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H2H studies of anti-EGFR vs anti-VEGF in 1

st

-line mCRC

1. Heinemann et al. Lancet Oncol 2014 2. Schwatzberg et al. J Clin Oncol 2014. 3. Lenz et al. Ann Oncol 2014; 25 (supppl 5): 438-13.

PEAK

2

FIRE-3

1

CALGB 80405

3

Sponsors/

Collaborators

Amgen

University of Munich –

Klinikum Grosshadern Merck

Cancer and Leukaemia Group B

National Cancer Institute (NCI)

Trial

design

Phase II, randomized,

Phase III, randomized

Phase III, randomized

Number of

patients

285

592

2283

population

Untreated KRASwt mCRC

Untreated KRASwt mCRC

Untreated KRASwt mCRC

Primary

endpoint

Progression free survival

(PFS)

Overall response rate

(ORR)

Overall survival

(OS)

Secondary

endpoints

OS, ORR, safety

PFS, OS, resection rate, and

safety

PFS, ORR, resection rate, and

safety

Chemotherapy

partner

FOLFOX

FOLFIRI

FOLFOX or FOLFIRI