On February 7, 2024 Bristol Myers Squibb (NYSE: BMY) reported two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) (Press release, Bristol-Myers Squibb, FEB 7, 2024, View Source [SID1234639906]). The U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics Application (sBLA) and assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024. In late January, the European Medicines Agency (EMA) validated the type II variation application which confirms the submission is complete and begins the start of the EMA’s centralized review process.

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"Between 30% to 55% of non-small cell lung cancer patients who undergo surgery will experience disease recurrence. We are working to expand options that improve outcomes for patients with resectable disease, as part of our comprehensive approach to the treatment of multiple types of cancer, including and especially in earlier stages," said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. "With CheckMate -77T, we have evaluated the potential for neoadjuvant immunotherapy to induce pathological complete response and the role of perioperative Opdivo treatment in reducing the likelihood that the cancer will return and help make extended survival possible for patients. The acceptance of these applicationsunderscores our impactful progress in addressing unmet needs across several non-small cell lung cancer treatment settings and brings us one step closer to offering a new perioperative Opdivo-based regimen to patients who may benefit."

The submissions were based on results from the Phase 3 CheckMate -77T trial, which represents the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC, showing statistically significant and clinically meaningful improvements in event-free survival (EFS), the study’s primary endpoint. The study also showed benefits in key secondary endpoints including pathologic complete response (pCR) and major pathologic response (MPR). Additionally, the perioperative regimen had a safety profile consistent with previously reported studies in NSCLC and no new safety signals were identified. The EFS, pCR and MPR results from CheckMate -77T were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023. The study remains ongoing to assess another secondary endpoint of overall survival (OS).

Opdivo and Opdivo-based combinations have shown efficacy benefits in the neoadjuvant, adjuvant or perioperative settings across four cancers to date, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

About CheckMate -77T
CheckMate -77T is a Phase 3 randomized, double-blind, placebo-controlled, multi-center trial evaluating neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo versus neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo in 452 patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The primary endpoint of the trial is event-free survival (EFS). Secondary endpoints include overall survival (OS), pathologic complete response (pCR) and major pathologic response (MPR).

About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%, with up to half of these being resectable), and the proportion is expected to grow over time with enhanced screening programs. While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.