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NEW PERSPECTIVES: A Multidisciplinary Approach To Managing Advanced Prostate Cancer

PRESS BRIEFINGSunday, March 20, 201109:00 – 11:00AM

COM.CAB.11.03.03 03/2011

This slide deck is being provided in response to an unsolicited request and is intended

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COM.CAB.11.03.03 03/2011

Disclosures

•

This press briefing is sponsored by sanofi-aventis, a premier sponsor of the EAU Congress Vienna.

•

Cabazitaxel has been filed with the EMA, but no marketing

authorization has yet been granted. Cabazitaxel

is currently

approved in the United States, Brazil, Curaçao, and Israel and

is marketed under the trade name

JEVTANA®.

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COM.CAB.11.03.03 03/2011

Press Briefing Agenda

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9:00 –

9:05 AM –

Welcome/Introduction of Panel

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9:05 –

9:25 AM –

The MDT Approach to Improving Survival in Prostate Cancer

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9:25 –

9:40 AM –

Highlights of TROPIC Study

•

9:40 –

9:55 AM –

Assessing Patient Eligibility for Cabazitaxel

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9:55 –

10:00 AM –

Final Points

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10:00 –

10:15 AM – Questions from the Media

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10:15 –

10:20 AM –

Closing Remarks

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10:20 –

11:00 AM –

Interviews with Panelists

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Panelist Introductions

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Bernard Peyrical, Head of Region Europe Communications, sanofi-

aventis

•

Amit Bahl, Consultant Oncologist, Head of Research, Head of Radiotherapy, Bristol Haematology and Oncology Centre, University Hospitals Bristol, UK

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Stéphane Oudard, M.D., Ph.D., Professor of Oncology and Chief of the Oncology Translational Research Unit at the Georges Pompidou

Hospital, Paris, France

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The MDT Approach to Improving Survival in Prostate Cancer

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Dr. Amit BahlDr. Stéphane Oudard


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Prostate Cancer Overview

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Prostate cancer is the second-most common cancer in men (worldwide) and the third leading cause of cancer death (in developed countries)1,2

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Established risk factors include3:

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Age: the median age at diagnosis is 68 years

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Race: African American men have the highest incidence rates

•

Family history

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10% to 20% of patients present with metastatic disease at diagnosis6

1. Nelen V. Recent Results Cancer Res. 2007;175:1-8.2. American Cancer Society. Global Cancer Facts & Figures 2007. Atlanta: American Cancer Society; 2007.3. American Cancer Society. Cancer Facts & Figures 2010. Atlanta: American Cancer Society; 2010.4. Ferlay J, Parkin DM, Steliarova-Foucher E. Eur J Cancer. 2010;46(4):765-781.5. International Agency for Research on Cancer. GLOBOCAN 2002 Database. http://www-dep.iarc.fr/.Accessed March 10, 2010.6. Tannock IF, de Wit R, Berry WR, et al. N Engl J Med. 2004;351(15):1502-1512.


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Treatment Options for Prostate Cancer

No cancer

Localised disease

Rising PSA

after local therapy

Metastatic hormone sensitive

Metastatic hormone resistant

Curative therapy°

Active surveillance

Hormonal treatment

Chemotherapy

Clinical trials

°Radical prostatectomy or external beam radiation

therapy or brachytherapy


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Treatment of Advanced Prostate Cancer

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The cornerstone treatment for advanced prostate cancer is androgen deprivation therapy (ADT)

–

Objective response > 80% of patients but with time

the cancer will become resistant to hormone therapy (Hormone Refractory Prostate cancer -

HRPC)

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Once a patient with metastatic prostate cancer fails androgen deprivation therapy, chemotherapy with docetaxel has become a standard1-4

–

To delay disease progression–

To prolong survival–

To improve QOL

1Heidenreich A, et al. (2010 update) www.uroweb.org 2Mohler J, et al. (2009 update) www.nccn.org 3Basch EM, et al. J Clin Oncol 2007;25:5313–18 4Horwich A, et al. Ann Oncol 2009;20(Suppl 4):76–8


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COM.CAB.11.03.03 03/2011

Prostate Cancer: Management

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Earlier diagnosis means more “curable”

disease

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80% of ‘high risk’

prostate cancer will develop biochemical relapse or clinical failure within 10 years1

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High risk and advanced or metastatic disease require:–

Multiple systemic therapies –

Ideally within the multi-disciplinary team approach

1D’Amico. JCO 2003, 21, 2163

.


