The China National Drug Administration approved Merck’s Keytruda for the treatment of adult patients with unresectable or metastatic melanoma following failure of one prior line of therapy. This is the first approval of an anti-PD-1 therapy for advanced melanoma in China.
The approval of Keytruda in China was based on overall response rate data from the phase Ib KEYNOTE-151 study, which evaluated Keytruda monotherapy in Chinese patients with previously treated locally advanced or metastatic melanoma who received one prior line of systemic therapy.
In 2018, the CNDA granted priority review status to Keytruda, which accelerated the approval process by allowing for simultaneous clinical validation for the first time – creating an industry leading approval turnaround time for imported cancer medicine in China.
KEYNOTE-151 is an open-label, single-arm, multi-center, phase Ib trial evaluating Keytruda monotherapy in 103 Chinese patients with previously treated locally advanced or metastatic melanoma who received one prior line of systemic therapy.
Patients were enrolled to receive KEYTRUDA at a dose of 2 mg/kg every three weeks. The primary efficacy outcome measure was ORR as assessed by Blinded Independent Central Review using RECIST 1.1. Secondary efficacy outcome measures were duration of response and progression-free survival (as assessed by BICR per RECIST 1.1 and irRECIST), ORR (as assessed by BICR per irRECIST) and overall survival.
