San Antonio, TX

galunisertib Eli Lilly glioblastoma Phase II(TGF-beta 1 kinase inhibitor) Indianapolis, IN (see also liver, pancreatic) www.lilly.com

glioma Phase I/IIwww.lilly.com

Gilotrif® Boehringer Ingelheim Pharmaceuticals recurrent glioma Phase IIafatinib Ridgefield, CT (see also head/neck, lung) www.boehringer-ingelheim.com

heat shock protein vaccine Agenus recurrent or newly-diagnosed glioblastoma Phase II

(Prophage Series) Lexington, MA (see also skin) www.agenus.comOrphan Drug

ICT-107 ImmunoCellular Therapeutics newly-diagnosed glioblastoma Phase II(dendritic cell-based vaccine) Calabasas, CA www.imuc.com

Orphan Drug

http://www.ercbelgium.com/http://www.etherapeutics.co.uk/http://www.thresholdpharm.com/http://www.lilly.com/http://www.lilly.com/http://www.boehringer-ingelheim.com/http://www.agenus.com/http://www.imuc.com/http://www.imuc.com/http://www.agenus.com/http://www.boehringer-ingelheim.com/http://www.lilly.com/http://www.lilly.com/http://www.thresholdpharm.com/http://www.etherapeutics.co.uk/http://www.ercbelgium.com/


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Brain Cancer


ICT-121 ImmunoCellular Therapeutics recurrent glioblastoma Phase I(dendritic cell-based vaccine) Calabasas, CA www.imuc.com

indoximod NewLink Genetics primary malignant brain tumors Phase I/II(IDO pathway inhibitor) Ames, IA (see also breast, prostate) www.newlinkgenetics.com

INXN-2001 ZIOPHARM Oncology anaplastic oligo astrocytoma, glioblastoma Phase I/II(Ad-RTS-IL-12 gene therapy) Boston, MA (see also breast, skin) www.ziopharm.com

Jevtana® Sanofi US malignant central nervous system tumors Phase I/IIcabazitaxel Bridgewater, NJ (see also prostate) www.sanofi.com

KX02 Kinex Pharmaceuticals glioma Phase I(Src kinase/pre-tubulin inhibitor) Buffalo, NY www.kinexpharma.com

Orphan Drug

MM-398 Baxalta glioma Phase I(encapsulated irinotecan Cambridge, MA (see also pancreatic, solid tumors) www.baxalta.comnanotherapeutic)

macitentan Actelion Pharmaceuticals glioblastoma Phase I(endothelin A/B receptor antagonist) South San Francisco, CA www.actelion.com

marizomib Triphase Accelerator glioblastoma Phase I

(proteasome inhibitor) San Diego, CA (see also myeloma) www.triphaseco.com

mibefradil Cavion high-grade glioma Phase I(T-type calcium channel antagonist) Charlottesville, VA www.cavionpharma.com

Orphan Drug

mipsagargin GenSpera glioblastoma Phase II(thapsigargin analogue) San Antonio, TX (see also liver) www.genspera.com

http://www.imuc.com/http://www.newlinkgenetics.com/http://www.ziopharm.com/http://www.sanofi.com/http://www.kinexpharma.com/http://www.baxalta.com/http://www.actelion.com/http://www.triphaseco.com/http://www.cavionpharma.com/http://www.genspera.com/http://www.genspera.com/http://www.cavionpharma.com/http://www.triphaseco.com/http://www.actelion.com/http://www.baxalta.com/http://www.kinexpharma.com/http://www.sanofi.com/http://www.ziopharm.com/http://www.newlinkgenetics.com/http://www.imuc.com/


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Brain Cancer


NEO-100 NEONC Technologies recurrent glioblastoma Phase I(highly purified perillyl alcohol) Tucson, AZ www.neonctech.com

Orphan Drug

NVX-108 NuvOx Pharma glioblastoma Phase I/II(radiation-sensitizing agent) Tucson, AZ www.nuvoxpharma.com

National Cancer InstituteBethesda, MD

Odomzo® Novartis Pharmaceuticals medulloblastoma Phase IIsonidegib East Hanover, NJ (see also leukemia) www.novartis.com

Opdivo® Bristol-Myers Squibb glioblastoma Phase III

nivolumab Princeton, NJ (see also bladder, colorectal, head/neck, hematological, www.bms.comkidney, liver, lung, lymphoma, skin, solid tumors,stomach, other)

PEPIDH1M Annias Immunotherapeutics glioblastoma Phase I/II(dendritic cell vaccine) Chapel Hill, NC www.anniasimmuno.com

PLX3397 Plexxikon glioblastoma (adjuvant) Phase II(CSF-1R inhibitor) Berkeley, CA (see also breast, ovarian, skin, other) www.plexxikon.com

Poly-ICLC Oncovir glioblastoma Phase II

Orphan Drug Washington, DC www.oncovir.com

Reolysin® Oncolytics Biotech high grade glioma (pediatrics) Phase Ipelareorp Calgary, Canada (see also colorectal, head/neck, lung, www.oncolyticsbiotech.com

Orphan Drug myeloma, ovarian, other, pancreatic)

http://www.neonctech.com/http://www.nuvoxpharma.com/http://www.novartis.com/http://www.bms.com/http://www.anniasimmuno.com/http://www.plexxikon.com/http://www.oncovir.com/http://www.oncolyticsbiotech.com/http://www.oncolyticsbiotech.com/http://www.oncovir.com/http://www.plexxikon.com/http://www.anniasimmuno.com/http://www.bms.com/http://www.novartis.com/http://www.nuvoxpharma.com/http://www.neonctech.com/


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Brain Cancer


rindopepimut Celldex Therapeutics glioblastoma (1st-line) (Fast Track) Phase III(EGFR antagonist) Hampton, NJ www.celldex.com

Orphan Drug

recurrent glioblastoma (Fast Track) Phase IIwww.celldex.com

selinexor (oral) Karyopharm Therapeutics glioblastoma Phase II(XPO1 antagonist) Newton, MA (see also head/neck, hematological, leukemia, www.karyopharm.com

lymphoma, myeloma, prostate, sarcoma, other)

Seprehvir® Virttu Biologics glioblastoma Phase IHSV1716 Glasgow, Scotland (see also solid tumors) www.virttu.com

National Cancer InstituteBethesda, MD

SL-701 Stemline Therapeutics adult glioblastoma (first recurrence) Phase I/II(immunotherapy) New York, NY www.stemline.com

SurVaxM MimiVax malignant glioma Phase IBIRC5 protein inhibitor Buffalo, NY www.mimivax.com

Toca 511 + Toca FC Tocagen anaplastic astrocytoma, glioblastoma Phase II/III(gene therapy) San Diego, CA (Fast Track) www.tocagen.com

TPI 287 Cortice Biosciences recurrent glioblastoma Phase II(abeotaxane) New York, NY www.corticebio.com

breast cancer brain metastases, Phase Isecondary brain metastases www.corticebio.com

http://www.celldex.com/http://www.celldex.com/http://www.karyopharm.com/http://www.virttu.com/http://www.stemline.com/http://www.mimivax.com/http://www.tocagen.com/http://www.corticebio.com/http://www.corticebio.com/http://www.corticebio.com/http://www.corticebio.com/http://www.tocagen.com/http://www.mimivax.com/http://www.stemline.com/http://www.virttu.com/http://www.karyopharm.com/http://www.celldex.com/http://www.celldex.com/


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Brain Cancer


TRC105 TRACON Pharmaceuticals glioblastoma Phase II(END protein inhibitor) San Diego, CA (see also breast, colorectal, kidney, liver, lung, www.traconpharma.com

National Cancer Institute sarcoma, other)Bethesda, MD

TSC Diffusion Pharmaceuticals glioblastoma Phase I/II(trans-sodium crocetinate) Charlottesville, VA www.diffusionpharma.comOrphan Drug

TVI-Brain-1 TVAX Biomedical glioma Phase II(personalized cancer immunotherapy) Lenexa, KS www.tvaxbiomedical.comOrphan Drug

VAL-083 DelMar Pharmaceuticals glioblastoma Phase I/II(N7-alkylating agent) Vancouver, Canada www.delmarpharma.com

Orphan Drug

VB-111 VBL Therapeutics recurrent glioblastoma (Fast Track) Phase II(targeted anti-angiogenic agent) Tel Aviv, Israel (see also ovarian, other) www.vblrx.com

Orphan Drug

veliparib AbbVie brain metastases Phase II(PARP inhibitor) North Chicago, IL (see also breast, colorectal, lung, skin) www.abbvie.com

Breast Cancer


abemaciclib Eli Lilly metastatic breast cancer Phase III(CDK 4/6 inhibitor) Indianapolis, IN (see also lung, lymphoma) www.lilly.com

ABP 980 Allergan breast cancer Phase III(trastuzumab biosimilar) Parsippany, NJ www.amgen.com

AmgenThousand Oaks, CA

http://www.traconpharma.com/http://www.diffusionpharma.com/http://www.tvaxbiomedical.com/http://www.delmarpharma.com/http://www.vblrx.com/http://www.abbvie.com/http://www.lilly.com/http://www.amgen.com/http://www.amgen.com/http://www.lilly.com/http://www.abbvie.com/http://www.vblrx.com/http://www.delmarpharma.com/http://www.tvaxbiomedical.com/http://www.diffusionpharma.com/http://www.traconpharma.com/


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Breast Cancer


Abraxane® Celgene triple-negative breast cancer (1st-line) Phase IIIpaclitaxel protein-bound Summit, NJ (see also pancreatic) www.celgene.comparticles for injectablesuspension (albumin-bound)

ADI-PEG 20 Polaris Pharmaceuticals HER2-negative breast cancer Phase I(PEG arginine deiminase) San Diego, CA (see also liver, lung, ovarian, pancreatic, skin, www.polarispharma.com

stomach)

AE37 Antigen Express breast cancer Phase II(immunotherapeutics) Worcester, MA (see also prostate) www.antigenexpress.com

anti-HER2 Bristol-Myers Squibb breast cancer Phase IPrinceton, NJ www.bms.com

ARRY-380/ONT-380 Array BioPharma breast cancer Phase I(HER2 inhibitor) Boulder, CO www.arraybiopharma.com

