Perioperative regimen of neoadjuvant Opdivo, chemotherapy improves event free survival in Resectable Non-Small Cell Lung Cancer: Bristol Myers Squibb
Princeton: Bristol Myers Squibb has announced the Phase 3 CheckMate -77T trial has met its primary endpoint of improved event-free survival (EFS) as assessed by Blinded Independent Central Review (BICR) in patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). In a prespecified interim analysis, the perioperative regimen of neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo showed a statistically significant and clinically meaningful improvement in EFS compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo. The safety profile of this Opdivo-based regimen was consistent with previously reported studies in NSCLC.
“We’ve seen tremendous scientific advancements in the treatment of non-metastatic non-small cell lung cancer in recent years, and remain committed to researching new solutions that may help even more patients achieve better long-term outcomes,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. “Taken together with the data from our CheckMate -816 trial - which led to Opdivo being the only anti-PD-1 with an approval in the neoadjuvant setting - these results reinforce our leadership in resectable non-small cell lung cancer and add to our legacy of transformational science in thoracic cancers. We thank the patients and investigators involved in the trial who have allowed us to advance our understanding of the importance of immunotherapy in treating patients’ cancer in earlier stages.”
The company will complete a full evaluation of the available data from CheckMate -77T and looks forward to sharing the results with the scientific community at an upcoming medical conference as well as discussing with health authorities. The trial is currently ongoing to assess overall survival (OS), a secondary endpoint.
To date, Opdivo and Opdivo-based combinations have shown improved efficacy in the neoadjuvant, adjuvant or perioperative treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
