The Food and Drug Administration (FDA) has expanded the approval of Keytruda® (pembrolizumab) to include the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC), in addition to recurrent or metastatic cSCC, that is not curable by surgery or radiation.

The approval was based on data from the second interim analysis of the phase 2 KEYNOTE-629 trial ( Identifier: NCT03284424), which included 54 patients with locally advanced cSCC. Patients received Keytruda 200mg intravenously every 3 weeks until disease progression, unacceptable toxicity or a maximum of 24 months. The main efficacy outcome measures were objective response rate (ORR) and duration of response (DOR).

Results showed an ORR of 50% (95% CI, 36-64), with 17% of patients achieving complete response and 33% having partial response. The median DOR had not yet been reached after a median follow-up of 13.4 months (range, 1.0+ to 17.2+ months). Among the 27 responding patients, 81% had a DOR of 6 months or longer, and 37% had a DOR of 12 months or longer.

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“Keytruda has shown meaningful efficacy in patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation,” said Dr Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “This expanded indication reinforces the role of Keytruda in this cancer type, which is the second most common form of non-melanoma skin cancer.”


  1. FDA approves expanded indication for Merck’s Keytruda® (pembrolizumab) in locally advanced cutaneous squamous cell carcinoma (cSCC). [press release]. Kenilworth, NJ: Merck; July 6, 2021. 
  2. Keytruda [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; 2021.

This article originally appeared on MPR