Oncothyreon www.oncothyreon.comSeattle, WA

Avastin® Genentech/Roche HER2-negative breast cancer (adjuvant), Phase IIIbevacizumab South San Francisco, CA HER2-positive breast cancer (adjuvant) www.roche.com

(see also brain, lung, ovarian, other)

AZD5363 AstraZeneca breast cancer Phase II(Akt kinase inhibitor) Wilmington, DE www.astrazeneca.com

AZD9496 AstraZeneca estrogen receptor (ER)-positive breast cancer Phase I(selective estrogen receptor Wilmington, DE www.astrazeneca.comdownregulator [SERD])

bavituximab Peregrine Pharmaceuticals HER2-negative breast cancer Phase I completedTustin, CA (see also colorectal, lung, skin) www.peregrineinc.com

http://www.celgene.com/http://www.polarispharma.com/http://www.bms.com/http://www.arraybiopharma.com/http://www.oncothyreon.com/http://www.gene.com/http://www.astrazeneca.com/http://www.astrazeneca.com/http://www.peregrineinc.com/http://www.peregrineinc.com/http://www.astrazeneca.com/http://www.astrazeneca.com/http://www.gene.com/http://www.oncothyreon.com/http://www.arraybiopharma.com/http://www.bms.com/http://www.polarispharma.com/http://www.celgene.com/


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Breast Cancer


BBI608 Boston Biomedical breast cancer Phase II(cancer stem cell inhibitor) Cambridge, MA (see also colorectal, hematological, liver, lung, www.bostonbiomedical.com

ovarian, pancreatic, skin, stomach)

BEL-0222 Belrose Pharma triple-negative breast cancer Phase II(angiogenesis inhibitor) Princeton, NJ (see also other) www.belrosepharma.com

buparlisib (BKM120) Novartis Pharmaceuticals metastatic breast cancer (2nd-line) Phase III(PI3K inhibitor) East Hanover, NJ (ER-positive aromatase inhibitor (AI)- www.novartis.com

resistant mTOR naïve) (combination therapy)(see also brain, solid tumors)

metastatic breast cancer Phase II(ER-positive post-AI and mTOR inhibitor) www.novartis.com

CC-486 Celgene metastatic breast cancer Phase II(DNA methylation inhibitor) Summit, NJ (see also hematological, leukemia, lung, lymphoma, www.celgene.com

other)

cobimetinib Genentech/Roche triple-negative breast cancer (combination therapy) Phase II(MEK inhibitor) South San Francisco, CA (see also skin) www.roche.com

Cynviloq™ NantPharma breast cancer in clinical trialspaclitaxel polymeric micelle Lincolnshire, IL www.nantpharma.comfor injection

docetaxel injection concentrate, Teikoku Pharma USA breast cancer application submittednon-alcohol formula San Jose, CA (see also head/neck, lung, prostate, stomach) www.teikokuusa.com

DPX-0907 Immunovaccine breast cancer Phase I(T lymphocyte modulator) Halifax, Canada (see also ovarian, prostate) www.imvaccine.com

http://www.bostonbiomedical.com/http://www.belrosepharma.com/http://www.novartis.com/http://www.novartis.com/http://www.celgene.com/http://www.gene.com/http://www.nantpharma.com/http://www.teikokuusa.com/http://www.imvaccine.com/http://www.imvaccine.com/http://www.teikokuusa.com/http://www.nantpharma.com/http://www.gene.com/http://www.celgene.com/http://www.novartis.com/http://www.novartis.com/http://www.belrosepharma.com/http://www.bostonbiomedical.com/


13/146

Breast Cancer


ENMD-2076 CASI Pharmaceuticals triple-negative breast cancer Phase II(aurora A/angiogenic kinase Rockville, MD (see also ovarian, sarcoma) www.casipharmaceuticals.cominhibitor)

enobosarm GTx ER-positive and androgen receptor (AR)-positive Phase II(SARM) Memphis, TN breast cancer, AR-positive triple-negative www.gtxinc.com

breast cancer

entinostat Syndax Pharmaceuticals hormone receptor (HR)-positive metastatic Phase III(HDAC inhibitor) Waltham, MA breast cancer www.syndax.com

(see also lung, skin)

etirinotecan pegol (NKTR-102) Nektar Therapeutics metastatic breast cancer (Fast Track) Phase III(PEGylated irinotecan) San Francisco, CA (see also colorectal, ovarian) www.nektar.com

Faslodex® AstraZeneca HR-positive advanced breast cancer (1st-line) Phase IIIfulvestrant Wilmington, DE www.astrazeneca.com

ganetespib Synta Pharmaceuticals breast cancer Phase II(Hsp90 inhibitor) Lexington, MA (see also leukemia, lung, ovarian) www.syntapharma.com

GDC-0810 Genentech/Roche ER-positive HER2-negative breast cancer Phase I(SERD) South San Francisco, CA www.roche.com

glembatumumab vedotin CellDex Therapeutics triple-negative breast cancer (Fast Track) Phase II(antibody drug conjugate) Hampton, NJ (see also skin) www.celldex.com

HER2 cancer immunotherapy AlphaVax late-stage breast cancer Phase I/II(AVX901) Research Triangle Park, NC www.alphavax.com

http://www.casipharmaceuticals.com/http://www.gtxinc.com/http://www.syndax.com/http://www.nektar.com/http://www.astrazeneca.com/http://www.syntapharma.com/http://www.gene.com/http://www.celldex.com/http://www.alphavax.com/http://www.alphavax.com/http://www.celldex.com/http://www.gene.com/http://www.syntapharma.com/http://www.astrazeneca.com/http://www.nektar.com/http://www.syndax.com/http://www.gtxinc.com/http://www.casipharmaceuticals.com/


14/146

Breast Cancer


Ibrance® Pfizer high-risk early breast cancer, Phase IIIpalbociclib New York, NY recurrent advanced breast cancer www.pfizer.com

(see also hematological)

IMMU-132 Immunomedics relapsed/refractory triple-negative breast cancer Phase II(sacituzumab govitecan) Morris Plains, NJ (Fast Track) www.immunomedics.com

(see also other)

indoximod NewLink Genetics metastatic HER2-negative breast cancer Phase II(IDO pathway inhibitor) Ames, IA (see also brain, prostate) www.newlinkgenetics.com

INO-1400 Inovio Pharmaceuticals breast cancer Phase I(hTERT immunotherapy) Plymouth Meeting, PA (see also lung, pancreatic) www.inovio.com

interleukin-12 gene therapy OncoSec Medical triple-negative breast cancer Phase IISan Diego, CA (see also head/neck, skin) www.oncosec.com

INXN-2001 ZIOPHARM Oncology breast cancer Phase II(Ad-RTS-IL-12 gene therapy) Boston, MA (see also brain, skin) www.ziopharm.com

ipatasertib Array BioPharma triple-negative breast cancer Phase II(Akt inhibitor) Boulder, CO (see also prostate, stomach) www.roche.com

Genentech/RocheSouth San Francisco, CA

Jakafi® Incyte breast cancer Phase IIruxolitinib Wilmington, DE (see also colorectal, lung, pancreatic) www.incyte.com

Kadcyla® Genentech/Roche HER2-positive breast cancer (adjuvant monotherapy), Phase IIIado-trastuzumab emtansine South San Francisco, CA HER2-positive breast cancer (adjuvant combination www.roche.com

therapy), HER2-positive breast cancer(neoadjuvant combination therapy)(see also lung, stomach)

http://www.pfizer.com/http://www.immunomedics.com/http://www.newlinkgenetics.com/http://www.inovio.com/http://www.oncosec.com/http://www.ziopharm.com/http://www.gene.com/http://www.incyte.com/http://www.gene.com/http://www.gene.com/http://www.incyte.com/http://www.gene.com/http://www.ziopharm.com/http://www.oncosec.com/http://www.inovio.com/http://www.newlinkgenetics.com/http://www.immunomedics.com/http://www.pfizer.com/


15/146

Breast Cancer


Keytruda® Merck breast cancer Phase IIpembrolizumab Kenilworth, NJ (see also bladder, head/neck, lung, lymphoma, www.merck.com

stomach)

LEE011 Novartis Pharmaceuticals HR-positive HER2-negative postmenopausal Phase III(CDK4/6 inhibitor) East Hanover, NJ advanced breast cancer (1st-line) www.novartis.com

(combination therapy)

HR-positive HER2-negative premenopausal Phase IIadvanced breast cancer (1st-line) www.novartis.com(combination therapy)

HR-positive HER2-negative premenopausal Phase Iadvanced breast cancer (1st-/2nd-line) www.novartis.com(combination therapy)

lucitanib Clovis Oncology metastatic breast cancer Phase II(FGFR/VEGFR/PDGFR inhibitor) Boulder, CO (see also lung) www.clovisoncology.com

LY2606368 Eli Lilly metastatic breast cancer Phase II(Chk1 inhibitor) Indianapolis, IN (see also ovarian) www.lilly.com

Lynparza® AstraZeneca germline BRCA-mutated triple-negative breast Phase IIIolaparib Wilmington, DE cancer (adjuvant), germline BRCA-mutated www.astrazeneca.com

metastatic breast cancer(see also ovarian, pancreatic, prostate, stomach)

margetuximab MacroGenics metastatic breast cancer Phase II(anti-HER2 mAb) Rockville, MD www.macrogenics.com

MEDI-573 MedImmune metastatic breast cancer Phase II(anti-CD19 mAb) Gaithersburg, MD www.medimmune.com

http://www.merck.com/http://www.novartis.com/http://www.novartis.com/http://www.novartis.com/http://www.clovisoncology.com/http://www.lilly.com/http://www.astrazeneca.com/http://www.macrogenics.com/http://www.medimmune.com/http://www.medimmune.com/http://www.macrogenics.com/http://www.astrazeneca.com/http://www.lilly.com/http://www.clovisoncology.com/http://www.novartis.com/http://www.novartis.com/http://www.novartis.com/http://www.merck.com/


16/146

Breast Cancer


mifepristone Corcept Therapeutics triple-negative breast cancer Phase IMenlo Park, CA www.corcept.com

