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  • 1. This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck. NEW PERSPECTIVES: A Multidisciplinary Approach To Managing Advanced Prostate Cancer PRESS BRIEFING Sunday, March 20, 2011 09:00 – 11:00AMCOM.CAB.11.03.03 03/2011
  • 2. This slide deck is being provided in response to an Disclosures unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• 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®. 2 COM.CAB.11.03.03 03/2011
  • 3. This slide deck is being provided in response to an Press Briefing Agenda unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• 9:00 – 9:05 AM – Welcome/Introduction of Panel• 9:05 – 9:25 AM – The MDT Approach to Improving Survival in Prostate Cancer• 9:25 – 9:40 AM – Highlights of TROPIC Study• 9:40 – 9:55 AM – Assessing Patient Eligibility for Cabazitaxel• 9:55 – 10:00 AM – Final Points• 10:00 – 10:15 AM – Questions from the Media• 10:15 – 10:20 AM – Closing Remarks• 10:20 – 11:00 AM – Interviews with Panelists 3 COM.CAB.11.03.03 03/2011
  • 4. This slide deck is being provided in response to an Panelist Introductions unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• 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• Stéphane Oudard, M.D., Ph.D., Professor of Oncology and Chief of the Oncology Translational Research Unit at the Georges Pompidou Hospital, Paris, France 4 COM.CAB.11.03.03 03/2011
  • 5. This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.The MDT Approach to Improving Survival inProstate CancerDr. Amit BahlDr. Stéphane Oudard 5 COM.CAB.11.03.03 03/2011
  • 6. This slide deck is being provided in response to an Prostate Cancer Overview unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• Prostate cancer is the second-most common cancer in men (worldwide) and the third leading cause of cancer death (in developed countries)1,2• Established risk factors include3: • Age: the median age at diagnosis is 68 years • Race: African American men have the highest incidence rates • Family history• 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. 6 COM.CAB.11.03.03 03/2011
  • 7. This slide deck is being provided in response to anTreatment Options for Prostate Cancer unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck. Rising Metastatic Metastatic No Localised PSA hormone hormonecancer disease after local sensitive resistant therapy Active surveillance Curative °Radical prostatectomy or external beam radiation therapy° therapy or brachytherapy Hormonal treatment Chemotherapy Clinical trials COM.CAB.11.03.03 03/2011
  • 8. This slide deck is being provided in response to an Treatment of Advanced Prostate Cancer unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• 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)• 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 Heidenreich A, et al. (2010 update) www.uroweb.org 2Mohler J, et al. (2009 update) www.nccn.org 1 Basch EM, et al. J Clin Oncol 2007;25:5313–18 4Horwich A, et al. Ann Oncol 2009;20(Suppl 4):76–8 3 COM.CAB.11.03.03 03/2011
  • 9. This slide deck is being provided in response to an Prostate Cancer: Management unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• Earlier diagnosis means more “curable” disease• 80% of ‘high risk’ prostate cancer will develop biochemical relapse or clinical failure within 10 years1• High risk and advanced or metastatic disease require: – Multiple systemic therapies – Ideally within the multi-disciplinary team approach D’Amico. JCO 2003, 21, 2163 1 . COM.CAB.11.03.03 03/2011
  • 10. Multidisciplinary Teams in Prostate Cancer: This slide deck is being provided in response to an unsolicited request and is intended only forPatient-Centric Management members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck. 10 COM.CAB.11.03.03 03/2011
  • 11. This slide deck is being provided in response to anThe Extended Team Supports the Patient unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.Treating physicians Diagnostic Supporting physicians Urologist management Pain management Medical oncologist Radiologist NeurosurgeonRadiation oncologist Pathologist Psychiatrist Onco-geriatrician Primary care physician Clinical and Patient fundamentalresearch teams Support staff Specialist nurse Dietician Physiotherapist Palliative care specialist COM.CAB.11.03.03 03/2011
  • 12. Increased Collaboration Between This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print, Urologists and Oncologists distribute, or otherwise disseminate this slide deck.• As the role of chemotherapy for the treatment of HRPC evolves, the need for strong partnerships between urologists and oncologists increases1• Optimal patient management should involve close coordination between urologists and oncologists to ensure that all appropriate, and potentially beneficial, treatment options are explored1• Only about 30% of patients with mHRPC are referred for chemotherapy by their urologist2 1. Kibel AS. Urology 2005; 65 (Suppl): 13–18. 2. Crawford ED. Rev Urol 2003; 5 (Suppl 2): S48–52. 12 COM.CAB.11.03.03 03/2011
  • 13. Patient Benefits of MDT Approach in Prostate This slide deck is being provided in response to an unsolicited request and is intended only for Cancer Care members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• Mutual alignment of expectations and treatment goals among urologists, oncologists, and patients can improve patient care.1• “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 13 COM.CAB.11.03.03 03/2011
