Pembrolizumab in Asia-Pacific patients with advanced head and neck squamous cell carcinoma: analyses from KEYNOTE-012

Abstract

KEYNOTE-012 was a phase Ib, multicohort study designed to investigate efficacy and safety of pembrolizumab in advanced solid tumors. Results from the subset of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) from the Asia-Pacific region are reported. Patients with recurrent/metastatic HNSCC, measurable disease (Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST v1.1]), and Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 were eligible for enrollment in the HNSCC expansion cohort. Patients received pembrolizumab 200 mg every 3 weeks. Response was assessed every 8 weeks. Co-primary endpoints were safety and overall response rate (ORR; RECIST v1.1, central review). Secondary endpoints included overall survival (OS) and response duration (DOR). Patients enrolled at any of the five centers throughout the Asia-Pacific region were included in these analyses. Twenty-six patients with HNSCC from the Asia-Pacific region received pembrolizumab. Median age was 62 years; 65% had ECOG PS 1; 62% received ≥2 prior therapies for recurrent/metastatic disease. Sixteen (62%) patients experienced a treatment-related adverse event (AE) of any grade, including 2 (8%) patients who experienced ≥1 events of grade 3 severity. No treatment-related deaths occurred. ORR was 19% (95% confidence interval [CI], 7–39). After a median follow-up of 12 months (range, 2–21), median DOR was not reached (range, 6–17+ months); four of five responses lasted ≥6 months. Median OS was 12 months (95% CI, 5–17). Pembrolizumab was well tolerated and had durable antitumor activity in patients with HNSCC from the Asia-Pacific region

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