MM-302 Merrimack Pharmaceuticals advanced HER2-positive breast cancer Phase II(HER2-targeted nanotheraputic) Cambridge, MA www.merrimackpharma.com

NeuVax™ Galena Biopharma node-positive breast cancer Phase IIInelipepimut-S Portland, OR (HER2 IHC 1+/2+) www.galenabiopharma.com

(see also stomach)

node-positive and triple-negative Phase IIbreast cancer (HER2 IHC 1+/2+) www.galenabiopharma.com(combination therapy)

neoadjuvant node-positive and negative Phase IIbreast cancer (HER2 IHC 3+) www.galenabiopharma.com(combination therapy)

niraparib TESARO BRCA-positive breast cancer Phase III(PARP inhibitor) Waltham, MA (see also ovarian, sarcoma) www.tesarobio.com

NK012 Nippon Kayaku breast cancer Phase II(DNA topoisomerase I inhibitor) Tokyo, Japan (see also colorectal, lung) www.nipponkayaku.co.jp

ONT-10 Oncothyreon breast cancer Phase I

(cancer immunotherapy) Seattle, WA (see also ovarian) www.oncothyreon.com

OPT-822/OPT-821 OBI Pharma metastatic breast cancer Phase II/III(cancer immunotherapy) Taipei, Taiwan www.obipharma.com

patritumab Daiichi Sankyo breast cancer Phase II(anti-HER3 antibody) Parsippany, NJ (see also lung) www.dsi.com

http://www.corcept.com/http://www.merrimackpharma.com/http://www.galenabiopharma.com/http://www.galenabiopharma.com/http://www.galenabiopharma.com/http://www.tesarobio.com/http://www.nipponkayaku.co.jp/http://www.oncothyreon.com/http://www.obipharma.com/http://www.dsi.com/http://www.dsi.com/http://www.obipharma.com/http://www.oncothyreon.com/http://www.nipponkayaku.co.jp/http://www.tesarobio.com/http://www.galenabiopharma.com/http://www.galenabiopharma.com/http://www.galenabiopharma.com/http://www.merrimackpharma.com/http://www.corcept.com/


17/146

Breast Cancer


PB272 Puma Biotechnology breast cancer (adjuvant), metastatic Phase III(neratinib) Los Angeles, CA breast cancer (combination therapy) www.pumabiotechnology.com

(see also lung)

metastatic breast cancer (combination Phase IItherapy), breast cancer with brain www.pumabiotechnology.commetastases (combination therapy)(combination therapy), breast cancer(neoadjuvant)

Perjeta® Genentech/Roche early HER2-positive breast cancer, Phase IIIpertuzumab South San Francisco, CA HER2-positive metastatic breast cancer www.roche.com

(2nd-line)(see also stomach)

PF-05280014 Pfizer metastatic breast cancer Phase III(trastuzumab biosimilar) New York, NY www.pfizer.com

pictilisib Genentech/Roche ER-positive breast cancer, metastatic Phase II(PI3K inhibitor) South San Francisco, CA HER2-negative/HR-positive breast cancer www.roche.com

(see also lung)

PLX3397 Plexxikon metastatic breast cancer Phase II(CSF-1R inhibitor) Berkeley, CA (see also brain, ovarian, skin, other) www.plexxikon.com

PM01183 Pharma Mar metastatic breast cancer Phase II

(marine-derived alkylating agent) Madrid, Spain (see also leukemia, ovarian) www.pharmamar.com

POL6326 Polyphor metastatic breast cancer Phase I(CXCR4 receptor antagonist) Allschwil, Switzerland (see also hematological) www.polyphor.com

pyrotinib Jiangsu Hengrui Medicine HER2-positive breast cancer Phase I(tyrosine kinase inhibitor) Jiangsu Province, China (see also stomach) www.hrs.com.cn

http://www.pumabiotechnology.com/http://www.pumabiotechnology.com/http://www.gene.com/http://www.pfizer.com/http://www.gene.com/http://www.plexxikon.com/http://www.pharmamar.com/http://www.polyphor.com/http://www.hrs.com.cn/http://www.hrs.com.cn/http://www.polyphor.com/http://www.pharmamar.com/http://www.plexxikon.com/http://www.gene.com/http://www.pfizer.com/http://www.gene.com/http://www.pumabiotechnology.com/http://www.pumabiotechnology.com/


18/146

Breast Cancer


RAD1901 Radius Health metastatic breast cancer Phase I(SERM modulator) Waltham, MA www.radiuspharm.com

reparixin Dompe early-stage breast cancer Phase II(IL-8A/B receptor antagonist) Milan, Italy www.dompe.com

metastatic breast cancer Phase Iwww.dom e.com

RG6047 Genentech/Roche ER-positive HER2-negative metastatic breast cancer Phase I(SERD) South San Francisco, CA www.roche.com

RG7116 Genentech/Roche metastatic breast cancer Phase I(ERBB-3 receptor antagonist) South San Francisco, CA www.roche.com

RG7446 Genentech/Roche triple-negative breast cancer Phase III(anti-PD-L1 mAb) South San Francisco, CA (see also bladder, kidney, lung, lymphoma, skin) www.roche.com

rucaparib Clovis Oncology breast cancer Phase II(PARP inhibitor) Boulder, CO (see also ovarian, pancreatic, other) www.clovisoncology.com

seribantumab (MM-121) Merrimack Pharmaceuticals breast cancer Phase II(ErbB-3 receptor antagonist) Cambridge, MA (see also lung, ovarian) www.merrimackpharma.com

SGN-LIV1A Seattle Genetics relapsed breast cancer Phase I(antibody drug conjugate) Bothell, WA www.seattlegenetics.com

TAK-228 Takeda Oncology breast cancer Phase II(mTORC1/2 inhibitor) Cambridge, MA (see also kidney, other) www.takedaoncology.com

talazoparib BioMarin Pharmaceutical metastatic breast cancer Phase III(PARP inhibitor) Novato, CA (genetically defined) www.bmrn.com

http://www.radiuspharm.com/http://www.dompe.com/http://www.dompe.com/http://www.gene.com/http://www.gene.com/http://www.gene.com/http://www.clovisoncology.com/http://www.merrimackpharma.com/http://www.seattlegenetics.com/http://www.takedaoncology.com/http://www.bmrn.com/http://www.bmrn.com/http://www.takedaoncology.com/http://www.seattlegenetics.com/http://www.merrimackpharma.com/http://www.clovisoncology.com/http://www.gene.com/http://www.gene.com/http://www.gene.com/http://www.dompe.com/http://www.dompe.com/http://www.radiuspharm.com/


19/146

Breast Cancer


taselisib Genentech/Roche ER-positive HER2-negative metastatic Phase III(PI3K inhibitor) South San Francisco, CA breast cancer www.roche.com

ER-positive HER2-negative breast cancer Phase IIwww.roche.com

tesevatinib (KD019) Kadmon Pharmaceuticals HER2-positive metastatic breast cancer Phase I/II(TKI inhibitor) Warrendale, PA (see also lung) www.kadmon.com

ThermoDox® Celsion recurrent breast cancer Phase IIdoxorubicin liposomal Lawrenceville, NJ (see also liver) www.celsion.com

TPIV100 TapImmune breast cancer Phase I(cancer immunotherapy) Seattle, WA www.tapimmune.com

TPIV200 TapImmune breast cancer (combination therapy) Phase I(folate receptor alpha vaccine) Seattle, WA (see also ovarian) www.tapimmune.com

TRC105 TRACON Pharmaceuticals breast cancer Phase I(END protein inhibitor) San Diego, CA (see also brain, colorectal, kidney, liver, lung, sarcoma, www.traconpharma.com

other)

trebananib Amgen metastatic breast cancer Phase I(Ang 1 / Ang 2 inhibitor) Thousand Oaks, CA (see also lung, ovarian) www.amgen.com

vantictumab OncoMed Pharmaceuticals HER2-negative breast cancer (combination therapy) Phase I(anti-Fzd7) Redwood City, CA (see also lung, pancreatic) www.oncomed.com

veliparib AbbVie BRCA-deficient breast cancer, triple-negative Phase III(PARP inhibitor) North Chicago, IL breast cancer (neoadjuvant therapy) www.abbvie.com

(see also brain, colorectal, lung, skin)

http://www.gene.com/http://www.gene.com/http://www.kadmon.com/http://www.celsion.com/http://www.tapimmune.com/http://www.tapimmune.com/http://www.traconpharma.com/http://www.amgen.com/http://www.oncomed.com/http://www.abbvie.com/http://www.abbvie.com/http://www.oncomed.com/http://www.amgen.com/http://www.traconpharma.com/http://www.tapimmune.com/http://www.tapimmune.com/http://www.celsion.com/http://www.kadmon.com/http://www.gene.com/http://www.gene.com/


20/146

Breast Cancer


Xgeva® Amgen delay of prevention of bone metastases in Phase IIIdenosumab Thousand Oaks, CA breast cancer www.amgen.com

(see also lung, myeloma)

Xtandi® Astellas Pharma US breast cancer Phase IIenzalutamide Northbrook, IL (see also liver, prostate) www.astellas.com

Medivation www.medivation.comSan Francisco, CA

Zytiga® Janssen Research & Development metastatic ER-positive HER2 negative Phase IIabiraterone acetate Raritan, NJ breast cancer in post-menopausal women www.janssenrnd.com

Colorectal Cancer


ABP 494 Allergan metastatic colorectal cancer Phase III(bevacizumab biosimilar) Parsippany, NJ www.amgen.com

AmgenThousand Oaks, CA

bavituximab Peregrine Pharmaceuticals rectal cancer Phase ITustin, CA (see also breast, lung, skin) www.peregrineinc.com