  • 14. Patient Benefits of MDT Approach in Prostate This slide deck is being provided in response to an unsolicited request and is intended only for Cancer Care members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• Core team members provide expert multidimensional approach to identifying disease progression and moving patients towards more effective therapies as soon as possible.1• 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. 14 COM.CAB.11.03.03 03/2011
  • 15. MDT Approach Influences Diagnostic and This slide deck is being provided in response to an unsolicited request and is intended only for Treatment Decisions members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• 296 patients presented MDT with an outside diagnosis of a urologic malignancy N/A 17.1% 38% change in  Other 10.4% diagnostic  decision or  Change in Dx and Tx 8.9% treatmentChange in Dx/no change in Tx 5.6% No change Dx/change Tx 23.4% No change in Dx or Tx 34.6% 0.0% 10.0% 20.0% 30.0% 40.0% Dx = diagnostic decision. Tx = treatment decision Kurpad R, et al. Urol Oncol 2009 [Epub ahead]of print] COM.CAB.11.03.03 03/2011
  • 16. Multidisciplinary Teams in Prostate Cancer: This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print, NICE Guidance: improving outcomes distribute, or otherwise disseminate this slide deck.• All patients with urological cancer – both newly diagnosed and existing – should be managed by appropriate MDTs1• The MDT can comprise of: lead clinician; urologist; specialist nurse; radiologist; pathologist; oncologist; and palliative care specialist1 1. NICE. The Manual. 2002 16 COM.CAB.11.03.03 03/2011
  • 17. This slide deck is being provided in response to an7 OUT OF 10 unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck. 17 COM.CAB.11.03.03 03/2011
  • 18. This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.Practical example:European Hospital Georges Pompidou‘Prendre Soin’(Taking Care)Stephane Oudard COM.CAB.11.03.03 03/2011
  • 19. This slide deck is being provided in response to anSupportive Care in Cancer unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.Supportive care is the prevention and management ofSupportive care is the prevention and management of the adverse effects of cancer and its treatment across the adverse effects of cancer and its treatment across the entire continuum of a patient’s illness — including the entire continuum of a patient’s illness — including the enhancement of rehabilitation and survivorship the enhancement of rehabilitation and survivorship 19 COM.CAB.11.03.03 03/2011
  • 20. What’s Up at HEGP in Supportive This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print, Care? distribute, or otherwise disseminate this slide deck.• RCP:Réunion de concertation pluridisciplinaire, (Staff) in Supportive care• Second degree formation in supportive care (1st in France)• Many clinical trials• Relationship with association in SCC – National (AFSOS) – International (MASCC)• Outpatient care development• Inpatient care development 20 COM.CAB.11.03.03 03/2011
  • 21. This slide deck is being provided in response to an Supportive Care Unit in HEGP unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.Specific dedicated medical hospitalisation structure• 6 beds (1 pain, 1 interventional, 4 standards)• Coordination (pain, psycho-oncology, palliative care, supportive care team)• Anticipated situations to avoid emergencies hospitalisation F.Scotté HEGP Cancérologie 21 COM.CAB.11.03.03 03/2011
  • 22. Innovative way to follow our patient This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print, at Home: PROCHE program at HEGP distribute, or otherwise disseminate this slide deck. Hospital 1- Physician sends Medical Call Center patient enrollment form to call center nurse 2- Call center nurse calls Patient patient to collect toxicity data 4- Call center nurse sends 3- Call center receives5- After physician’s validation, lab work results pharmacist prepares the patient data chemotherapy to the pharmacy 6- Oncology team is ready for patient arrival. Chemotherapy is waiting for patient COM.CAB.11.03.03 03/2011
  • 23. This slide deck is being provided in response to an Results: Patient Length of Stay unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.As a result of PROCHE program, patient length of stay wasreduced by 21%, from 247 min in Sept 09 to 186 min in Mar 10(-51 min per patient stay). 247 min 186 min 131 min 131 min 79 min 116 min 107 min Before PROCHE With PROCHE COM.CAB.11.03.03 03/2011
  • 24. This slide deck is being provided in response to an unsolicited request and is intended only forA shared purpose… members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck. ‘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? 24 COM.CAB.11.03.03 03/2011
  • 25. This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.Insights into the Dynamics of Survival inAdvanced Prostate Cancer: Highlights ofTROPIC StudyDr. Stéphane Oudard 25 COM.CAB.11.03.03 03/2011
  • 26. Identifying the Unmet Medical Need in Second- This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print, Line Treatment distribute, or otherwise disseminate this slide deck.• Despite a survival benefit with first-line chemotherapy with docetaxel, mHRPC patients inevitably progress, most within 9 months1-5 • <50% of patients with mHRPC receive second-line therapy6 • However, many mHRPC patients have a good performance status and desire additional treatment7 • Only options were palliative chemotherapy, supportive care, or investigational agents8• 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. 26 COM.CAB.11.03.03 03/2011
