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Exelixis and Ipsen Announce Positive Results from Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer
– Cabozantinib in combination with atezolizumab demonstrated a statistically significant reduction in the risk of disease progression or death compared with
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– Cabozantinib in combination with atezolizumab demonstrated a statistically significant reduction in the risk of disease progression or death compared with a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer –\n\n\n– A trend toward improvement in overall survival was observed at first interim analysis –\n\n\n– Findings will be presented at an upcoming medical meeting and discussed with health authorities globally –\n\n\n ALAMEDA, Calif. & PARIS--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the global phase 3 CONTACT-02 pivotal trial met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival (PFS) at the primary analysis. CONTACT-02 is evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab compared with a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable soft tissue disease who have been previously treated with one novel hormonal therapy. At a prespecified interim analysis for the primary endpoint of overall survival (OS) that occurred at the same time as the primary analysis of PFS, a trend toward improvement of OS was observed; however, the data were immature and did not meet the threshold for statistical significance. Therefore, the trial will continue to the next analysis of OS as planned.\n\n\nThe safety profile of the combination of cabozantinib and atezolizumab was consistent with the known safety profiles for each single medicine, and no new safety signals were identified with the combination.\n\n\n“These positive findings from CONTACT-02 are highly encouraging given the need for additional, non-cytotoxic or non-chemotherapeutic treatment options for this patient population,” said Neeraj Agarwal, M.D., FASCO, Professor and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, University of Utah and the global lead investigator of the trial. “Cabozantinib in combination with atezolizumab represents a potential new treatment modality for patients with metastatic castration-resistant prostate cancer, and we look forward to sharing the full data at a future medical meeting.”\n\n\n“Patients with metastatic castration-resistant prostate cancer face a poor pro...