BBI608 Boston Biomedical colorectal cancer Phase III(cancer stem cell inhibitor) Cambridge, MA (see also breast, hematological, liver, www.bostonbiomedical.com

lung, ovarian, pancreatic, skin, stomach)

colorectal cancer (combination therapy) Phase IIIwww.bostonbiomedical.com

http://www.amgen.com/http://www.astellas.com/http://www.medivation.com/http://www.janssenrnd.com/http://www.amgen.com/http://www.peregrineinc.com/http://www.bostonbiomedical.com/http://www.bostonbiomedical.com/http://www.bostonbiomedical.com/http://www.bostonbiomedical.com/http://www.peregrineinc.com/http://www.amgen.com/http://www.janssenrnd.com/http://www.medivation.com/http://www.astellas.com/http://www.amgen.com/


21/146

Colorectal Cancer


CEA cancer immunotherapy AlphaVax late-stage colorectal cancer Phase I/II(AVX701) Research Triangle Park, NC www.alphavax.com

Duke UniversityDurham, NC

CPX-1 Celator Pharmaceuticals colorectal cancer Phase II(irinotecan/floxuridine liposomal) Ewing, NJ www.celatorpharma.com

CRLX101 Cerulean Pharma non-metastatic rectal cancer Phase II(nanoparticle drug conjugate) Cambridge, MA (see also kidney, ovarian) www.ceruleanrx.com

E7820 Eisai colorectal cancer Phase II(integrin alpha2 inhibitor) Woodcliff Lake, NJ www.eisai.com

encapsulated cell therapy Rogosin Institute metastatic colorectal cancer Phase IINew York, NY (see also pancreatic, prostate) www.rogosin.orgMetromedia Bio-Science www.metromediabioscience.comNew York, NY

ensituximab Precision Biologics advanced colorectal cancer Phase II(neoplasm antigen inhibitor) Dallas, TX (see also pancreatic) www.precision-biologics.com

ETBX-011 Etubics colorectal cancer Phase II(vector cancer vaccine) Seattle, WA www.etubics.com

etirinotecan pegol (NKTR-102) Nektar Therapeutics colorectal cancer (2nd-line) Phase II completed(PEGylated irinotecan) San Francisco, CA (see also breast, ovarian) www.nektar.com

GEN 1 Celsion colorectal cancer Phase II(cancer immunotherapy) Lawrenceville, NJ (see also ovarian) www.celsion.com

imalumab (BAX 069) Baxalta metastatic colorectal cancer Phase II(MIF inhibitor) Cambridge, MA www.baxalta.com

http://www.alphavax.com/http://www.celatorpharma.com/http://www.ceruleanrx.com/http://www.eisai.com/http://www.rogosin.org/http://www.metromediabioscience.com/http://www.precision-biologics.com/http://www.etubics.com/http://www.nektar.com/http://www.celsion.com/http://www.baxalta.com/http://www.baxalta.com/http://www.celsion.com/http://www.nektar.com/http://www.etubics.com/http://www.precision-biologics.com/http://www.metromediabioscience.com/http://www.rogosin.org/http://www.eisai.com/http://www.ceruleanrx.com/http://www.celatorpharma.com/http://www.alphavax.com/


22/146

Colorectal Cancer


Imprime PGG® Biothera metastatic colorectal cancer (3rd-line) Phase IIIintravenous immunostimulant Eagan, MN (see also leukemia, lung, lymphoma, pancreatic) www.biothera.com

Jakafi® Incyte colorectal cancer Phase IIruxolitinib Wilmington, DE (see also breast, lung, pancreatic) www.incyte.com

labetuzumab-SN-38 Immunomedics metastatic colorectal cancer Phase II(IMMU-130) Morris Plains, NJ www.immunomedics.com

MGD007 MacroGenics late-stage colorectal cancer Phase I(gpA33/CD3 bispecific antibody) Rockville, MD www.macrogenics.com

MORAb-004 Eisai colorectal cancer Phase II(CD248 antigen inhibitor) Woodcliff Lake, NJ (see also sarcoma, skin) www.eisai.com

NK012 Nippon Kayaku colorectal cancer Phase II(DNA topoisomerase I inhibitor) Tokyo, Japan (see also breast, lung) www.nipponkayaku.co.jp

OncoVAX® Vaccinogen stage II colon cancer (Fast Track) Phase IIIcancer immunotherapy Frederick, MD www.vaccinogeninc.com

Opdivo® Bristol-Myers Squibb microsatellite instability (MSI)-positive colon cancer Phase IInivolumab Princeton, NJ (see also bladder, brain, head/neck, hematological, www.bms.com


stomach, other)

polyclonal antibody stimulator Cancer Advances colorectal cancer Phase II completed(G17DT) Durham, NC (see also pancreatic, stomach) www.canceradvancesinc.com

Reolysin® Oncolytics Biotech metastatic colorectal cancer Phase Ipelareorp Calgary, Canada (see also brain, head/neck, lung, myeloma, ovarian, www.oncolyticsbiotech.com

other, pancreatic)

http://www.biothera.com/http://www.incyte.com/http://www.immunomedics.com/http://www.macrogenics.com/http://www.eisai.com/http://www.nipponkayaku.co.jp/http://www.vaccinogeninc.com/http://www.bms.com/http://www.canceradvancesinc.com/http://www.oncolyticsbiotech.com/http://www.oncolyticsbiotech.com/http://www.canceradvancesinc.com/http://www.bms.com/http://www.vaccinogeninc.com/http://www.nipponkayaku.co.jp/http://www.eisai.com/http://www.macrogenics.com/http://www.immunomedics.com/http://www.incyte.com/http://www.biothera.com/


23/146

Colorectal Cancer


RG7221 Genentech/Roche metastatic colorectal cancer Phase II(Ang2-VEGF mAb) South San Francisco, CA www.roche.com

RRx-001 EpicentRx metastatic colorectal cancer Phase II(free radical stimulant) Mountain View, CA (see also liver, lung, lymphoma, other) www.radiorx.com

SM04755 Samumed advanced colorectal cancer Phase I(Wnt inhibitor) San Diego, CA (see also liver, pancreatic, stomach) www.samumed.com

Stivarga® Bayer HealthCare Pharmaceuticals colorectal cancer with resected liver metastases Phase IIIregorafenib Whippany, NJ (see also kidney, liver) www.healthcare.bayer.com

Tafinlar® Novartis Pharmaceuticals BRAF V600-positive colorectal cancer Phase I/IIdabrafenib East Hanover, NJ (see also lung, skin) www.novartis.com

Mekinist™

trametinibcombination

TAS-102 Taiho Oncology colorectal cancer (Fast Track) application submitted(tipiracil/trifluridine) Princeton, NJ (see also stomach) www.taihooncology.com

TRC105 TRACON Pharmaceuticals colorectal cancer Phase I(END protein inhibitor) San Diego, CA (see also brain, breast, kidney, liver, lung, www.traconpharma.com

sarcoma, other)

Vargatef® Boehringer Ingelheim Pharmaceuticals metastatic colorectal cancer Phase IIInintedanib Ridgefield, CT (see also lung, ovarian) www.boeringer-ingelheim.com

Vectibix® Amgen chemo refractory wild-type KRAS exon 2 Phase IIIpanitumumab Thousand Oaks, CA metastatic colorectal cancer www.amgen.com

veliparib AbbVie metastatic colorectal cancer Phase II(PARP inhibitor) North Chicago, IL (see also brain, breast, lung, skin) www.abbvie.com

http://www.gene.com/http://www.radiorx.com/http://www.samumed.com/http://www.novartis.com/http://www.taihooncology.com/http://www.traconpharma.com/http://www.boeringer-ingelheim.com/http://www.amgen.com/http://www.abbvie.com/http://www.abbvie.com/http://www.amgen.com/http://www.boeringer-ingelheim.com/http://www.traconpharma.com/http://www.taihooncology.com/http://www.novartis.com/http://www.samumed.com/http://www.radiorx.com/http://www.gene.com/


24/146

Head and Neck Cancer


Xilonix™ XBiotech metastatic colorectal cancer (Fast Track) Phase IIIIgG1k Mab Austin, TX www.xbiotech.com

Zelboraf® Genentech/Roche BRAF mutation-positive metastatic Phase IIIvemurafenib South San Francisco, CA colorectal cancer (adjuvant) www.roche.com

Daiichi Sankyo (see also skin, other)Parsippany, NJ

ACP-196 Acerta Pharma advanced head and neck cancer Phase II(Btk inhibitor) San Carlos, CA (combination therapy) www.acerta-pharma.com

(see also bladder, hematological, leukemia, lung,

lymphoma, myeloma, pancreatic)

Ad-IL-24 MultiVir head and neck cancer Phase II(interleukin-24 gene therapy) San Diego, CA www.multivir.com

ADXS-HPV Advaxis head and neck cancer (neoadjuvant) Phase II(immunotherapy vaccine) Princeton, NJ (see also other) www.advaxis.com

Orphan Drug

metastatic head and neck cancer Phase I/II(combination therapy) www.advaxis.com

docetaxel injection concentrate, Teikoku Pharma USA head and neck cancer application submittednon-alcohol formula San Jose, CA (see also breast, lung, prostate, stomach) www.teikokuusa.com

GC4419 Galera Therapeutics head and neck cancer (1st-line) Phase I(superoxide dismutase modulator) Malvern, PA www.galeratx.com

Gilotrif® Boehringer Ingelheim Pharmaceuticals squamous cell carcinoma of the head and neck Phase IIIafatinib Ridgefield, CT (see also brain, lung) www.boehringer-ingelheim.com

http://www.xbiotech.com/http://www.gene.com/http://www.acerta-pharma.com/http://www.multivir.com/http://www.advaxis.com/http://www.advaxis.com/http://www.teikokuusa.com/http://www.galeratx.com/http://www.boehringer-ingelheim.com/http://www.boehringer-ingelheim.com/http://www.galeratx.com/http://www.teikokuusa.com/http://www.advaxis.com/http://www.advaxis.com/http://www.multivir.com/http://www.acerta-pharma.com/http://www.gene.com/http://www.xbiotech.com/


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GL-0817 Gliknik squamous cell cancer of the oral cavity Phase II(cancer immunotherapy) Baltimore, MD www.gliknik.com

Orphan Drug

GL-ONC1 Genelux head and neck cancer Phase I(oncolytic virus immunomodulator) San Diego, CA (see also lung, other) www.genelux.com

