Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo^® (nivolumab), in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment after surgical resection for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%. The CHMP adopted a positive opinion based on results from the CheckMate -77T trial, in which the perioperative regimen of neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

“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,” said Dana Walker, M.D., M.S.C.E., vice president, Opdivo global program lead, Bristol Myers Squibb. “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.”

The CheckMate -77T trial also demonstrated clinically meaningful improvements in the secondary efficacy endpoints of pathologic complete response (pCR) and major pathologic response (MPR). The safety profile of the perioperative regimen was consistent with previously reported studies in NSCLC. The EFS, pCR and MPR results from the CheckMate -77T trial were first presented at the European Society of Medical Oncology (ESMO) Congress 2023 and published in The New England Journal of Medicine . CheckMate -77T is ongoing to assess another key secondary endpoint of overall survival (OS).

In October 2024, the CheckMate -77T trial was used as the basis for the U.S. Food and Drug Administration’s (FDA) approval of Opdivo for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery.

CheckMate -77T represents the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable non-metastatic NSCLC. Opdivo is the only immunotherapy treatment with Phase 3 data in both the neoadjuvant only and perioperative NSCLC treatment setting. In addition, Opdivo and Opdivo -based combinations have shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

In the EU, the EC delivers its final decision within approximately two months following receipt of the CHMP opinion. Once issued, the decision will be applicable to all EU member states as well as in the European Economic Area (EEA) countries Iceland, Norway and Liechtenstein.