Bristol-Myers Squibb (BMS; NYSE: BMY) announced last week that it has received marketing authorization from the European Commission (EC) for a perioperative regimen combining neoadjuvant Opdivo (nivolumab) plus chemotherapy, followed by surgery and adjuvant Opdivo monotherapy. This treatment is indicated for adults with resectable non-small cell lung cancer (NSCLC) who have PD-L1-positive tumors (expression ≥1%) and are at high risk of recurrence.
Clinical Trial Support
The approval is based on positive data from the CheckMate 77T trial. Compared to the control arm, which involved neoadjuvant platinum-based chemotherapy plus placebo followed by surgery and adjuvant placebo, the Opdivo-based regimen demonstrated a 42% reduction in the risk of disease recurrence, progression, or death (HR=0.58). It also significantly improved 24-month event-free survival (EFS) rates, achieving 65% versus 44% in the control group.-Fineline Info & Tech
