FDA approves Keytruda for locally advanced cutaneous squamous cell carcinoma
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The FDA expanded the approval of pembrolizumab to include treatment of patients with locally advanced cutaneous squamous cell carcinoma not curable by surgery or radiation, according to the agent’s manufacturer.
Pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — already had been approved for treatment of patients with recurrent or metastatic disease not curable by surgery or radiation.
The FDA based the new indication on results of the multicenter, nonrandomized, phase 2 KEYNOTE-629 trial, which included 159 patients with recurrent/metastatic or locally advanced cutaneous squamous cell carcinoma.
Patients received 200 mg pembrolizumab via IV every 3 weeks for up to 24 months, or until disease progression or unacceptable toxicity.
Objective response rate and duration of response as assessed by blinded independent central review served as the major efficacy outcomes.
Fifty-four patients (median age, 76 years; range, 35-95; 72% men; 83% white) in the study population had locally advanced disease. All of these patients had ECOG performance status of 0 (41%) or 1 (59%). Twenty-two had received at least one prior therapy and 63% had received radiation.
Results of a second interim analysis showed an ORR of 50% (95% CI, 36-64) — including a 17% complete response rate and 33% partial response rate — among patients with locally advanced disease.
Median follow-up was 13.4 months. Median duration of response had not been reached (range, 1+ months to 17.2+ months). The majority (81%) of responses lasted at least 6 months, and 37% of responses lasted at least 12 months.
In the overall study population, adverse events appeared similar to those observed among patients who received single-agent pembrolizumab for treatment of melanoma or non-small cell lung cancer. Grade 3 or grade 4 laboratory abnormalities included lymphopenia (10%) and decreased sodium (10%).
“This approval is great news for these patients,” Vicki Goodman, MD, vice president for clinical research at Merck Research Laboratories, said in a company-issued press release. “Keytruda has shown meaningful efficacy [among] patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation. This expanded indication reinforces the role of Keytruda in this cancer type, which is the second most common form of nonmelanoma skin cancer.”
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