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COM.CAB.11.03.03 03/2011

Multidisciplinary Teams in Prostate Cancer: Patient-Centric Management

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The Extended Team Supports the Patient

Support staffSpecialist nurse

DieticianPhysiotherapist

Palliative care specialist

Supporting physiciansPain management

NeurosurgeonPsychiatrist

Primary care physician

Patient

Treating physiciansUrologist

Medical oncologistRadiation oncologist

Onco-geriatrician

Clinical and fundamental

research teams

Diagnostic managementRadiologistPathologist


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COM.CAB.11.03.03 03/2011

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As the role of chemotherapy for the treatment of HRPC evolves, the need for strong partnerships between urologists and oncologists increases1

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Optimal patient management should involve close coordination between urologists and oncologists to ensure that all appropriate, and potentially beneficial, treatment options are explored1

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Only about 30% of patients with mHRPC are referred for chemotherapy by their urologist2

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Increased Collaboration Between Urologists and Oncologists

1. Kibel AS. Urology 2005; 65 (Suppl): 13–18.2. Crawford ED. Rev Urol 2003; 5 (Suppl 2): S48–52.


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Patient Benefits of MDT Approach in Prostate Cancer Care

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Mutual alignment of expectations and treatment goals among urologists, oncologists, and patients can improve patient care.1

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“Patients managed by teams which function effectively are more likely to be offered appropriate information and guidance, to receive continuity of care through all stages of their disease, and to be treated in accordance with locally agreed protocols and clinical guidelines”2

1. Gomella LG, Lin J, Hoffman-Censits J, et al. Enhancing prostate cancer care through the multidisciplinary clinic approach: a 15-year experience. J Clin Pract. 2010;6(6):e5-e10.

2. NICE. The Manual. 2002


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Patient Benefits of MDT Approach in Prostate Cancer Care

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•

Core team members provide expert multidimensional approach to identifying disease progression and moving patients towards more

effective therapies as soon as possible.1

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MDTs encourage men to receive supportive care, rehabilitation and emotional support, all of which are important in the treatment of advanced prostate cancer.1

1. Valdagni R, Albers P, Bangma C, et al. “The Requirements of a specialist Prostate Cancer Unit: a discussion paper from the European School of Oncology. Eur J Cancer. 2011 Jan;47(1):1-7.


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MDT Approach Influences Diagnostic and Treatment Decisions

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296 patients presented MDT with an outside diagnosis of a urologic malignancy

Kurpad R, et al. Urol Oncol 2009 [Epub ahead]of print]

Dx = diagnostic decision. Tx = treatment decision

34.6%

23.4%

5.6%

8.9%

10.4%

17.1%

0.0% 10.0% 20.0% 30.0% 40.0%

No change in Dx or Tx

No change Dx/change Tx

Change in Dx/no change in Tx

Change in Dx and Tx

Other

N/A 38% change in

diagnostic

decision or

treatment

38% change in

diagnostic

decision or

treatment


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COM.CAB.11.03.03 03/2011

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Multidisciplinary Teams in Prostate Cancer: NICE Guidance: improving outcomes

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All patients with urological cancer –

both newly diagnosed and existing –

should be managed by appropriate MDTs1

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The MDT can comprise of: lead clinician; urologist; specialist nurse; radiologist; pathologist; oncologist; and palliative care specialist1

1. NICE. The Manual. 2002


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COM.CAB.11.03.03 03/2011

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7 OUT OF 10This slide deck is being provided in response to an unsolicited request and is intended

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COM.CAB.11.03.03 03/2011

Practical example: European Hospital Georges Pompidou

‘Prendre Soin’ (Taking Care)

Stephane Oudard


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Supportive Care in Cancer

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Supportive care is the prevention and management of the adverse effects of cancer and its treatment across the entire continuum of a patient’s illness —

including

the enhancement of rehabilitation and survivorship

Supportive care is the prevention and management of the adverse effects of cancer and its treatment across the entire continuum of a patient’s illness —

including

the enhancement of rehabilitation and survivorship


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What’s Up at HEGP in Supportive Care?

