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Mark Frohlich, MD, SVP and Chief Medical Officer
September 25, 2008 Washington, DC
4th Annual African American Prostate Cancer Disparity Summit
P. 24th Annual African American Prostate Cancer Disparity Summit
Time
Death
The Prostate Cancer EpidemicTreatment Continuum
Metastatic
Tumor volume
& activity
Castration
Chemotherapy
LocalTherapy
Non-Metastatic
SymptomaticAsymptomatic
Androgen Dependent Androgen Independent
P. 34th Annual African American Prostate Cancer Disparity Summit
The Prostate Cancer Epidemic:Current Standard of Care
Administration Q 3 Weeks x 10 via infusion
Efficacy 2.4 Month median survival AdvantageHR= 1.32P=.009
Safety:
Grade 3/4
Event Rate
Hair Loss 65%Fatigue 53%Nausea/Vomiting 42%Diarrhea 32%Neutropenia 32%Nail Changes 30%Neuropathy 30%Stomatitis 20%Peripheral Edema 19%Change in Taste 18%Anorexia 17%Dyspnea 15%
Source: Taxotere label
Docetaxel
P. 44th Annual African American Prostate Cancer Disparity Summit
The Prostate Cancer Epidemic: Patient Dissatisfaction
Source: USTOO Survey Press Release, September 8, 2005; 2006 Prostate Cancer Symposia Poster #222
65%
52%
0%
20%
40%
60%
80%
100%
Would Consider Chemotherapy
Impact on QOL Outweighs Benefit
Advanced Prostate Cancer Patients
“Men with late-stage disease need more options. These men and their families shouldn’t have to compromise their quality of lives. We need better treatments that fight this disease, address the most painful symptoms, and lessen the side effects of treatment.”
-Thomas Kirk, president and CEO of Us Too International
P. 54th Annual African American Prostate Cancer Disparity Summit
Dendreon
» Product Focus: Oncology
» Lead Product: PROVENGE® (sipuleucel-T)
» Headquarters: Seattle
» Commercial Manufacturing: Morris Plains, NJ
» Founded: 1992
» Employees: ~200
Ray -- Prostate Cancer Survivor and PROVENGE Study Patient
Survival is what matters
P. 64th Annual African American Prostate Cancer Disparity Summit
What is Provenge?
» Provenge is an investigational Active Cellular Immunotherapy (ACI)
» ACIs are a new class of drug, often referred to as “therapeutic cancer vaccines”
» ACIs are very different from traditional vaccines
Traditional Vaccines:
PREVENT disease by, e.g., exposing the immune system to weakened virus or portion of a virus
Therapeutic Cancer Vaccine/ ACIs:
TREAT disease by using the body’s immune system to fight the cancer
Immunotherapies are designed to be specific, affecting only cancer cells.
P. 74th Annual African American Prostate Cancer Disparity Summit
Targeting Tumor Cells and Mounting a Strong Anti-Cancer Response
APC takes up the antigen
Recombinant Prostatic Acid Phosphatase
(PAP) antigen combines with resting antigen presenting cell
(APC)
Fully activated, the APC is now sipuleucel-T
The precise mechanism of sipuleucel-T in prostate cancer has not been established.
Antigen is processed and presented on
surface of the APCINFUSE PATIENT
T-cells proliferate and attack cancer cells
Sipuleucel-T activates T-cells
in the body
Active T-cell
Inactive T-cell
P. 84th Annual African American Prostate Cancer Disparity Summit
Active Cellular Immunotherapy:Production and Delivery
• Convenient for both physician and patient
• Complete course of therapy is one month
P. 94th Annual African American Prostate Cancer Disparity Summit
PROVENGE Study D9901: Increased SurvivalPhase 3 Study in Androgen-Independent PCa
0 6 12 18 24 30 36
0
25
50
75
100 sipuleucel-T (n=82)placebo (n=45)
p = 0.010 (log rank)HR = 1.71 [95% CI: 1.13, 2.58]
34%
11%
Median benefit4.5 months
Months
Pro
bab
ility
of S
urv
ivin
g
P. 104th Annual African American Prostate Cancer Disparity Summit
Provenge Safety Profile
» Most frequent events associated with product infusion
» Chills
» Fever
» Adverse drug reactions
» Generally mild to moderate in severity
» Majority resolved within 24 hours
» < 3% of patients unable to receive all 3 infusions due to treatment-related adverse events
P. 114th Annual African American Prostate Cancer Disparity Summit
Regulatory Timeline
» Dendreon completes license application November 2006
» Positive FDA Advisory Panel Meeting March 2007
» FDA requests additional clinical data May 2007
P. 124th Annual African American Prostate Cancer Disparity Summit
IMPACT Phase 3 Study (D9902B)IMmunotherapy for Prostate AdenoCarcinoma Treatment
Asymptomatic or minimally
symptomatic Metastatic Androgen Independent Prostate
Cancer (n=~500)Placebo
Q 2 weeks x 3
Provenge Q 2 weeks x 3
P R O
G R E S
S I O N
PB01 (Salvage) Q 2
weeks x 3
Treated at MD
discretion
2:1 Followed for survival
Primary endpoint: Overall Survival Secondary endpoint: Time to Disease Progression
P. 134th Annual African American Prostate Cancer Disparity Summit
Regulatory Timeline
» Dendreon completes license application November 2006
» Positive FDA Advisory Panel Meeting March 2007
» FDA requests additional clinical data May 2007
» Confirmatory IMPACT study fully enrolled November 2007
» FDA agrees that either a positive interim or final analysis for survival from the IMPACT study would be sufficient to meet request for additional clinical information to support efficacy claim
» Interim results from IMPACT study in October 2008; final results in 2009
P. 144th Annual African American Prostate Cancer Disparity Summit
Time
Death
Provenge: Addressing an Unmet Need
Metastatic
Tumor volume
& activity
Castration
Chemotherapy
LocalTherapy
Non-Metastatic
SymptomaticAsymptomatic
Androgen Dependent Androgen Independent
Provenge
P. 154th Annual African American Prostate Cancer Disparity Summit
Ongoing PROVENGE Clinical Studies
» Neoadjuvant Trial (n=40, single site study, open for enrollment)
» Assess safety and immune response of PROVENGE prior to radical prostatectomy
» Immune response to PROVENGE will be assessed in the prostatectomy specimen and in the peripheral blood
» All patients will be scheduled to receive active treatment
» PRO-ACT Trial (n=120, multicenter study, open for enrollment)
» P07-2 PRO-ACT (PROstate Active Cellular Therapy) study has essentially the same enrollment criteria as the IMPACT study
» Patients receive PROVENGE made with differing concentrations of immunizing antigen
» All patients in the trial will receive active treatment
P. 164th Annual African American Prostate Cancer Disparity Summit
Case Study
» 83 years old
»Diagnosis of metastatic HRPC in 2001
» 5 years from receiving treatment
Eduardo -- Prostate Cancer Survivor and Sipuleucel-T Study D9901 Patient
P. 174th Annual African American Prostate Cancer Disparity Summit
Survival is the ultimate goal in cancer treatment…
Improving survival for people with cancer is a goal worth fighting for.