Bristol Myers Squibb bags European Commission approval for Opdivo combo in lung cancer treatment

“This approval brings another perioperative immunotherapy treatment option for select patients with resectable NSCLC in the EU, helping address an ongoing need for interventions that can meaningfully reduce the risk of cancer returning after initial therapy,” said Dana Walker, M.D., M.S.C.E., vice president, Opdivo global program lead, Bristol Myers Squibb. “With this approval, Opdivo with chemotherapy followed by adjuvant Opdivo has the potential to change the course of certain patients’ disease by significantly reducing the risk of cancer recurrence and improving long-term outcomes earlier in the treatment journey.”

The decision is based on results from the CheckMate -77T study, which evaluated the perioperative regimen of neoadjuvant Opdivo with platinum-doublet chemotherapy followed by surgery and adjuvant Opdivo monotherapy, compared to neoadjuvant platinum-doublet chemotherapy and placebo followed by surgery and adjuvant placebo in adult patients with resectable NSCLC. The trial met its primary endpoint of event-free survival (EFS), showing that the risk of disease recurrence, progression or death was reduced by 42% (EFS Hazard Ratio [HR] 0.58; 95% Confidence Interval [CI]: 0.43 to 0.78; P=0.00025) in patients treated in the Opdivo arm, compared to the chemotherapy and placebo arm, after a median follow-up of 25.4 months. Furthermore, after 24–months, EFS was observed in 65% of patients in the Opdivo arm, compared to 44% of patients in the chemotherapy and placebo arm. The trial also demonstrated clinically meaningful improvements in the secondary efficacy endpoints of pathologic complete response (pCR) and major pathologic response (MPR). The regimen benefit was demonstrated across all efficacy endpoints and in all randomized subjects. Additionally, the safety profile of the perioperative regimen was consistent with previously reported studies in NSCLC. No new safety signals were identified.

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. Updated results were presented at the ESMO Congress 2024. CheckMate -77T is ongoing to assess the key secondary endpoint of overall survival (OS).

This approval by the EC for the treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1% is valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway. In addition to approvals in lung cancer, Opdivo-based options are also approved for treatment of multiple tumor types in the EU.

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.

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.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.