Bristol Myers Squibb has bolstered its case for Opdivo to be used as a preoperative treatment for non-small cell lung cancer (NSCLC) as it has delivered an overall survival (OS) edge when added to chemotherapy.

In the final analysis of the phase 3 CheckMate-816 study, Opdivo plus platinum-doublet chemotherapy as a neoadjuvant (before surgery) regimen kept patients alive longer than chemo alone. The trial included 358 NSCLC patients with tumors that can be removed via surgery—those that are at least 4 cm or are node-positive.

With OS as a secondary endpoint of the study, the couplet showed statistically significant and clinically meaningful improvement versus chemotherapy alone.

BMS said it will release comprehensive data in a “future peer-reviewed setting.”

“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,” Dana Walker, M.D., BMS’s Opdivo lead, said in a release.

The result builds on the CheckMate-816 trial achieving its primary endpoints of event-free survival (EVS) and pathological complete response (pCR), which paved the way for Opdivo to gain approval in the indication in March 2022.

The trial showed that Opdivo alongside chemo reduced the risk of disease recurrence, progression or death by 37% compared to chemo alone. The results were so convincing that the FDA took just five days after accepting BMS’s application to give it a thumbs up. It was endorsed for patients with resectable NSCLC who have no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Then in October of last year, the FDA tacked on another nod for Opdivo to also be used as a monotherapy after surgery when the Opdivo and chemo regimen are used as a neoadjuvant. The nod was facilitated by the CheckMate-77T study provided to patients post-surgery with Opdivo as a monotherapy or placebo.

With the October approval, Opdivo became the third immuno-oncology treatment to gain a nod for perioperative use, joining AstraZeneca’s Imfinzi and Merck’s Keytruda. Opdivo however remains the only one that can be used before surgery. 

Now entering its second decade on the market, Opdivo generated sales of $9.3 billion last year, which was a 3% increase from 2023. Opdivo is expected to lose its exclusivity in the U.S. in 2028.