HF10 Takara Bio head and neck cancer Phase I(oncolytic virus immunomodulator) Shiga, Japan (see also skin) www.takara-bio.com

INO-3112 Inovio Pharmaceuticals head and neck cancer caused by HPV Phase I/II(cancer immunotherapy) Plymouth Meeting, PA types 16 and 18 www.inovio.com

(see also other)

interleukin-12 gene therapy OncoSec Medical metastatic head and neck cancer Phase IISan Diego, CA (see also breast, skin) www.oncosec.com

IRX-2 IRX Therapeutics head and neck cancer Phase II(immunostimulant) New York, NY www.irxtherapeutics.com

Keytruda® Merck head and neck cancer Phase IIIpembrolizumab Kenilworth, NJ (see also bladder, breast, lung, lymphoma, www.merck.com

stomach)

MEDI4736 MedImmune squamous cell head and neck cancer (2nd-line) Phase III

(anti-PD-L1 mAb) Gaithersburg, MD (see also lung, solid tumors) www.medimmune.com

MGA271 Macrogenics squamous cell cancer of the head and neck Phase I(CD276 protein inhibitor) Rockville, MD (combination therapy) www.macrogenics.com

(see also lung, skin)

Multikine® CEL-SCI head and neck cancer (1st-line) Phase IIIleukocyte interleukin injection Vienna, VA www.cel-sci.com

http://www.gliknik.com/http://www.genelux.com/http://www.takara-bio.com/http://www.inovio.com/http://www.oncosec.com/http://www.irxtherapeutics.com/http://www.merck.com/http://www.medimmune.com/http://www.macrogenics.com/http://www.cel-sci.com/http://www.cel-sci.com/http://www.macrogenics.com/http://www.medimmune.com/http://www.merck.com/http://www.irxtherapeutics.com/http://www.oncosec.com/http://www.inovio.com/http://www.takara-bio.com/http://www.genelux.com/http://www.gliknik.com/


26/146



motolimod VentiRx Pharmaceuticals head and neck cancer Phase II(TLR8 agonist immunotherapy) Seattle, WA (see also ovarian) www.ventirx.com

Opdivo® Bristol-Myers Squibb head and neck cancer (2nd-line) Phase IIInivolumab Princeton, NJ (see also bladder, brain, colorectal, hematological, www.bms.com


stomach, other)

Reolysin® Oncolytics Biotech platinum-refractory head and neck cancer Phase IIIpelareorp Calgary, Canada (see also brain, colorectal, lung, myeloma, www.oncolyticsbiotech.com

ovarian, other, pancreatic)

RM-1929 Aspyrian Therapeutics recurrent head and neck cancer Phase I(EGFR antagonist) San Diego, CA www.aspyriantherapeutics.com

selinexor (oral) Karyopharm Therapeutics head and neck squamous cell carcinoma Phase II(XPO1 antagonist) Newton, MA (see also brain, hematological, leukemia, lymphoma, www.karyopharm.com

myeloma, prostate, sarcoma, other)

Hematological Malignancies


ACP-196 Acerta Pharma B-cell malignancies (combination therapy) Phase I/II(Btk inhibitor) San Carlos, CA (see also bladder, head/neck, leukemia, lung, www.acerta-pharma.com

lymphoma, myeloma, pancreatic)

ALT-803 Altor BioScience hematological malignancies Phase I/II(IL-15 superagonist complex) Miramar, FL (see also bladder, myeloma, skin) www.altorbioscience.com

AMG 319 Amgen hematological malignancies Phase I(PI3K-delta inhibitor) Thousand Oaks, CA www.amgen.com

http://www.ventirx.com/http://www.bms.com/http://www.oncolyticsbiotech.com/http://www.aspyriantherapeutics.com/http://www.karyopharm.com/http://www.acerta-pharma.com/http://www.altorbioscience.com/http://www.amgen.com/http://www.amgen.com/http://www.altorbioscience.com/http://www.acerta-pharma.com/http://www.karyopharm.com/http://www.aspyriantherapeutics.com/http://www.oncolyticsbiotech.com/http://www.bms.com/http://www.ventirx.com/


27/146



AMG 900 Amgen hematological malignancies Phase I(aurora kinase inhibitor) Thousand Oaks, CA (see also solid tumors) www.amgen.com

anti-LAG3 Bristol-Myers Squibb hematological malignancies Phase IPrinceton, NJ www.bms.com

APTO-253 Aptose Biosciences relapsed/refractory blood cancers Phase I(MTF-1 inhibitor) San Diego, CA www.aptose.com

AR-42 Arno Therapeutics hematological malignancies Phase I/II(pan-DAC inhibitor) Flemington, NJ (see also solid tumors) www.arnothera.com

Aranesp® Amgen low-risk myelodysplastic syndromes Phase IIIdarbepoetin alfa Thousand Oaks, CA www.amgen.com

ASB183 Novartis Pharmaceuticals hematological malignancies Phase IEast Hanover, NJ (see also solid tumors) www.novartis.com

ASTX727 Astex Pharmaceuticals myelodysplastic syndromes Phase IDNA methylation inhibitor/ Pleasanton, CA www.astx.comnucleoside deaminase inhibitor)

AZD9150 AstraZeneca hematological malignancies Phase I(STAT3 inhibitor) Wilmington, DE www.astrazeneca.com

Isis Pharmaceuticals www.isispharm.comCarlsbad, CA

BBI608 Boston Biomedical hematological malignancies Phase I(cancer stem cell inhibitor) Cambridge, MA (see also breast, colorectal, liver, www.bostonbiomedical.com

lung, ovarian, pancreatic, skin, stomach)

http://www.amgen.com/http://www.bms.com/http://www.aptose.com/http://www.arnothera.com/http://www.amgen.com/http://www.novartis.com/http://www.astx.com/http://www.astrazeneca.com/http://www.isispharm.com/http://www.bostonbiomedical.com/http://www.bostonbiomedical.com/http://www.isispharm.com/http://www.astrazeneca.com/http://www.astx.com/http://www.novartis.com/http://www.amgen.com/http://www.arnothera.com/http://www.aptose.com/http://www.bms.com/http://www.amgen.com/


28/146



BB-MPI-03 Benovus Bio myelodysplastic syndromes Phase I(multi-peptide immunotherapy) Atlanta, GA (see also leukemia, myeloma) www.benovusbio.com

BI 836858 Boehringer Ingelheim Pharmaceuticals myelodysplastic syndromes Phase I/IIRidgefield, CT (see also leukemia) www.boehringer-ingelheim.com

birinapant TetraLogic Pharmaceuticals myelodysplastic syndromes Phase II(apoptosis stimulator) Malvern, PA (see also lymphoma, ovarian) www.tetralogicpharma.com

BP-100-1-01 Bio-Path Holdings myelodysplastic syndromes Phase I(liposomal Grb 2) Houston, TX (see also leukemia) www.biopathholdings.com

BPX-501 Bellicum Pharmaceuticals adjunct T-cell therapy following bone marrow Phase I/II(T-cell replacement therapy) Houston, TX transplantation in hematological malignancies www.bellicum.com

brontictuzumab OncoMed Pharmaceuticals hematological malignancies Phase I(NOTCH-1 inhibitor) Redwood City, CA (see also solid tumors) www.oncomed.com

BVD-523 BioMed Valley Discoveries myelodysplastic syndromes Phase I/II(ERK 1/2 kinase inhibitor) Kansas City, MO (see also leukemia, solid tumors) www.biomed-valley.com

CB-839 Calithera Biosciences hematological malignancies Phase I(glutaminase inhibitor) South San Francisco, CA (see also solid tumors) www.calithera.com

CC-486 Celgene myelodysplastic syndromes (lower risk) Phase III(DNA methylation inhibitor) Summit, NJ (see also breast, leukemia, lung, lymphoma, other) www.celgene.com

post hypomethylating agent (HMA) failure in Phase IImyelodysplastic syndromes www.celgene.com

CDX-301 Celldex Therapeutics stem cell transplantation in hematological Phase II(Fms-like tyrosine kinase 3 ligand) Hampton, NJ malignancies www.celldex.com

(see also lymphoma)

http://www.benovusbio.com/http://www.boehringer-ingelheim.com/http://www.tetralogicpharma.com/http://www.biopathholdings.com/http://www.bellicum.com/http://www.oncomed.com/http://www.biomed-valley.com/http://www.calithera.com/http://www.celgene.com/http://www.celgene.com/http://www.celldex.com/http://www.celldex.com/http://www.celgene.com/http://www.celgene.com/http://www.calithera.com/http://www.biomed-valley.com/http://www.oncomed.com/http://www.bellicum.com/http://www.biopathholdings.com/http://www.tetralogicpharma.com/http://www.boehringer-ingelheim.com/http://www.benovusbio.com/


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CM-CS1 Celyad hematological malignancies Phase I(NKG2D CAR T-cell therapy) Rochester, MN www.celyad.com

CPI-0610 Constellation Pharmaceuticals myelodysplastic syndromes, Phase I(BET inhibitor) Cambridge, MA myeloproliferative disorders www.constellationpharma.com

(see also leukemia, lymphoma, myeloma)

DCR-MYC Dicerna Pharmaceuticals hematological malignancies Phase I(c-myc inhibitor) Watertown, MA (see also liver) www.dicerna.com

duvelisib AbbVie advanced hematological malignancies Phase I(PI3K inhibitor) North Chicago, IL (see also leukemia, lymphoma) www.abbvie.com

Infinity Pharmaceuticals www.infi.comCambridge, MA

E6201 Strategia Therapeutics hematological malignancies Phase I/II(MEK-1/Flt3 dual inhibitor) Boston, MA www.strategiarx.com

entospletinib Gilead Sciences hematological malignancies Phase II(Syk inhibitor) Foster City, CA www.gilead.com

evofosfamide (TH-302) EMD Serono hematological malignancies Phase I(hypoxia-activated prodrug) Rockland, MA (see also brain, lung, pancreatic, sarcoma, skin) www.emdserono.com

Threshold Pharmaceuticals www.thresholdpharm.comSouth San Francisco, CA

FF-10501 Strategia Therapeutics hematological malignancies Phase I/II(cell differentiation stimulant) Boston, MA www.strategiarx.com