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RCP:Réunion de concertation pluridisciplinaire, (Staff) in Supportive care

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Second degree formation in supportive care (1st

in France)

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Many clinical trials

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Relationship with association in SCC

–

National (AFSOS)

–

International (MASCC)

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Outpatient care development

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Inpatient care development

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Supportive Care Unit in HEGP

Specific dedicated medical hospitalisation structure

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6 beds (1 pain, 1 interventional, 4 standards)

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Coordination (pain, psycho-oncology, palliative care, supportive care team)

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Anticipated situations to avoid emergencies hospitalisation

F.Scotté HEGP Cancérologie 21


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Hospital Medical Call Center

Patient1- Physician sends patient enrollment form to call center

nurse2- Call center

nurse calls patient to

collect toxicity data

4- Call center nurse sends patient data

to the pharmacy

3- Call center receives lab work results5- After physician’s validation,

pharmacist prepares the chemotherapy

6- Oncology team is ready for patient arrival. Chemotherapy is waiting for patient

Innovative way to follow our patient at Home: PROCHE program at HEGP


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As a result of PROCHE program, patient length of stay was reduced by 21%, from 247 min in Sept 09 to 186 min in Mar 10 (-51 min per patient stay).

Before PROCHE With PROCHE

186 min247 min

131 min

116 min

79 min

107 min

131 min

Results: Patient Length of StayThis slide deck is being provided in response to an unsolicited request and is intended

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COM.CAB.11.03.03 03/2011

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A shared purpose…

‘To provide a world class, patient-focused cancer service for the prostate cancer patients and the wider health community and in doing so support the development and discovery of treatment and supportive cancer care’

Is this what we want?


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COM.CAB.11.03.03 03/2011

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Insights into the Dynamics of Survival in Advanced Prostate Cancer: Highlights of TROPIC Study

Dr. Stéphane Oudard


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Identifying the Unmet Medical Need in Second- Line Treatment

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Despite a survival benefit with first-line chemotherapy with docetaxel, mHRPC patients inevitably progress, most within 9 months1-5

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<50% of patients with mHRPC receive second-line therapy6

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However, many mHRPC patients have a good performance status

and desire additional treatment7

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Only options were palliative chemotherapy, supportive care, or investigational agents8

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Following progression on docetaxel6,9:•

There was no approved agent after disease progression

•

No agent demonstrated an improvement in overall survival (OS)

1. Petrylak DP, et al. N Engl J Med. 2004;351(15):1513-1520. 2. Tannock IF, et al. N Engl J Med. 2004;351(15):1502-1512. 3. Oudard S, et al. J Clin Oncol. 2005;23(15):3343-3351. 4. Nelius T, et al. BJU Int. 2006;98(3):580-585. 5. Nelius T, et al. Onkologie. 2005;28(11):573-578. 6. Garmey EG, et al. Clin Adv Hematol Oncol. 2008;6(2):118-132. 7. Fitzpatrick JM, et al. Eur Urol Suppl. 2009;8(9):738-746. 8. Rosenberg JE, et al. Cancer. 2007;110(3):556-563. 9. Sternberg CN, et al. J Clin Oncol. 2009;27(32):5431-5438.


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COM.CAB.11.03.03 03/2011

XY

X Y

Docetaxel

Cabazitaxel

-OH

-OCH3 -OCH3

-OCCH3

O

99th AACR annual meeting, San Diego, April 2008 (abstract #3227)

Cabazitaxel: A Next Generation Taxane

Both extracted from needles of the

European Yew tree

Taxus baccata

These two radicals confer very specific properties to cabazitaxel


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http://upload.wikimedia.org/wikipedia/commons/6/69/TXbaccata.jpg

COM.CAB.11.03.03 03/2011

Cabazitaxel: Tubulin-Targeting Drug

Microtubule Stabilizer1,2

Promotes tubulin assembly

Stabilizes microtubules against depolymerization

Inhibits mitotic progression

1. Engels FK et al. Br J Cancer 2005;93:173-177; 2. Greenberger LM, Sampath D. Resistance to taxanes. In: Teicher BA, ed. Cancer Drug Discovery and Development: Cancer Drug Resistance. Totowa, New Jersey: Humana Press; 2006:329-358; 3. Mita AC et al, Clin Cancer Res. 2009, 15, 723-730

Cabazitaxel

Courtesy of sanofi-aventis Web site: http://www.oncology.sanofi-

aventis.com/tcl/cp/en/layout.jsp?scat=4BF14C98-DE0C-4464-A2F1-

6AA9C9D806A4. Accessed March 22, 2010.

