FDA批准第一个抗PD1单抗？FDA的加速批准可不是主要是基于 KEYNOTE-001 phase1b 他的二期是做完了的，三期我忘了 The approval of KEYTRUDA was based on data from a multi-center, open-label, randomized, dose-comparative study cohort of the ongoing KEYNOTE-001 Phase 1b trial in patients with unresectable or metastatic melanoma and progression of disease. Key eligibility criteria included prior treatment with ipilimumab (two or more doses at 3 mg/kg or higher) and a BRAF or MEK inhibitor, if BRAF V600 mutation positive; and disease progression within 24 weeks following the last dose of ipilimumab. Patients were randomized to receive 2 mg/kg (n=89) or 10 mg/kg (n=84) of KEYTRUDA every 3 weeks until unacceptable toxicity or disease progression. The major efficacy outcome measures were confirmed overall response rate as assessed by blinded independent central review using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and duration of response. Tumor response was assessed every 12 weeks.查看更多
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