Bristol Myers Squibb Receives EC Approval for Opdivo-Based Perioperative Regimen in Early-Stage NSCLC
Saturday, May 17, 2025
Bristol Myers Squibb has received approval from the European Commission for a perioperative treatment regimen involving Opdivo® (nivolumab) and chemotherapy before surgery, followed by adjuvant Opdivo monotherapy, for adult patients with resectable non-small cell lung cancer (NSCLC) whose tumours express PD-L1 ≥1%.
Opdivo is a PD-1 immune checkpoint inhibitor that works by enhancing the body’s natural immune response against cancer. It is already approved for use across several cancer types in the EU. The current EC approval builds on earlier authorisation by the U.S. FDA in October 2024, which also used data from the CheckMate -77T trial to support its decision.
Non-small cell lung cancer is one of the most prevalent forms of lung cancer globally and accounts for around 84% of cases. While many cases can be treated with surgery, recurrence remains common. Perioperative treatment options are therefore seen as an important step towards improving survival rates in early-stage disease.
Opdivo has been approved in more than 65 countries worldwide and is part of a broad clinical development programme by Bristol Myers Squibb, which continues to explore its use across a range of cancers and patient populations.
The approval applies to all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway, offering a new treatment option for patients at high risk of disease recurrence.
This treatment is intended for patients at high risk of recurrence and aims to improve long-term outcomes by reducing the likelihood of the cancer returning after surgery. The decision follows findings from the Phase 3 CheckMate -77T trial, which showed that the Opdivo-based regimen significantly improved event-free survival (EFS) compared to chemotherapy alone.
In the study, patients receiving Opdivo plus chemotherapy before surgery, followed by adjuvant Opdivo, had a 42% lower risk of disease recurrence, progression, or death. After a median follow-up of 25.4 months, 65% of patients in the Opdivo group remained event-free at 24 months, compared to 44% in the control group. The trial also showed better outcomes in terms of pathologic complete response (pCR) and major pathologic response (MPR).
The safety profile of the regimen was consistent with previous studies in NSCLC, and no new safety issues were reported. The CheckMate -77T trial continues to evaluate overall survival as a key secondary endpoint.
Source: bms.com
