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Exelixis Announces Results from Phase 2 Trial of Cabozantinib in Combination with Pembrolizumab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma at ASCO 2022
– Results demonstrated an objective response rate of 54% and an overall clinical benefit rate of 91% – ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc.
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– Results demonstrated an objective response rate of 54% and an overall clinical benefit rate of 91% –\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL) today announced results from a phase 2, investigator-sponsored trial of cabozantinib (CABOMETYX®) in combination with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The data will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting during Oral Abstract Session: Head and Neck Cancer on Friday, June 3 beginning at 2:45 p.m. CT.\n\nThe trial met its primary endpoint of objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at 54%. The overall clinical benefit rate was 91%. At a median follow-up of 10.6 months, the one-year progression-free survival rate was 54.0% (95% confidence interval [CI]: 31.5-72.0%), and median progression-free survival was 14.6 months. The one-year overall survival (OS) rate was 68.4% (95% CI: 45.1-83.5%; median OS: 22.3 months). For the 17 patients with a PD-L1 combined positive score (CPS) under 20, the one-year OS rate was 54.9% (95% CI: 24.5-77.5%; median OS: 14.6 months). For the 17 patients with a CPS score of 20 or more, the one-year OS rate was 83.6% (95% CI: 48.0-95.7%; median OS: 32.9 months).\n\n“Metastatic head and neck cancer is a challenging disease to treat, particularly following disease progression after definitive therapy, meaning patients need additional options beyond radiation and chemotherapy,” said Nabil F. Saba, M.D., Professor and Vice Chair, Hematology and Medical Oncology, The Lynne and Howard Halpern Chair in Head and Neck Cancer Research, Co-Director of Head and Neck Cancer Multidisciplinary Program, Winship Cancer Institute, Emory University, and primary investigator of the investigator-sponsored trial. “These results showing promising clinical activity of cabozantinib in combination with pembrolizumab are encouraging to these patients who face poor outcomes.”\n\nIn this phase 2 trial, eligible patients had recurrent or metastatic HNSCC that was deemed inoperable, with measurable disease per RECIST version 1.1, a life expectancy of at least 3 months and an Eastern Cooperative Group Performance Status of 0 or 1. Of the 36 evaluable patients, 61% had cancer in the oropharynx, 16% in th...