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FDA Approves Pembrolizumab for Patients With Cutaneous Squamous Cell Carcinoma
On June 24, 2020, the FDA approved pembrolizumab (Keytruda; Merck) for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) incurable via surgery or radiation.
This approval was based on efficacy data from the multi-center, nonrandomized, open-label KEYNOTE-629 clinical trial, and supports 2 different dosing options (ie, 200 mg every 3 weeks or 400 mg every 6 weeks).
Patients were included in the trial if they had not received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody and did not require immunosuppression.
Pembrolizumab 200 mg was administered every 3 weeks for up to 24 months or until disease progression or unacceptable toxicity occurred. Tumor status was assessed every 6 weeks during year 1 and every 9 weeks during year 2.
The major end points of the study were the objective response rate (ORR) and duration of response as assessed by blinded independent central review according to RECIST 1.1; these measures were modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Findings demonstrated an ORR and median response duration of 34% (95% CI, 24-44) and not reached (range, 2.7-13.1+ months), respectively
Of note, adverse events in patients with cSCC in the KEYNOTE-629 trial were similar to those of patients given pembrolizumab monotherapy in other clinical trials, the most common being fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.—Hina M. Porcelli
Source: US Food and Drug Administration. FDA approves pembrolizumab for cutaneous squamous cell carcinoma. June 24, 2020. www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-cutaneous-squamous-cell-carcinoma. Accessed June 24, 2020.