Cabazitaxel was selected out of 450

molecules for its specific properties:

Greater penetration of the blood

brain barrier compared with

docetaxel and paclitaxel in an in vivo preclinical model3

Active in vitro and in vivo on

tumors resistant to Taxotere3


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http://www.oncology.sanofi-aventis.com/tcl/cp/en/layout.jsp?scat=4BF14C98-DE0C-4464-A2F1-6AA9C9D806A4



COM.CAB.11.03.03 03/2011

Overview of TROPIC Study

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Phase III TROPIC Study: 146 Sites in 26 Countries1

1. de Bono JS, Oudard S, Ozguroglu M, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154.


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COM.CAB.11.03.03 03/2011

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Adapted from: de Bono JS, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154.

Overall Survival This slide deck is being provided in response to an unsolicited request and is intended

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COM.CAB.11.03.03 03/2011

No Worsening of Performance Status (PS)

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DOF.TROPIC.CSR/p91/Fig10de Bono JS, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154.


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Adverse Events

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The most common toxic effects of cabazitaxel were hematological1

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The most frequent hematological grade 3 or higher adverse events were neutropenia, leukopenia, and anemia 1

•

The most common nonhematological grade 3 or higher adverse event

was diarrhea, which was managed expectantly1

•

Grade 3 peripheral neuropathy was uncommon (reported in three [1%] patients in each group)

1

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Overall, peripheral neuropathy (all grades) was reported during the study in 52 (14%) patients in the cabazitaxel group and 12 (3%) in the mitoxantrone group1

•

Peripheral edema (all grades) occurred in 34 (9%) patients in each group.

1

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18 (5%) patients treated with cabazitaxel and nine (2%) treated with mitoxantrone died within 30 days of the last infusion.1

•

The most frequent cause of death in the cabazitaxel group was neutropenia and its clinical consequences.

1

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1. de Bono JS, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154.


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Overall Survival

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Patients in the cabazitaxel arm had significantly improved overall survival compared with those in the mitoxantrone arm1

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15.1 months median overall survival vs 12.7 months with mitoxantrone (HR=0.70, p < 0.0001)

1

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In the United States, Israel, Curaçao and Brazil, where cabazitaxel is approved, it was the first drug to demonstrate overall survival in prostate patients previously treated with docetaxel.

Cabazitaxel has been filed in Europe and is pending review.

•

The overall survival benefit with cabazitaxel was consistent across all subgroups, including patients who progressed during docetaxel treatment and those who had received high doses of docetaxel1

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1. de Bono JS, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154.


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Assessing Patient Eligibility for Cabazitaxel

Dr. Stéphane Oudard


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Criteria To Be Considered in Cabazitaxel Eligibility

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Metastatic HRPC progressing during or after docetaxel

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Health status of the patient–

More than chronological age

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Predictors of rapid progression


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TROPIC: Similar Survival Benefit in Young and Older Patients

Factor Subgroup Patient Number

Hazard Ratio (95% CI)

Favors CBZP

Favors MP

Age <65 295 0.81 (0.62-1.05) X -Age ≥65 460 0.66 (0.53-0.81) X -

*The protocol was amended after the first 59 patients were enrolled in order to

mandate that eligible patients had to have received >225 mg/m²

of docetaxel.

De Bono et al. Lancet, 2010, 376:1147-54


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SIOG Recommendations for Senior Men

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Treatment recommendations for older men with prostate cancer should be based on health status (mainly driven by comorbidities)

•

And patient preferences•

Not on chronological age

Droz JP et al, Crit Rev Oncol Hematol. 2010, 73: 61-91 Droz JP et al. BJU Int. 2010, 106: 462-69


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Consider Switching to Second-Line Chemotherapy at First Signs of Progression

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Key Indicators of Progression on Docetaxel

1. Eisenhauer EA, et al. Eur J Cancer. 2009;45(2):228-247. 2. de Bono JS, Oudard S, Ozguroglu M, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154. 3. Fitzpatrick JM, et al. Eur Urol Suppl. 2009;8(9):738-746.


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Final thoughts from the panel

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Questions?

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When given the microphone, please share your name, media outlet, and identify which panel member you are addressing


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COM.CAB.11.03.03 03/2011COM.CAB.11.03.03 03/2011

NEW PERSPECTIVES: A Multidisciplinary Approach To Managing Advanced Prostate Cancer


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