New Jersey:  Bristol Myers Squibb has made significant strides in advancing the treatment landscape for resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) with the acceptance of two regulatory filings for neoadjuvant Opdivo (nivolumab) in combination with chemotherapy followed by surgery, and adjuvant Opdivo. This announcement marks a pivotal moment in the company's efforts to enhance patient outcomes in NSCLC.

The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics Application (sBLA) for neoadjuvant Opdivo and assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024. Meanwhile, the European Medicines Agency (EMA) recently validated the type II variation application, initiating the centralized review process for Opdivo's regulatory approval in Europe.

These submissions stem from the Phase 3 CheckMate -77T trial, which showcased promising results in improving event-free survival (EFS) – the primary endpoint of the study – among patients with resectable NSCLC. Additionally, secondary endpoints such as pathologic complete response (pCR) and major pathologic response (MPR) demonstrated notable benefits from the neoadjuvant Opdivo regimen. The safety profile observed in the trial remained consistent with previous studies in NSCLC, with no new safety concerns identified.

CheckMate -77T is a Phase 3 randomized, double-blind, placebo-controlled trial involving 452 patients. It evaluates the efficacy of neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo compared to neoadjuvant chemotherapy alone, followed by surgery and adjuvant placebo. The study aims to assess various endpoints including overall survival (OS), pCR, and MPR, with interim results presented at the European Society of Medical Oncology (ESMO) Congress 2023.

Bristol Myers Squibb remains committed to its mission of transforming patients' lives through scientific innovation. With a focus on cancer research, the company endeavors to develop medicines that offer patients better treatment options and potential cures. Leveraging its expertise in Immuno-Oncology, Bristol Myers Squibb conducts a robust global development program for Opdivo, encompassing clinical trials across different tumor types and phases.

Opdivo, the first PD-1 immune checkpoint inhibitor to receive regulatory approval globally in July 2014, is currently approved in over 65 countries, including major markets like the United States, European Union, Japan, and China. Furthermore, Opdivo in combination with Yervoy holds regulatory approvals in over 50 countries for the treatment of metastatic melanoma, marking a significant advancement in Immuno-Oncology therapy.

Through its innovative approach to cancer treatment and a commitment to scientific excellence, Bristol Myers Squibb continues to pave the way for improved outcomes and enhanced patient care in oncology.

Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb said, “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. 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 applications underscores 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.”

According to TechSci Research, the acceptance of regulatory filings for neoadjuvant Opdivo in combination with chemotherapy followed by surgery, and adjuvant Opdivo by Bristol Myers Squibb (BMY) signifies a significant development in the treatment landscape for resectable non-small cell lung cancer (NSCLC). This announcement has the potential to substantially impact the pharmaceutical market, particularly within the oncology sector. The acceptance of these filings by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) reflects regulatory recognition of Opdivo's efficacy and safety profile in treating NSCLC, which could bolster investor confidence in Bristol Myers Squibb's pipeline and future revenue projections.

Furthermore, the anticipated approval of Opdivo for this indication could result in a significant expansion of the drug's market share, as it would provide physicians with a novel and potentially more effective treatment option for patients with resectable NSCLC. This could lead to increased sales of Opdivo and potentially drive revenue growth for Bristol Myers Squibb in the coming years. Additionally, the positive outcomes from the Phase 3 CheckMate -77T trial and the potential approval of Opdivo for NSCLC may have broader implications for the competitive landscape of the oncology market, potentially prompting other pharmaceutical companies to explore similar combination therapies or invest further in immuno-oncology research.