BMS Gets CHMP Nod for Opdivo-Based Perioperative Regimen in Resectable NSCLC
Bristol Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opdivo® (nivolumab) for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. The recommendation is based on a perioperative regimen involving Opdivo in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo monotherapy as adjuvant treatment post-surgery. This regimen is specifically indicated for adult patients whose tumors exhibit PD-L1 expression ≥1%.
The CHMP’s recommendation follows the results of the CheckMate -77T clinical trial, which demonstrated that the perioperative regimen significantly improved event-free survival (EFS), the study’s primary endpoint. The trial results showed both statistical significance and clinical relevance, strengthening the case for Opdivo’s approval in this indication. The European Commission (EC) will now review CHMP’s recommendation before issuing a final decision regarding approval within the European Union (EU).
Addressing an Urgent Need in NSCLC Treatment
Dana Walker, M.D., M.S.C.E., vice president and global program lead for Opdivo at Bristol Myers Squibb, emphasized the importance of this advancement, stating: “Preventing disease recurrence and improving long-term outcomes for patients with NSCLC earlier in the treatment journey is critical to addressing unmet needs and is one of our top priorities. With today’s positive opinion from the CHMP, we are pleased that our second Opdivo-based regimen for certain patients with resectable NSCLC whose tumors have PD-L1 expression ≥1% is one step closer to being approved in the European Union.”
Bristol Myers Squibb has been at the forefront of immunotherapy research, and the CHMP’s positive opinion marks a critical milestone in advancing treatment options for NSCLC patients. By integrating Opdivo both before and after surgery, the company aims to enhance patient outcomes by reducing the likelihood of disease recurrence.
Clinical Data Supporting Approval
The CheckMate -77T trial provided compelling evidence supporting the use of this perioperative regimen. In addition to demonstrating significant improvements in EFS, the trial also showed clinically meaningful benefits in secondary endpoints such as pathologic complete response (pCR) and major pathologic response (MPR). These results indicate that the treatment not only prolongs survival without disease progression but also reduces the tumor burden significantly before surgery.
The safety profile observed in CheckMate -77T was consistent with previous studies evaluating Opdivo in NSCLC. The trial findings were first presented at the European Society of Medical Oncology (ESMO) Congress 2023 and later published in The New England Journal of Medicine. The trial remains ongoing to further assess another key secondary endpoint—overall survival (OS).
Regulatory and Clinical Milestones
Opdivo has already received approval in the United States for this specific treatment regimen. In October 2024, the U.S. Food and Drug Administration (FDA) approved Opdivo for adult patients with resectable (tumors ≥4 cm or node-positive) NSCLC who do not have known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. This approval was also based on the CheckMate -77T trial results, demonstrating the robust evidence supporting this treatment approach.
CheckMate -77T represents Bristol Myers Squibb’s second successful Phase 3 randomized trial evaluating an immunotherapy-based regimen in resectable non-metastatic NSCLC. The company continues to lead the field in developing innovative cancer therapies, with Opdivo emerging as the only immunotherapy with Phase 3 data supporting both neoadjuvant-only and perioperative treatment settings for NSCLC.
Beyond lung cancer, Opdivo and Opdivo-based combinations have demonstrated efficacy in the neoadjuvant and adjuvant treatment of multiple tumor types, including bladder cancer, esophageal/gastroesophageal junction cancer, and melanoma. These findings underscore the broad applicability of Opdivo in treating various forms of cancer.
Next Steps: EU Approval Process
Following CHMP’s positive opinion, the European Commission (EC) will now conduct its formal review before making a final decision on the approval of Opdivo’s perioperative regimen. The EC generally issues decisions within approximately two months of receiving CHMP recommendations. If approved, this decision will apply across all EU member states as well as European Economic Area (EEA) countries, including Iceland, Norway, and Liechtenstein.
Bristol Myers Squibb’s commitment to advancing cancer immunotherapy is reflected in its continued investment in clinical research and regulatory efforts worldwide. If granted EU approval, this new Opdivo-based treatment regimen has the potential to improve survival and quality of life for many NSCLC patients at high risk of recurrence.
