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
Ref: Businesswire | Image: Merck
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