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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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Efficacy

Paul Meyers, MD

Vice-Chairman, Dept of PediatricsMemorial 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

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


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


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


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


COG

Patient Records

CRFs

Database

1

2

Patient Records

Clinical Sites

3

2003

3

Patient Records

IDM

Data Sources

2403.03


Baseline Demographics and Disease Characteristics

2120.03


Primary Analysis: DFS

2003 ITT

2134.01


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


Primary Analysis: Survival

2003 ITT

2135.01


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


COG

Patient Records

CRF

Database

1

2

Patient Records

Clinical Sites

3

Patient Records

IDM

Data Sources

2006

2455.01


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


Confirmatory Analysis 2006: Survival

2006 ITT

2545.01


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


Safety

2457.01


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

2428.01


Patient Discontinuation (Maintenance)

2122.02


1993-2002

1987-1992

1981-1986

1975-1980

Osteosarcoma: Overall Survival(SEER Ages 0 - 29)

2094.04


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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