The U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for treating adults with resectable non-small cell lung cancer (NSCLC). The regimen combines neoadjuvant therapy with platinum-doublet chemotherapy followed by adjuvant Opdivo treatment after surgery.
The approval stems from the CheckMate-77T trial, where the Opdivo-based regimen significantly extended event-free survival compared to chemotherapy and placebo. The trial also demonstrated a high pathologic complete response rate.
Opdivo is the only PD-1 inhibitor approved for resectable NSCLC in both a neoadjuvant-only setting and as part of a perioperative treatment regimen. This signifies a milestone in Bristol Myers Squibb’s thoracic portfolio and reinforces its commitment to advancing treatments for patients with early-stage disease.
The CheckMate-77T trial compared the perioperative regimen (Opdivo with neoadjuvant chemotherapy followed by adjuvant Opdivo) to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo. The Opdivo arm demonstrated a 42% reduction in disease recurrence risk, and 18-month event-free survival rates were significantly higher in the Opdivo arm than in the chemotherapy and placebo arm. Additionally, 25% of patients in the Opdivo arm achieved a complete pathologic response.
The FDA approval of Opdivo for resectable NSCLC provides a valuable treatment option for patients, offering improved outcomes and reducing the risk of recurrence post-surgery.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
