- Bristol Myers Squibb (BMY, Financial) receives European Commission approval for Opdivo in treating high-risk NSCLC.
- Approval based on CheckMate -77T trial results showing a 42% reduction in disease progression risk.
- Opdivo is the only PD-(L)1 inhibitor approved in the EU for both perioperative and neoadjuvant treatments in NSCLC.
Bristol Myers Squibb (BMY) has announced that the European Commission has approved the use of Opdivo® (nivolumab) in combination with chemotherapy as a perioperative treatment for resectable, high-risk non-small cell lung cancer (NSCLC) in adult patients with PD-L1 expression ≥1%. The approval extends to 27 EU member states, Iceland, Liechtenstein, and Norway.
This decision comes after the successful results of the CheckMate -77T trial, which demonstrated that the Opdivo regimen significantly improved event-free survival (EFS) in comparison to neoadjuvant chemotherapy and placebo. Patients treated with Opdivo saw a 42% reduction in the risk of disease recurrence, progression, or death, with a hazard ratio of 0.58 and a 95% confidence interval ranging from 0.43 to 0.78.
The trial also highlighted a 65% event-free survival at 24 months for those in the Opdivo treatment arm versus 44% in the chemotherapy and placebo arm. Secondary endpoints such as pathologic complete response (pCR) and major pathologic response (MPR) showed clinically meaningful improvements. The safety profile observed was consistent with prior studies, and no new safety signals were identified.
With this approval, Opdivo becomes the only PD-(L)1 inhibitor available for both perioperative and neoadjuvant-only treatment of resectable NSCLC in Europe, offering a potentially transformative impact on treatment outcomes by reducing the risk of cancer recurrence early in the treatment process.
