Bristol Myers Squibb announced that the European Commission (EC) has approved a new perioperative treatment regimen for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. The approved regimen includes neoadjuvant Opdivo® (nivolumab) with chemotherapy, followed by surgery and adjuvant Opdivo monotherapy, for adult patients whose tumors express PD-L1 ≥1%.
“This approval introduces another perioperative immunotherapy option for select NSCLC patients in the EU, helping reduce the risk of recurrence and improve long-term outcomes,” said Dr. Dana Walker, vice president and global program lead for Opdivo at Bristol Myers Squibb.
The EC’s decision is based on the results of the Phase 3 CheckMate -77T study. The trial evaluated the effectiveness of Opdivo combined with platinum-doublet chemotherapy before surgery, followed by adjuvant Opdivo monotherapy, compared to a placebo regimen. The study met its primary endpoint of event-free survival (EFS), with a 42% reduction in the risk of recurrence, progression, or death (EFS Hazard Ratio 0.58; 95% CI: 0.43–0.78; P=0.00025). After a median follow-up of 25.4 months, 65% of patients in the Opdivo arm remained event-free at 24 months, compared to 44% in the placebo arm.
The trial also showed significant improvements in key secondary endpoints, including pathologic complete response (pCR) and major pathologic response (MPR). Benefits were consistent across all efficacy endpoints and treatment groups. The safety profile was in line with previous NSCLC studies, with no new safety concerns identified.
The EFS, pCR, and MPR data were first presented at the ESMO Congress 2023 and published in The New England Journal of Medicine, with updated findings shared at ESMO Congress 2024. The trial is ongoing to assess overall survival (OS) as a key secondary endpoint.
This EC approval is valid across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. The FDA also approved the Opdivo-based regimen in October 2024 for use in the U.S., based on CheckMate -77T results. Opdivo is currently approved in the EU for various cancers beyond NSCLC.