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Soo Park, MD
Soo Park, MD
Posted: Friday, June 28, 2024
Neoadjuvant use of the PD-1 inhibitor pembrolizumab appears to be effective in treating resectable, locally advanced cutaneous squamous cell carcinoma, the results of a single-arm phase II trial have revealed. The study’s participants—all naive to anti–PD-1 therapy—had a high pathologic complete response rate of 57%, noted Florent Amatore, MD, PhD, of UPMC Hillman Cancer Center, Pittsburgh, and colleagues. The team described their findings during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 9591).
The trial’s primary endpoint was pathologic complete response, defined as 0% residual viable tumor. Among the secondary endpoints were safety and recurrence-free survival.
A total of 30 patients (median age, 79 years; 77% male) received at least one cycle of pembrolizumab. All had stage T3 or higher disease (or T2 with two or more high-risk features) and/or had node-positive disease.
Each patient received two cycles of pembrolizumab (200 mg every 3 weeks) prior to definitive surgery and 15 cycles of the agent after surgery. (Before definitive surgery, one patient withdrew consent, two died of COVID-19 infection, and one died of a non–ST-elevation myocardial infarction possibly related to pembrolizumab, which reflects the inherent risks of perioperative therapy in this patient population, the authors stated. One patient had not yet completed surgery when the study data were compiled.)
A pathologic complete response was reported in 15 of the 26 (57%) response-evaluable patients. Two patients (8%) had a pathologic partial response, and eight (31%) had a pathologic nonresponse.
None of the 15 patients who had a pathologic complete response experienced a relapse event, and in 14, it was possible to de-escalate postoperative radiotherapy. Median recurrence-free survival was 13.0 vs 10.5 months in the patients who did and did not have a pathologic complete response, respectively. Regarding safety, besides the single myocardial infarction, two grade 3 treatment-related adverse events occurred.
Disclosure: Dr. Amatore reported no conflicts of interest. For full disclosures of the other study authors, visit coi.asco.org.
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