EU CommissionApproves Perioperative Opdivo Regimen for High-Risk Resectable NSCLC

The European Commission has approved a perioperative regimen of Bristol Myers Squibb’s immunotherapy drug Opdivo® (nivolumab) for adults with resectable, high-risk non-small cell lung cancer (NSCLC) exhibiting PD-L1 expression ≥1%. The decision positions Opdivo as the only PD-(L)1 inhibitor currently authorized in the European Union for both perioperative and neoadjuvant-only treatment in this setting—a distinction that reflects a growing consensus around earlier immunotherapy intervention in curative-intent lung cancer.

This approval hinges on the results of the Phase 3 CheckMate-77T trial, a multi-center, randomized study that evaluated the addition of neoadjuvant Opdivo to platinum-based chemotherapy, followed by surgery and continued adjuvant Opdivo monotherapy. The results are striking: the Opdivo-based regimen reduced the risk of disease recurrence, progression, or death by 42% compared to chemotherapy and placebo (EFS HR 0.58; 95% CI: 0.43–0.78; P = 0.00025) after a median follow-up of just over two years.

Event-free survival (EFS)—a critical benchmark in early-stage lung cancer—was preserved at 24 months in 65% of patients receiving Opdivo, compared with only 44% in the control group. These outcomes underscore the growing potential of immunotherapy to alter the natural history of resectable NSCLC when introduced earlier in the disease course.

“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 Dr. Dana Walker, Vice President and global program lead for Opdivo at Bristol Myers Squibb.

Beyond EFS, the CheckMate-77T study also showed meaningful improvements in pathologic complete response (pCR) and major pathologic response (MPR), two surrogate markers that are increasingly recognized for their prognostic value in perioperative trials. Importantly, the benefits of the regimen were consistent across all randomized subgroups, and the safety profile aligned with earlier data—offering reassurance that this intensified approach is both effective and tolerable.

Opdivo’s earlier approval as a neoadjuvant-only option already signaled a paradigm shift. The expanded perioperative regimen builds on this momentum, aiming not only to shrink tumors pre-surgery but also to sustain immune activation post-resection, when microscopic disease remains a looming threat.

Implications for European Practice

This EC approval is applicable across all 27 EU member states, along with Iceland, Liechtenstein, and Norway, broadening access to this new treatment paradigm.

Moreover, the approval aligns Europe with regulatory momentum in the United States, where the FDA approved the same regimen in October 2024 for adult patients with resectable NSCLC (tumors ≥4 cm or node-positive), excluding those with known EGFR or ALK alterations.