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ASCO/FDA Workshop on Lung Cancer Endpoints Alexandria, VA April 15, 2003

ASCO/FDA Workshop on Lung Cancer Endpoints Alexandria, VA April 15, 2003. Renzo Canetta, M.D. Vice President Life Cycle Management and Clinical Design & Evaluation Oncology Bristol-Myers Squibb Pharmaceutical Research Institute Wallingford, CT, USA. US Europe Japan .

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ASCO/FDA Workshop on Lung Cancer Endpoints Alexandria, VA April 15, 2003

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  1. ASCO/FDA Workshopon Lung Cancer EndpointsAlexandria, VAApril 15, 2003 Renzo Canetta, M.D. Vice President Life Cycle Management and Clinical Design & Evaluation Oncology Bristol-Myers Squibb Pharmaceutical Research InstituteWallingford, CT, USA

  2. US Europe Japan Overall survival in randomized trials is the accepted standard for all recent approvals An intermediate position: randomized trials usually required, but other endpoints (i.e. RR, TTP and QoL) and/or methodologies (i.e. meta-analyses) utilized Objective response rate in non-randomized trials (with independent committee assessment) for all recent approvals Worldwide Endpointsfor Approval in Lung Cancer

  3. Drugs Specifically Approved for NSCLC

  4. Drugs Specifically Approved for SCLC

  5. Drugs Generically Approved for Lung Cancer (or Bronchogenic Carcinoma)

  6. Registrational Trials for Taxol in NSCLC: Classical EndpointsCombinations with Cisplatin Study # Design RR (%) TTP (mos.) OS (mos). -165 HD-Taxol/cisplatin 30 4.9 10.0 ECOG vs. p<0.001p=0.0042 p=0.0785* (n=599) Etoposide/cisplatin 14 2.7 7.4 LD-Taxol/cisplatin 26 4.3 9.3 vs. p=0.003p=0.0504 p=0.1253* Etoposide/cisplatin 14 2.7 7.4 -103 Taxol/cisplatin 36 5.0 9.9 EORTC vs. p=0.031 p=0.7229 p=0.8024 (n=332) Teniposide/cisplatin 25 5.1 9.5 -208 Taxol/cisplatin 24 4.3 8.1 Gatzemeier vs. p=0.047 p=0.085** p=0.862 (n=414) Cisplatin 16 3.2 8.6 *When Taxol arms were pooled: 9.7 vs. 7.4 mos., p=0.0492 **When secondary therapy considered progression: 4.1 vs. 2.7 mos., p=0.0259

  7. Registrational Trials for Taxol in NSCLC: Quality of LifeCombinations with Cisplatin Study # Design Superior Outcome* -165 HD Taxol/cisplatin ECOG vs. (n=599) Etoposide/cisplatin LD Taxol/cisplatin Lung cancer symptoms (p=0.027) vs. Etoposide/cisplatin -103 Taxol/cisplatin Functioning: physical (p=0.002), role (p=0.021), social (p=0.030); EORTC vs. global health status (p=0.022); fatigue (p=0.017) (n=332) Teniposide/cisplatin Peripheral neuropathy (p=0.008) -208 Taxol/cisplatin Functioning: physical (p=0.054); nausea & vomiting (p=0.0003); Gatzemeier vs. appetite loss (p=0.020); constipation (p=0.032) (n=414) Cisplatin Peripheral neuropathy (p=0.0001); hair loss (p=0.0001) *For ECOG: FACT-L; for EORTC and Gatzemeier: EORTC QLQ-30, LC-13

  8. Registrational Trials for Taxol in NSCLC: Classical EndpointsSingle Agent Study # Design RR (%) TTP (mos.) OS (mos). % 1-yr. -224** Taxol 15 3.9 6.8 31 Thatcher vs. p=0.0001* p=0.0373 (n=157) BSC -- 0.5 4.8 28 -029 Taxol 17 2.1 4.4 40 ECOG vs. (n=118) Merbarone 2 1.2 4.4 18 vs. Piroxantrone 2 1.5 5.9 21 p=0.034 p=0.021 p=n.s. -123 Taxol 20 -- -- -- Yoneda (n=15) -186 A Taxol 32 -- 7.5 22 Furuse (n=60) -186 B Taxol 38 -- 11.2 48 Sekine (n=61) *When censoring for secondary therapy: 4.0 vs. 1.2 months, p=0.0001 **Quality of Life (Rotterdam Symptom Checklist) favored Taxol for functional activity (p=0.043) and BSC for physical score (p=0.060)

  9. Japan:Examples of Registrational Trials (1990-2000) in NSCLC* Agent Author Pts. RR% OS (wks.) Docetaxel Kunitoh 75 18.6 42 Kudoh 72 25.0 - Gemcitabine Takada 73 26.0 44 Yokoyama 67 20.9 39 Paclitaxel Furuse 60 31.6 30 Sekine 61 38.0 49 Vinorelbine Furuse 79 29.1 40 Irinotecan Fukuoka 72 31.9 41 *From Fukuoka, IASLC 2001

  10. Japan: Examples of Phase IV Commitments in NSCLC Study # Design RR (%) TTP (mos.) % 1-yr. A Vindesine/cisplatin 21.8 49.6 47.6 (n=203) vs. p=0.586 Irinotecan/cisplatin 28.6 44.7 42.6 B Vindesine/cisplatin 31.7 45.6 38.3 (n=380) vs. Irinotecan/cisplatin 43.7 50.0 46.5 vs. Irinotecan 20.5 46.0 41.8 p=0.115* C Irinotecan/cisplatin (n=602) vs. Gemcitabine/cisplatin vs. Vinorelbine/cisplatin vs. Paclitaxel/carboplatin *For stage IV subset: 36.4 vs. 50.0 vs. 42.1 weeks, p=0.004 RESULTS TO BE PRESENTED AT ASCO (JUNE 2003) AND IASLC (AUGUST 2003)

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