![]() The company will complete a full evaluation of the available CheckMate -816 data and looks forward to sharing the results at an upcoming medical conference, as well as with health authorities. “The event-free survival data from CheckMate -816 strengthen the evidence for the potential of Opdivo-based therapies to improve long-term clinical outcomes when used in the earlier stages of non-metastatic cancers.” The combination of Opdivo plus chemotherapy first showed a statistically significant improvement in pathologic complete response rate without impacting surgical outcomes and has now extended the time patients live free of disease progression, recurrence or death,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “CheckMate -816 is the first Phase 3 trial with an immunotherapy-based combination to demonstrate a statistically significant and clinically meaningful benefit as a neoadjuvant treatment for patients with non-metastatic non-small cell lung cancer. “The positive event-free survival data seen with neoadjuvant nivolumab plus chemotherapy is groundbreaking and can have important implications for how we treat resectable non-small cell lung cancer.” “While the intent of surgery is curative in resectable non-small cell lung cancer, between 30% to 55% of patients experience recurrence after surgery and ultimately succumb to the disease, presenting a strong need for additional options that can disrupt this cycle,” said Nicolas Girard, M.D., Ph.D., professor of respiratory medicine at Paris Saclay University and head of the Thorax Institute Curie Montsouris in Paris. ![]() The safety profile of Opdivo plus chemotherapy was consistent with previously reported studies in NSCLC. This combination previously showed a significant improvement of pathologic complete response (pCR), the trial’s other primary endpoint. In a prespecified interim analysis, Opdivo (nivolumab) plus chemotherapy showed a statistically significant and clinically meaningful improvement in EFS compared to chemotherapy alone when given before surgery. Positive results reinforce the improved efficacy seen with Opdivo -based treatments in four Phase 3 clinical trials in earlier-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanomaīristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -816 trial met the primary endpoint of improved event-free survival (EFS) in patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC). CheckMate -816 is the first Phase 3 trial with an immunotherapy-based combination to demonstrate improved event-free survival and pathologic complete response in the neoadjuvant setting of non-small cell lung cancer
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