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Exelixis Announces Phase 1b Results from Cohort 6 of COSMIC-021 Trial in Patients with Metastatic Castration-Resistant Prostate Cancer
– The combination of cabozantinib and atezolizumab evaluated in cohort 6 of the COSMIC-021 phase 1b trial resulted in objective response rates of 27% and 18%
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– The combination of cabozantinib and atezolizumab evaluated in cohort 6 of the COSMIC-021 phase 1b trial resulted in objective response rates of 27% and 18% per investigator assessment and Blinded Independent Radiology Committee, respectively –\n\n– Exelixis intends to discuss the results with the U.S. FDA to determine next steps toward a regulatory submission for the combination regimen for patients with high-risk metastatic CRPC –\n\n– Phase 3 CONTACT-02 trial underway for metastatic CRPC –\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (NASDAQ: EXEL) today announced results from the metastatic castration-resistant prostate cancer (CRPC) cohort 6 of COSMIC-021, the phase 1b trial of cabozantinib (CABOMETYX®) in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. Cohort 6 included patients with metastatic CRPC who had been previously treated with enzalutamide and/or abiraterone acetate.\n\nUpon enrollment, patients had to have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1) per investigator assessment, had progressed on prior novel hormonal therapy, and could have received prior docetaxel for hormone-sensitive disease. The analysis included 132 patients, 101 of whom had high-risk disease, defined as measurable visceral and/or extra-pelvic lymph node metastases. The group with high-risk disease is the patient population for which Exelixis would pursue a U.S. regulatory filing. The median follow-up for the high-risk patients was 15.8 months. The primary endpoint was investigator-assessed objective response rate (ORR) per RECIST v. 1.1.\n\nIn the high-risk population, the investigator-assessed ORR was 27%, including 2% complete responses (CR) and 25% partial responses (PR). The Blinded Independent Radiology Committee (BIRC)-assessed ORR was 18%, all of which were partial responses. The disease control rate (CR + PR + stable disease) was 88% and 84% per investigator and BIRC assessment, respectively. Other radiographic endpoints, namely progression-free survival and duration of response, were similar between the investigator and BIRC assessment. Detailed results of the trial will be presented at a medical meeting in the second half of 2021.\n\nAn interim analysis of the initial 44 patients enrolled in the cohort was previously presented at the 20...