FUJIFILM Pharmaceuticals USABoston, MA

glasdegib (PF-04449913) Pfizer myelodysplastic syndromes Phase II(SMO [smoothened] antagonist) New York, NY (see also leukemia) www.pfizer.com

http://www.celyad.com/http://www.constellationpharma.com/http://www.dicerna.com/http://www.abbvie.com/http://www.infi.com/http://www.strategiarx.com/http://www.gilead.com/http://www.emdserono.com/http://www.thresholdpharm.com/http://www.strategiarx.com/http://www.pfizer.com/http://www.pfizer.com/http://www.strategiarx.com/http://www.thresholdpharm.com/http://www.emdserono.com/http://www.gilead.com/http://www.strategiarx.com/http://www.infi.com/http://www.abbvie.com/http://www.dicerna.com/http://www.constellationpharma.com/http://www.celyad.com/


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GS-4059 Gilead Sciences B-cell malignancies Phase I(BTK inhibitor) Foster City, CA www.gilead.com

GS-9901 Gilead Sciences hematological malignancies Phase I(PI3K delta inhibitor) Foster City, CA www.gilead.com

HDM201 Novartis Pharmaceuticals hematological malignancies Phase I(tumor suppressor protein East Hanover, NJ (see also sarcoma, solid tumors) www.novartis.comp53 modulator)

HSC835 Novartis Pharmaceuticals hematological malignancies in single Phase II(stem cell therapy) East Hanover, NJ umbilical cord blood transplantation www.novartis.com

Ibrance® Pfizer hematological malignancies Phase I

palbociclib New York, NY (see also breast) www.pfizer.com

idasanutlin Genentech/Roche hematological malignancies Phase I(MDM2 antagonist) South San Francisco, CA (see also solid tumors) www.roche.com

imetelstat Janssen Research & Development myelofibrosis Phase IIRaritan, NJ www.janssenrnd.com

INCB40093 Incyte B-cell malignancies Phase I/II(PI3K-delta inhibitor) Wilmington, DE www.incyte.com

INCB52793 Incyte hematological malignancies Phase I/II(JAK1 inhibitor) Wilmington, DE www.incyte.com

INCB54329 Incyte hematological malignancies Phase I(BRD inhibitor) Wilmington, DE www.incyte.com

http://www.gilead.com/http://www.gilead.com/http://www.novartis.com/http://www.novartis.com/http://www.pfizer.com/http://www.gene.com/http://www.janssenrnd.com/http://www.incyte.com/http://www.incyte.com/http://www.incyte.com/http://www.incyte.com/http://www.incyte.com/http://www.incyte.com/http://www.janssenrnd.com/http://www.gene.com/http://www.pfizer.com/http://www.novartis.com/http://www.novartis.com/http://www.gilead.com/http://www.gilead.com/


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JNJ-64052781 Janssen Research & Development hematological malignancies Phase I(CD19 antigen modulator) Raritan, NJ www.janssenrnd.com

JTCR016 Juno Therapeutics myelodysplastic syndromes Phase I/II(T lymphocyte immunotherapy) Seattle, WA (see also leukemia) www.junotherapeutics.com

KB004 KaloBios Pharmaceuticals EphA3-positive hematological Phase II(EphA3 kinase inhibitor) South San Francisco, CA malignancies www.kalobios.com

KiroVAX-001 Kiromic hematological malignancies Phase I(dendritic cell vaccine) Houston, TX www.kiromic.com

luspatercept (ACE-536) Acceleron Pharma myelodysplastic syndromes Phase II(TGF-ß protein super family Cambridge, MA www.acceleronpharma.com

inhibitor) Celgene www.celgene.comOrphan Drug Summit, NJ

MEDI-551 + rituximab MedImmune hematological malignancies Phase I(anti-CD19 mAb/anti-CD20 mAb) Gaithersburg, MD www.medimmune.com

MK-8628 Merck hematological malignancies Phase II(BRD-2/3/4 inhibitor) Kenilworth, NJ www.merck.com

mocetinostat Mirati Therapeutics myelodysplastic syndromes Phase II(HDAC inhibitor) San Diego, CA (see also bladder, lymphoma) www.mirati.com

Orphan Drug

momelotinib Gilead Sciences myelofibrosis Phase III(JAK inhibitor) Foster City, CA (see also pancreatic) www.gilead.com

Orphan Drug

http://www.janssenrnd.com/http://www.junotherapeutics.com/http://www.kalobios.com/http://www.kiromic.com/http://www.acceleronpharma.com/http://www.celgene.com/http://www.medimmune.com/http://www.merck.com/http://www.mirati.com/http://www.mirati.com/http://www.merck.com/http://www.medimmune.com/http://www.celgene.com/http://www.acceleronpharma.com/http://www.kiromic.com/http://www.kalobios.com/http://www.junotherapeutics.com/http://www.janssenrnd.com/


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MRX34 Mirna Therapeutics hematological malignancies Phase I(liposome-encapsulated Austin, TX (see also liver) www.mirnarx.commiR-34 mimic)

NiCord® Gamida Cell hematological malignancies Phase I/IIcord blood stem cell therapy Jerusalem, Israel www.gamida-cell.com

Orphan Drug

Opdivo® Bristol-Myers Squibb hematological malignancies Phase Inivolumab Princeton, NJ (see also bladder, brain, colorectal, head/neck, kidney, www.bms.com

liver, lung, lymphoma, skin, solid tumors, stomach, other)

oprozomib Onyx Pharmaceuticals Waldenstrom's macroglobulinemia (monotherapy) Phase II(proteasome inhibitor) South San Francisco, CA (see also myeloma, solid tumors) www.onyx.comOrphan Drug

hematological malignancies Phase I(combination therapy) www.onyx.com

OTX015 Merck hematological malignancies Phase I(BET inhibitor) Kenilworth, NJ (see also solid tumors) ww.merck.com

OXi4503 OxiGENE myelodysplastic syndromes Phase I(vascular disrupting agent) South San Francisco, CA (see also leukemia) www.oxigene.com

PAC-1 Vanquish Oncology hematological malignancies Phase I

(procaspase activating compound-1) Champaign, IL (see also solid tumors) www.vanquishoncology.com

pacritinib Baxalta myelofibrosis (Fast Track) Phase III(JAK2/FLT3 dual inhibitor) Cambridge, MA (see also leukemia) www.Baxalta.com

http://www.mirnarx.com/http://www.gamida-cell.com/http://www.bms.com/http://www.onyx.com/http://www.onyx.com/http://www.oxigene.com/http://www.vanquishoncology.com/http://www.baxlata.com/http://www.baxlata.com/http://www.vanquishoncology.com/http://www.oxigene.com/http://www.onyx.com/http://www.onyx.com/http://www.bms.com/http://www.gamida-cell.com/http://www.mirnarx.com/


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PIM447 Novartis Pharmaceuticals myelodysplastic syndromes Phase I(proto oncogene protein c East Hanover, NJ (see also leukemia, myeloma) www.novartis.compim-1 inhibitor)

POL6326 Polyphor stem cell mobilization in hematological malignancies Phase I(CXCR4 receptor antagonist) Allschwil, Switzerland (see also breast) www.polyphor.com

pracinostat MEI Pharma myelodysplastic syndromes (1st-line), Phase II(HDAC inhibitor) San Diego, CA refractory myelodysplastic syndromes www.meipharma.com

(see also leukemia)

PRM-151 Promedior myelofibrosis (Fast Track) Phase II(rhPTX-1 for injection) Lexington, MA www.promedior.comOrphan Drug

Promacta® Novartis Pharmaceuticals myelodysplastic syndromes Phase IIeltrombopag East Hanover, NJ www.novartis.com

Revlimid® Celgene myelodysplastic syndromes (non-deletion 5q) Phase IIIlenalidomide Summit, NJ (see also leukemia, lymphoma, myeloma) www.celgene.com

Orphan Drug

rexlemestrocel-L Mesoblast for bone marrow regeneration in patients with Phase III(allogeneic autologous New York, NY hematological malignancies undergoing bone www.mesoblast.commesenchymal precursor cells) marrow transplantation

Orphan Drug

http://www.novartis.com/http://www.polyphor.com/http://www.meipharma.com/http://www.promedior.com/http://www.novartis.com/http://www.celgene.com/http://www.mesoblast.com/http://www.mesoblast.com/http://www.celgene.com/http://www.novartis.com/http://www.promedior.com/http://www.meipharma.com/http://www.polyphor.com/http://www.novartis.com/


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rigosertib Onconova Therapeutics post-HMR high-risk myelodysplastic syndromes Phase III(PI3K/Plk1 inhibitor) Newtown, PA (see also leukemia) www.onconova.com

Orphan Drug

high-risk myelodysplastic syndromes Phase II(1st-line) (combination therapy), www.onconova.comlow-risk myelodysplastic syndromes (1st-line)

RP-323 Rich Pharmaceuticals myelodysplastic syndromes Phase II(tetradecanoylphorbol acetate) Beverly Hills, CA (see also leukemia) www.richpharmaceuticals.com

sapacitabine Cyclacel Pharmaceuticals myelodysplastic syndromes Phase II(DNA-directed DNA polymerase Berkeley Heights, NJ (see also leukemia, lung) www.cyclacel.cominhibitor)

Orphan Drug

selinexor (oral) Karyopharm Therapeutics Richter's transformation Phase III(XPO1 antagonist) Newton, MA (see also brain, head/neck, leukemia, lymphoma, www.karyopharm.com

myeloma, prostate, sarcoma, other)

SGI-110 Astex Pharmaceuticals myelodysplastic syndromes Phase II(DNMT inhibitor) Pleasanton, CA (see also leukemia, liver, ovarian) www.astx.com

SL-401 Stemline Therapeutics blastic plasmacytoid dendritic cell neoplasm, Phase I/II(IL-3R inhibitor) New York, NY advanced high risk myeloproliferative neoplasm www.stemline.com

(see also leukemia)

StemEx® Gamida Cell-Teva Joint Venture hematological malignancies Phase IIIcarlecortemcel-L Jerusalem, Israel (Fast Track) www.gamida-cell.com