  • 27. This slide deck is being provided in response to an Cabazitaxel: A Next Generation Taxane unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck. X Y Y O X Docetaxel -OH -OCCH3 Cabazitaxel -OCH3 -OCH3 Both extracted from needles of the European Yew tree Taxus baccataThese two radicals confer veryspecific properties to cabazitaxel 99th AACR annual meeting, San Diego, April 2008 (abstract #3227) COM.CAB.11.03.03 03/2011
  • 28. This slide deck is being provided in response to an Cabazitaxel: Tubulin-Targeting Drug unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck. CabazitaxelMicrotubule Stabilizer1,2 Promotes tubulin assembly Stabilizes microtubules against depolymerization Inhibits mitotic progressionCabazitaxel was selected out of 450molecules 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 Courtesy of sanofi-aventis Web site: http://www.oncology.sanofi- tumors resistant to Taxotere3 aventis.com/tcl/cp/en/layout.jsp?scat=4BF14C98-DE0C-4464-A2F1- 6AA9C9D806A4. Accessed March 22, 2010. 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 COM.CAB.11.03.03 03/2011
  • 29. This slide deck is being provided in response to an Overview of TROPIC Study unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.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. 29 COM.CAB.11.03.03 03/2011
  • 30. This slide deck is being provided in response to anOverall Survival unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck. Adapted from: de Bono JS, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154. 30 COM.CAB.11.03.03 03/2011
  • 31. This slide deck is being provided in response to anNo Worsening of Performance Status (PS) unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck. DOF.TROPIC.CSR/p91/Fig10 de Bono JS, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154. 31 COM.CAB.11.03.03 03/2011
  • 32. This slide deck is being provided in response to an Adverse Events unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• The most common toxic effects of cabazitaxel were hematological1• 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 • 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• 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 1. de Bono JS, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154. 32 COM.CAB.11.03.03 03/2011
  • 33. This slide deck is being provided in response to an Overall Survival unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• Patients in the cabazitaxel arm had significantly improved overall survival compared with those in the mitoxantrone arm1 • 15.1 months median overall survival vs 12.7 months with mitoxantrone (HR=0.70, p < 0.0001) 1• 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 1. de Bono JS, et al; for the TROPIC Investigators. Lancet. 2010;376(9747):1147-1154. 33 COM.CAB.11.03.03 03/2011
  • 34. This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.Assessing Patient Eligibilityfor CabazitaxelDr. Stéphane Oudard 34 COM.CAB.11.03.03 03/2011
  • 35. Criteria To Be Considered in This slide deck is being provided in response to an unsolicited request and is intended only forCabazitaxel Eligibility members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• Metastatic HRPC progressing during or after docetaxel• Health status of the patient – More than chronological age• Predictors of rapid progression COM.CAB.11.03.03 03/2011
  • 36. TROPIC: Similar Survival Benefit in Young and This slide deck is being provided in response to an unsolicited request and is intended only for Older Patients members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.Factor Subgroup Patient Hazard Ratio Favors Favors Number (95% CI) CBZP MPAge <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 tomandate that eligible patients had to have received >225 mg/m² of docetaxel. De Bono et al. Lancet, 2010, 376:1147-54 COM.CAB.11.03.03 03/2011
  • 37. This slide deck is being provided in response to an SIOG Recommendations for Senior Men unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.• 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 COM.CAB.11.03.03 03/2011
  • 38. Consider Switching to Second-Line This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print,Chemotherapy at First Signs of Progression distribute, or otherwise disseminate this slide deck. 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. 38 COM.CAB.11.03.03 03/2011
  • 39. This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.Final thoughts from the panel 39 COM.CAB.11.03.03 03/2011
  • 40. This slide deck is being provided in response to anQuestions? unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck. When given the microphone, please share your name, media outlet, and identify which panel member you are addressing 40 COM.CAB.11.03.03 03/2011
  • 41. This slide deck is being provided in response to an unsolicited request and is intended only for members of the media. Do not copy, print, distribute, or otherwise disseminate this slide deck.NEW PERSPECTIVES:A Multidisciplinary ApproachTo Managing Advanced ProstateCancer COM.CAB.11.03.03 03/2011

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