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Efficacy

Efficacy. Paul Meyers, MD Vice-Chairman, Dept of Pediatrics Memorial Sloan-Kettering Cancer Center. 2023.01. Osteosarcoma Survival: SEER Data. 1993-2002. 2503.01. 1.0. 0.8. 12. 12. MTP Cohort 1 (12wk). 21. 20. Historical control. 16. 11. MTP Cohort 2 (24wk). 0.6.

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Efficacy

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  1. Efficacy Paul Meyers, MD Vice-Chairman, Dept of PediatricsMemorial Sloan-Kettering Cancer Center 2023.01

  2. Osteosarcoma Survival:SEER Data 1993-2002 2503.01

  3. 1.0 0.8 12 12 MTP Cohort 1 (12wk) 21 20 Historical control 16 11 MTP Cohort 2 (24wk) 0.6 Disease-Free Survival 0.4 0.2 0 0 2 4 6 8 10 12 Phase 2 Results in Relapsed Osteosarcoma with Lung Metastases Total Fail Years Kleinerman ES et al, Am.J. Clin. Onc. 18:93, 1995 2025.04

  4. Landmark Phase 3 Trial • NCI-sponsored, Cooperative Group study • Designed and conducted independently of corporate sponsor • Largest study completed in osteosarcoma • 178 sites – 1/3 of eligible incident cases in US • Newly diagnosed (within 30 days; age <31) • 678 non-metastatic resectable disease • 115 with more advanced disease 2027.01

  5. A+ Cisplatin, Doxorubicin, HDMTX, MTP Cisplatin, Ifosfamide,Doxorubicin, HDMTX, MTP B+ Phase 3 Study Design INDUCTION DEFINITIVESURGERY MAINTENANCE A Cisplatin Doxorubicin HDMTX A- Cisplatin, Doxorubicin, HDMTX Cisplatin, Ifosfamide, Doxorubicin, HDMTX B Ifosfamide Doxorubicin HDMTX B- 20 27 36 Weeks 2028.03

  6. Phase 3 Study Endpoints • DFS • Putative surrogate for OS • Prospectively defined primary endpoint • “To determine whether MTP can improve DFS…” • “To compare the results of a prospective, randomized trial of two chemotherapeutic regimens…” (A vs. B) • Survival • “To improve the survival of patients with osteogenic sarcoma” 2034.02

  7. COG Patient Records CRFs Database 1 2 Patient Records Clinical Sites 3 2003 3 Patient Records IDM Data Sources 2403.03

  8. Baseline Demographics and Disease Characteristics 2120.03

  9. Primary Analysis: DFS 2003 ITT 2134.01

  10. Disease-Free Survival 2003 ITT 100% 80% MTP 60% No MTP 40% N Events 20% MTP 338 102 no MTP 340 126 0% 0 2 4 6 8 10 12 Years Primary Analysis: DFS (Kaplan-Meier) 2041.03

  11. Primary Analysis: Survival 2003 ITT 2135.01

  12. Overall Survival 2003 ITT 100% MTP 80% 60% No MTP 40% N Events 20% MTP 338 63 no MTP 340 85 0% 0 2 4 6 8 10 12 Years Primary Analysis: Survival (Kaplan-Meier) 2038.04

  13. COG Patient Records CRF Database 1 2 Patient Records Clinical Sites 3 Patient Records IDM Data Sources 2006 2455.01

  14. Follow Up 2003 and 2006 2003 ITT 2006 ITT no MTP MTP MTP no MTP Time to Last Contact Time to Last Contact 2229.05

  15. Confirmatory Analysis 2006: Survival 2006 ITT 2545.01

  16. 0 2 4 6 8 10 12 Years Confirmatory 2006 Analysis: Survival (Kaplan-Meier) Overall Survival 2006 Data 100% MTP 80% No MTP 60% 40% N Events 20% MTP 338 73 no MTP 340 100 0% 2223.03

  17. Safety 2457.01

  18. Grade 3 or 4 Adverse Events Reported by ≥3% of Patients: Phase 3 ITT 2428.01

  19. Patient Discontinuation (Maintenance) 2122.02

  20. 1993-2002 1987-1992 1981-1986 1975-1980 Osteosarcoma: Overall Survival(SEER Ages 0 - 29) 2094.04

  21. MTP No MTP SEER 1987-1992 SEER 1993-2002 SEER 1981-1986 SEER 1975-1980 Osteosarcoma: Overall SurvivalSEER and COG 2006 Data (All Patients) 2504.01

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