TAK-659 Takeda Oncology hematological malignancies Phase I(SYK kinase inhibitor) Cambridge, MA (see also solid tumors) www.takedaoncology.com

http://www.onconova.com/http://www.onconova.com/http://www.richpharmaceuticals.com/http://www.cyclacel.com/http://www.karyopharm.com/http://www.astx.com/http://www.stemline.com/http://www.gamida-cell.com/http://www.takedaoncology.com/http://www.takedaoncology.com/http://www.gamida-cell.com/http://www.stemline.com/http://www.astx.com/http://www.karyopharm.com/http://www.cyclacel.com/http://www.richpharmaceuticals.com/http://www.onconova.com/http://www.onconova.com/


35/146



TEN-010 Tensha Therapeutics myelodysplastic syndromes Phase I(BET inhibitor) Cambridge, MA (see also leukemia, solid tumors) www.tenshatherapeutics.com

TGR-1202 TG Therapeutics hematological malignancies Phase I(PI3K inhibitor) New York, NY www.tgtherapeutics.com

tosedostat CTI BioPharma myelodysplastic syndromes Phase II(aminopeptidase inhibitor) Seattle, WA (see also leukemia) www.ctibiopharma.com

TZ101 Targazyme cord blood stem cell transplantation Phase I/II(human recombinant enzyme) San Antonio, TX in hematological malignancies www.targazyme.com

ulocuplumab Bristol-Myers Squibb hematological malignancies Phase I(anti-CXCR4) Princeton, NJ www.bms.com

urelumab Bristol-Myers Squibb hematological malignancies Phase IPrinceton, NJ (see also solid tumors) www.bms.com

urelumab + Bristol-Myers Squibb hematological malignancies Phase IOpdivo® nivolumab Princeton, NJ (see also solid tumors) www.bms.com

varlilumab Celldex Therapeutics hematological malignancies Phase I(CD27 antigen inhibitor) Hampton, NJ (see also kidney, skin) www.celldex.com

venetoclax AbbVie hematological malignancies Phase I(Bcl-2 inhibitor) North Chicago, IL (see also leukemia, lymphoma) www.abbvie.com

Genentech/Roche www.roche.comSouth San Francisco, CA

WT-1 cancer vaccine SELLAS Life Sciences hematological malignancies Phase II Zug, Switzerland www.sellaslifesciences.com

http://www.tenshatherapeutics.com/http://www.tgtherapeutics.com/http://www.ctibiopharma.com/http://www.targazyme.com/http://www.bms.com/http://www.bms.com/http://www.bms.com/http://www.celldex.com/http://www.abbvie.com/http://www.gene.com/http://www.sellaslifesciences.com/http://www.sellaslifesciences.com/http://www.gene.com/http://www.abbvie.com/http://www.celldex.com/http://www.bms.com/http://www.bms.com/http://www.bms.com/http://www.targazyme.com/http://www.ctibiopharma.com/http://www.tgtherapeutics.com/http://www.tenshatherapeutics.com/


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WT2725 Sunovion Pharmaceuticals hematological malignancies Phase I(cancer immunotherapy) Marlborough, MA (see also solid tumors) www.sunovion.com

Kidney Cancer


AGS-003 Argos Therapeutics metastatic renal cell carcinoma Phase III(personalized dendritic Durham, NC (combination therapy) (Fast Track) www.argostherapeutics.comcell-based vaccine)

metastatic renal cell carcinoma Phase II(monotherapy) www.argostherapeutics.com

AGS-16C3F Agensys kidney cancer Phase I

(antibody drug conjugate) Santa Monica, CA www.agensys.comAstellas Pharma www.astellas.com

Tokyo, Japan

AMG 172 Amgen kidney cancer Phase I(antibody drug conjugate) Thousand Oaks, CA www.amgen.com

Archexin® Rexahn Pharmaceuticals metastatic renal cell carcinoma Phase IIAkt1 inhibitor Rockville, MD www.rexahn.comOrphan Drug

BNC105 Bionomics renal cell carcinoma Phase II(vascular disrupting agent) Thebarton, Australia (see also ovarian) www.bionomics.com.au

Cometriq® Exelixis renal cell carcinoma (Fast Track) Phase IIIcabozantinib South San Francisco, CA (see also brain, liver) www.exelixis.com

http://www.sunovion.com/http://www.argostherapeutics.com/http://www.argostherapeutics.com/http://www.agensys.com/http://www.astellas.com/http://www.amgen.com/http://www.rexahn.com/http://www.bionomics.com.au/http://www.exelixis.com/http://www.exelixis.com/http://www.bionomics.com.au/http://www.rexahn.com/http://www.amgen.com/http://www.astellas.com/http://www.agensys.com/http://www.argostherapeutics.com/http://www.argostherapeutics.com/http://www.sunovion.com/


37/146

Kidney Cancer


CRLX101 Cerulean Pharma relapsed renal cell carcinoma Phase II(nanoparticle drug conjugate) Cambridge, MA (see also colorectal, ovarian) www.ceruleanrx.com

dalantercept Acceleron Pharma renal cell carcinoma Phase II(ALK1 antagonist) Cambridge, MA (see also liver) www.acceleronpharma.com

HyperAcute™ Renal NewLink Genetics metastatic renal cancer Phase Irenal cancer immunotherapy vaccine Ames, IA www.newlinkgenetics.com

IMA901 immatics Biotechnologies renal cancer Phase III(multiple tumor-associated Tuebingen, Germany www.immatics.compeptides)

Inlyta® Pfizer renal cell carcinoma Phase III

axitinib New York, NY (see also solid tumors) www.pfizer.comOrphan Drug

Lenvima® Eisai renal cell carcinoma Phase I/IIlenvatinib Woodcliff Lake, NJ (see also liver, lung, skin, other, solid tumors) www.eisai.com

LY2510924 Eli Lilly clear-cell renal cell carcinoma Phase II(CXCR4 peptide antagonist) Indianapolis, IN (see also lung) www.lilly.com

Nexavar® Bayer HealthCare Pharmaceuticals renal cell carcinoma (adjuvant) Phase IIIsorafenib Whippany, NJ (see also other) www.healthcare.bayer.com

OBP-801 Oncolys BioPharma recurrent renal cancer Phase I(HDAC inhibitor) Tokyo, Japan www.oncolys.com

Opdivo® Bristol-Myers Squibb renal cell carcinoma (2nd/3rd-line) Phase IIInivolumab Princeton, NJ (see also bladder, brain, colorectal, head/neck, www.bms.com

hematological, liver, lung, lymphoma, skin,

solid tumors, stomach, other)

http://www.ceruleanrx.com/http://www.acceleronpharma.com/http://www.newlinkgenetics.com/http://www.immatics.com/http://www.pfizer.com/http://www.eisai.com/http://www.lilly.com/http://www.oncolys.com/http://www.bms.com/http://www.bms.com/http://www.oncolys.com/http://www.lilly.com/http://www.eisai.com/http://www.pfizer.com/http://www.immatics.com/http://www.newlinkgenetics.com/http://www.acceleronpharma.com/http://www.ceruleanrx.com/


38/146

Kidney Cancer


Opdivo® nivolumab + Bristol-Myers Squibb renal cell carcinoma (1st-line) Phase IIIYervoy® ipilimumab Princeton, NJ (see also lung, skin, solid tumors) www.bms.com

pexastimogene devacirepvec SillaJen Biotherapeutics treatment refractory kidney cancer Phase II(genetically-engineered oncolytic San Francisco, CA (see also liver) www.sillajen.comvaccinia virus)

PT-2385 Peloton Therapeutics clear cell renal cell carcinoma Phase I(HIF-2α inhibitor) Dallas, TX www.pelotontherapeutics.com

RG7446 Genentech/Roche renal cell carcinoma Phase III(anti-PD-L1 mAb) South San Francisco, CA (see also bladder, breast, lung, lymphoma, skin) www.roche.com

savolitinib/volitinib AstraZeneca papillary renal cell carcinoma Phase II

(MET tyrosine kinase inhibitor) Wilmington, DE www.astrazeneca.com

SGN-CD70A Seattle Genetics renal cell carcinoma Phase I(antibody drug conjugate) Bothell, WA (see also lymphoma) www.seattlegenetics.com

sonepcizumab Lpath renal cell carcinoma Phase II(anti-sphingosine-1-phosphate San Diego, CA www.lpath.commAb)

Stivarga® Bayer HealthCare Pharmaceuticals renal cell carcinoma Phase IIregorafenib Whippany, NJ (see also colorectal, liver) www.healthcare.bayer.com

Sutent® Pfizer renal cell carcinoma (adjuvant) Phase IIIsunitinib New York, NY www.pfizer.com

TAK-228 Takeda Oncology renal cancer Phase II(mTORC1/2 inhibitor) Cambridge, MA (see also breast, other) www.takedaoncology.com

http://www.bms.com/http://www.sillajen.com/http://www.pelotontherapeutics.com/http://www.gene.com/http://www.astrazeneca.com/http://www.seattlegenetics.com/http://www.lpath.com/http://www.pfizer.com/http://www.takedaoncology.com/http://www.takedaoncology.com/http://www.pfizer.com/http://www.lpath.com/http://www.seattlegenetics.com/http://www.astrazeneca.com/http://www.gene.com/http://www.pelotontherapeutics.com/http://www.sillajen.com/http://www.bms.com/


39/146

Kidney Cancer


TRC105 TRACON Pharmaceuticals renal cell carcinoma Phase II(END protein inhibitor) San Diego, CA (see also brain, breast, colorectal, liver, lung, www.traconpharma.com

sarcoma, other)

TVI-Kidney-1 TVAX Biomedical kidney cancer Phase II(personalized cancer Lenexa, KS (see also brain) www.tvaxbiomedical.comimmunotherapy)

varlilumab Celldex Therapeutics metastatic clear cell renal cell carcinoma Phase I/II(CD27 antigen inhibitor) Hampton, NJ (combination therapy) www.celldex.com

(see also hematological, skin)

Votrient® Novartis Pharmaceuticals renal cell carcinoma (adjuvant) Phase IIIpazopanib East Hanover, NJ www.novartis.com

