Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Expanded Indication in Patients with Locally Advanced Cutaneous Squamous Cell Carcinoma

Shots:

• The approval is based on data from the second interim analysis of the P-II KEYNOTE-629 trial assessing Keytruda (200mg, IV, q3w) in 159 patients with recurrent, metastatic, or LA cSCC that is not curable by surgery or radiation
• Results: ORR (50%); CR (17%); PR (33%), 81% had DOR of 6mos. or longer, and 37% had a DoR of 12mos. or longer, @median follow-up of 13.4mos., m-DoR had not reached & median duration of exposure was 6.9 mos.
• Keytruda is an anti-PD-1 therapy, acts by increasing the ability of the body’s immune system to help detect and fight tumor cells. In Jun’20, the therapy marks the first indication in recurrent or metastatic cSCC

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