Bristol Myers Squibb's Opdivo Demonstrates Overall Survival Benefit in Preoperative NSCLC Treatment

Bristol Myers Squibb (BMS) has announced a significant milestone for its immunotherapy drug Opdivo (nivolumab) in the treatment of non-small cell lung cancer (NSCLC). The pharmaceutical giant reported that Opdivo, when combined with platinum-doublet chemotherapy as a neoadjuvant treatment, has shown a statistically significant and clinically meaningful improvement in overall survival (OS) compared to chemotherapy alone in patients with resectable NSCLC.

CheckMate-816 Trial Results

The final analysis of the phase 3 CheckMate-816 study, which included 358 NSCLC patients with surgically removable tumors, revealed that the combination of Opdivo and chemotherapy before surgery extended patients' lives longer than chemotherapy alone. This trial focused on patients with tumors at least 4 cm in size or those that were node-positive.

Dr. Dana Walker, BMS's Opdivo lead, emphasized the significance of these results, stating, "This is the first and only phase 3 study of a neoadjuvant-only immuno-oncology therapy to show a statistically significant benefit in patients with resectable NSCLC."

The OS data builds upon previously reported positive outcomes from CheckMate-816, including improvements in event-free survival (EFS) and pathological complete response (pCR). These earlier results led to Opdivo's approval for this indication by the U.S. Food and Drug Administration (FDA) in March 2022.

Expanding Opdivo's Indications

Opdivo's success in the preoperative setting has solidified its position in the treatment paradigm for NSCLC. In October 2024, the FDA further expanded Opdivo's label to include its use as a monotherapy after surgery when the Opdivo and chemotherapy combination is used as a neoadjuvant treatment. This approval was based on data from the CheckMate-77T study.

With these approvals, Opdivo has distinguished itself as the only immunotherapy approved for use before surgery in resectable NSCLC. It joins AstraZeneca's Imfinzi and Merck's Keytruda in the perioperative setting, but remains unique in its preoperative indication.

Market Performance and Future Outlook

As Opdivo enters its second decade on the market, it continues to show strong performance. In 2024, the drug generated sales of $9.3 billion, representing a 3% increase from the previous year. However, BMS faces the challenge of Opdivo's approaching patent expiration, with exclusivity in the U.S. set to end in 2028.

The recent OS data and expanded indications are likely to bolster Opdivo's market position in the competitive immuno-oncology landscape. BMS has stated that comprehensive data from the CheckMate-816 trial will be released in a future peer-reviewed setting, which may further support the drug's use in early-stage NSCLC treatment.