Leukemia


Å6 peptide Angstrom Pharmaceuticals chronic lymphocytic leukemia (CLL), Phase II(CD44 antigen stimulant) Solana Beach, CA small lymphocytic leukemia www.angstrominc.com

ABL001 Novartis Pharmaceuticals chromic myeloid leukemia (CML) Phase I(Bcr-abl tyrosine kinase inhibitor) East Hanover, NJ www.novartis.com

http://www.traconpharma.com/http://www.tvaxbiomedical.com/http://www.celldex.com/http://www.novartis.com/http://www.angstrominc.com/http://www.novartis.com/http://www.novartis.com/http://www.angstrominc.com/http://www.novartis.com/http://www.celldex.com/http://www.tvaxbiomedical.com/http://www.traconpharma.com/


40/146

Leukemia


ACP-196 Acerta Pharma CLL Phase III(Btk inhibitor) San Carlos, CA (see also bladder, head/neck, hematological, www.acerta-pharma.com

lung, lymphoma, myeloma, pancreatic)

relapsed/refractory and treatment naïve Phase IIdeletion 17p CLL www.acerta-pharma.com

CLL (combination therapy) Phase Iwww.acerta-pharma.com

ACP-319 Acerta Pharma CLL (combination therapy) Phase I/II(Btk inhibitor) San Carlos, CA (see also lymphoma) www.acerta-pharma.com

AG-120 Agios Pharmaceuticals acute myeloid leukemia (AML) Phase I

(IDH1 inhibitor) Cambridge, MA (see also brain, solid tumors) www.agios.comCelgene www.celgene.comSummit, NJ

AG-221 Agios Pharmaceuticals AML Phase I(IDH2 inhibitor) Cambridge, MA (see also solid tumors) www.agios.com

Orphan Drug Celgene www.celgene.com

Summit, NJ

alvocidib Tolero Pharmaceuticals AML (1st-line) Phase III(angiogenesis inhibitor) Lehi, UT www.toleropharmaceuticals.comOrphan Drug

relapsed/refractory AML Phase IIwww.toleropharmaceuticals.com

AMG 232 Amgen AML Phase I(MDM2 inhibitor) Thousand Oaks, CA (see also myeloma, skin, solid tumors) www.amgen.com

http://www.acerta-pharma.com/http://www.acerta-pharma.com/http://www.acerta-pharma.com/http://www.acerta-pharma.com/http://www.agios.com/http://www.celgene.com/http://www.agios.com/http://www.celgene.com/http://www.toleropharmaceuticals.com/http://www.toleropharmaceuticals.com/http://www.amgen.com/http://www.amgen.com/http://www.toleropharmaceuticals.com/http://www.toleropharmaceuticals.com/http://www.celgene.com/http://www.agios.com/http://www.celgene.com/http://www.agios.com/http://www.acerta-pharma.com/http://www.acerta-pharma.com/http://www.acerta-pharma.com/http://www.acerta-pharma.com/


41/146

Leukemia


Arzerra® Novartis Pharmaceuticals CLL (maintenance therapy), CLL (relapse) Phase IIIofatumumab East Hanover, NJ (see also lymphoma) www.novartis.comOrphan Drug

ASP2215 Astellas Pharma US AML Phase III(FLT3/AXL inhibitor) Northbrook, IL (see also lung) www.astellas.com

AST-VAC1 Asterias Biotherapeutics AML Phase II completed(telomerase-based cancer vaccine) Menlo Park, CA www.asterias.com

ATTCK20 Unum Therapeutics CLL Phase I(viral-ACTR+anti-CD20) Cambridge, MA (see also lymphoma) www.unumrx.com

BAY1143572 Bayer HealthCare Pharmaceuticals acute leukemia Phase I

Whippany, NJ (see also other) www.healthcare.bayer.com

BB-MPI-03 Benovus Bio AML Phase I(multi-peptide immunotherapy) Atlanta, GA (see also hematological, myeloma) www.benovusbio.com

bendamustine ready-to-dilute Eagle Pharmaceuticals CLL application submittedliquid formulation Woodcliff Lake, NJ (see also lymphoma, solid tumors) www.eagleus.com

Orphan Drug

BI 836826 Boehringer Ingelheim Pharmaceuticals CLL Phase IRidgefield, CT www.boehringer-ingelheim.com

BI 836858 Boehringer Ingelheim Pharmaceuticals relapsed/refractory AML Phase IRidgefield, CT (see also hematological) www.boehringer-ingelheim.com

BL-8040 BioLineRx AML (combination therapy) Phase II(CXCR4 receptor antagonist) Jerusalem, Israel www.biolinerx.comOrphan Drug

http://www.novartis.com/http://www.astellas.com/http://www.asterias.com/http://www.unumrx.com/http://www.benovusbio.com/http://www.eagleus.com/http://www.boehringer-ingelheim.com/http://www.boehringer-ingelheim.com/http://www.biolinerx.com/http://www.biolinerx.com/http://www.boehringer-ingelheim.com/http://www.boehringer-ingelheim.com/http://www.eagleus.com/http://www.benovusbio.com/http://www.unumrx.com/http://www.asterias.com/http://www.astellas.com/http://www.novartis.com/


42/146

Leukemia


Blincyto® Amgen relapsed/refractory acute lymphoblastic Phase IIIblinatumomab Thousand Oaks, CA leukemia (ALL) in adults www.amgen.com

(see also lymphoma)

relapsed/refractory Philadelphia Phase IIchromosome positive (Ph+) ALL in adults, www.amgen.comminimal residual ALL in adults

Bosulif® Pfizer chronic myeloid leukemia (CML) (1st-line) Phase IIIbosutinib New York, NY www.pfizer.comOrphan Drug

BP-100-1-01 Bio-Path Holdings AML Phase II(liposomal Grb 2) Houston, TX (see also hematological) www.biopathholdings.com

Orphan Drug

ALL, CML Phase Iwww.biopathholdings.com

BVD-523 BioMed Valley Discoveries AML Phase I/II(ERK 1/2 kinase inhibitor) Kansas City, MO (see also hematological, solid tumors) www.biomed-valley.com

calaspargase pegol Baxalta ALL Phase III

Orphan Drug Cambridge, MA www.baxalta.com

CC-122 Celgene CLL Phase I

(pleiotropic pathway modifier) Summit, NJ (see also brain, liver, lymphoma) www.celgene.com

CC-292 Celgene CLL (combination therapy) Phase I(Btk inhibitor) Summit, NJ (see also lymphoma) www.celgene.com

CC-486 Celgene post-induction AML maintenance Phase III(DNA methylation inhibitor) Summit, NJ (see also breast, hematological, lung, www.celgene.com

lymphoma, other)

http://www.amgen.com/http://www.amgen.com/http://www.pfizer.com/http://www.biopathholdings.com/http://www.biopathholdings.com/http://www.biomed-valley.com/http://www.baxalta.com/http://www.celgene.com/http://www.celgene.com/http://www.celgene.com/http://www.celgene.com/http://www.celgene.com/http://www.celgene.com/http://www.baxalta.com/http://www.biomed-valley.com/http://www.biopathholdings.com/http://www.biopathholdings.com/http://www.pfizer.com/http://www.amgen.com/http://www.amgen.com/


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Leukemia


cerdulatinib Portola Pharmaceuticals CLL Phase II(dual Syk-JAK inhibitor) South San Francisco, CA (see also lymphoma) www.portola.com

CNDO-109 Fortress Biotech AML Phase I/II(natural killer cell stimulant) New York, NY www.fortressbiotech.com

Orphan Drug

CPI-0610 Constellation Pharmaceuticals leukemia Phase I(BET inhibitor) Cambridge, MA (see also hematological, lymphoma, myeloma) www.constellationpharma.com

CPX-351 Celator Pharmaceuticals acute AML (Fast Track) Phase II(cytarabine/daunorubicin) Ewing, NJ www.celatorpharma.com

Orphan Drug

crenolanib AROG Pharmaceuticals relapsed/refractory AML Phase III(PDGFR inhibitor) Dallas, TX (see also brain, lung, stomach) www.arogpharma.com

newly-diagnosed AML, maintenance therapy Phase IIafter bone marrow transplantation in AML www.arogpharma.com

AML (combination therapy) Phase Iwww.arogpharma.com

CTL019 Novartis Pharmaceuticals ALL (Breakthrough Therapy) Phase II(CAR immunotherapy) East Hanover, NJ (see also lymphoma) www.novartis.com

CWP232291 JW Pharmaceutical AML Phase I(Wnt signaling pathway inhibitor) Seoul, South Korea

CX-01 Cantex Pharmaceuticals AML Phase II(O-desulfated heparin intravenous) Weston, FL (see also lung, solid tumors) www.cantex.com

http://www.portola.com/http://www.fortressbiotech.com/http://www.constellationpharma.com/http://www.celatorpharma.com/http://www.arogpharma.com/http://www.arogpharma.com/http://www.arogpharma.com/http://www.novartis.com/http://www.cantex.com/http://www.cantex.com/http://www.novartis.com/http://www.arogpharma.com/http://www.arogpharma.com/http://www.arogpharma.com/http://www.celatorpharma.com/http://www.constellationpharma.com/http://www.fortressbiotech.com/http://www.portola.com/


44/146

Leukemia


DFP-10917 Delta-Fly Pharma ALL, AML Phase I/II(cell cycle inhibitor) Tokushima, Japan

duvelisib AbbVie relapsed/refractory CLL Phase III(PI3K inhibitor) North Chicago, IL (see also hematological, lymphoma) www.abbvie.com

Orphan Drug Infinity Pharmaceuticals www.infi.com

Cambridge, MA

relapsed/refractory CLL previously Phase Itreated with a BTK inhibitor therapy www.abbvie.com

www.infi.com

EPZ-5676 Celgene ALL and AML with altered MLL gene Phase I(DOT1L inhibitor) Summit, NJ www.celgene.comOrphan Drug Epizyme www.epizyme.com

Cambridge, MA

ERY-ASP ERYTECH Pharma ALL (adults) Phase I/II(asparaginase pegol) Lyon, France w

Documents

2015_cancer_drug_list.pdf