FDA Expands Pembrolizumab Label for Locally Advanced Cutaneous Squamous Cell Carcinoma
Posted: Wednesday, July 7, 2021
On July 6, the U.S. Food and Drug Administration (FDA) expanded the indication for the anti–PD-1 therapy pembrolizumab (Keytruda) as monotherapy for patients with locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation. Pembrolizumab had received FDA approval for use in cutaneous squamous cell carcinoma in June 2020 for monotherapy in patients with recurrent or metastatic disease that is not curable by surgery or radiation.
The FDA’s decision is based on the results of the second interim analysis for the phase II multicenter, multicohort, open-label KEYNOTE-629 clinical trial. Patients with recurrent or metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma were enrolled. Patients with autoimmune disease or who had a medical condition requiring immunosuppression were excluded.
Patients received 200 mg of intravenous pembrolizumab every 3 weeks until documented disease progression, unacceptable toxicity, or a maximum of 24 months. Patients with initial radiographic disease progression could receive additional doses of pembrolizumab with confirmation of disease progression unless disease progression was symptomatic, rapidly progressive, required urgent intervention, or occurred with a decline in performance status. Tumor status was evaluated every 6 weeks in the first year and every 9 weeks in the second year.
The median duration of exposure was 6.9 months in 159 patients administered pembrolizumab. Results showed an overall response rate of 50% in patients given pembrolizumab. Additionally, there was a 17% complete response rate and a 33% partial response rate. After a median follow-up of 13.4 months, the median duration of response was not reached. Of the 27 patients who responded to treatment, 81% achieved a duration of response of 6 months or longer, and 37% achieved a duration of response of 12 months or longer.