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Exelixis Announces Detailed Phase 1b Results from Cohort 6 of COSMIC-021 Trial in Patients with Metastatic Castration-Resistant Prostate Cancer Presented at ESMO 2021
– New results for cabozantinib in combination with atezolizumab demonstrate a median progression-free survival in high-risk patients of 6.8 months as
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– New results for cabozantinib in combination with atezolizumab demonstrate a median progression-free survival in high-risk patients of 6.8 months as assessed by Blinded Independent Radiology Committee –\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL) today announced detailed results from the expanded cohort 6 of the phase 1b COSMIC-021 trial of cabozantinib (CABOMETYX®) in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer (CRPC). Cohort 6 included patients with metastatic CRPC who had been previously treated with the novel hormone therapies (NHT) enzalutamide and/or abiraterone acetate used along with prednisone. The data are being presented during the Proffered Paper Session: GU Tumours, Prostate today at 1:30 p.m. CEST at the 2021 European Society of Medical Oncology (ESMO) Congress (LBA24).\n\nEligible patients in the trial had measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) per investigator assessment, had progressed on prior NHT, and could have received prior docetaxel for metastatic hormone-sensitive disease. The analysis included 132 patients with metastatic CRPC, 101 of whom were high-risk, which was defined as having measurable visceral metastases and/or extrapelvic lymphadenopathy. The median follow-up for all patients was 15.2 months, and the primary endpoint was objective response rate (ORR) by investigator per RECIST 1.1.\n\nAs previously announced, in the high-risk patient population, investigator-assessed ORR was 27%, including 2% complete responses (CRs). The Blinded Independent Radiology Committee (BIRC)-assessed ORR was 18%, all partial responses (PRs). The disease control rate (CR + PR + stable disease) was 88% by investigator assessment and 84% by BIRC assessment.\n\nNew detailed results being presented at the 2021 ESMO Congress demonstrate that median progression-free survival per RECIST 1.1 for the high-risk population was 5.6 months (95% confidence interval [CI]: 5.4-8.2) as assessed by investigators and 6.8 months (95% CI: 5.5-9.7) as assessed by BIRC. The exploratory endpoint of overall survival for the high-risk patient population was 18.4 months (95% CI: 13.6-24.7). Tumor PD-L1 status, which was known for 75 patients, was not associated with response.\n\n“These detailed results confirm previous find...