We thank the patients, investigators and all site personnel involved in the CheckMate -901 trial.” “We are encouraged by these positive results and remain steadfast in our commitment to bringing new solutions to patients with high unmet needs. Opdivo with cisplatin-based chemotherapy is the first immunotherapy-based combination to improve both overall survival and progression-free survival in patients with previously untreated unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy, reinforcing the benefits of Opdivo-based treatments seen across a variety of genitourinary cancers, including durable survival in advanced renal cell carcinoma and a reduced risk of recurrence in resectable muscle-invasive urothelial carcinoma,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, genitourinary cancers, Bristol Myers Squibb. “Today’s news is yet another example of the power of immunotherapy combinations to transform outcomes for patients with cancer. No new safety concerns have been identified. The combination of Opdivo with cisplatin-based chemotherapy in first-line urothelial carcinoma had a tolerable safety profile consistent with the known safety profiles of the individual components of the regimen. Results of the sub-study showed that Opdivo (nivolumab) in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant benefits in OS and PFS compared to standard-of-care cisplatin-based combinations as a first-line treatment for patients with unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy. PRINCETON, N.J.-(BUSINESS WIRE)- Bristol Myers Squibb (NYSE: BMY) today announced that the sub-study of the Phase 3 CheckMate -901 trial met the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) at final analysis. CheckMate -901 is the first and only Phase 3 trial with an immunotherapy-based combination to demonstrate a survival benefit compared to standard-of-care cisplatin-based combinations in the first-line treatment of this patient population
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