Hot on the tail of AstraZeneca’s Imfinzi, Bristol Myers Squibb’s PD-1/L1 inhibitor Opdivo has expanded its non-small cell lung cancer (NSCLC) net with an FDA nod to be used alongside chemotherapy before surgery and as a monotherapy after surgery in certain patients with resectable NSCLC.
The drug regimen was specifically cleared to treat adults with resectable NSCLC who have no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
In the company’s CHECKMATE 77T study, the Opdivo regimen significantly reduced the risk of tumor recurrence, progression or death in patients with early-stage NCSLC against the study's control arm. That trial compared the Opdivo regimen to pre-surgery chemotherapy, followed by surgery and placebo.
Opdivo previously won the title of the first pre-surgery therapy, or neoadjuvant therapy, for early-stage NSCLC in 2022 after a speedy five-day FDA review. In that setting, Opdivo alongside chemo reduced the risk of disease recurrence, progression or death by 37% compared to chemo alone, BMS found in its CHECKMATE 816 study.
“This milestone expands the role of Opdivo-based treatments and builds upon the foundation set by the FDA approval of neoadjuvant-only Opdivo plus chemotherapy in resectable NSCLC based on the CheckMate-816 trial,” the company’s senior vice president of U.S. oncology and hematology, Wendy Short Bartie, said in a statement. “With this new Opdivo-based regimen, we are reinforcing our commitment to helping improve patient outcomes and expanding our early-stage disease thoracic portfolio.”
With the new nod, Opdivo joins formidable competitors such as AstraZeneca’s Imfinzi in the early-stage NSCLC perioperative treatment landscape. The AZ PD-L1 drug beat Opdivo to the chase with its August approval, which came after an advisory committee debated over Imfinzi’s phase 3 trial design.
Before Imfinzi, Merck’s oncology superstar Keytruda secured the same approval last October.
Still, Opdivo’s latest nod makes it the only PD-1 inhibitor cleared to treat resectable NSCLC as both a neoadjuvant-only regimen and as part of a perioperative treatment regimen. Some 30% to 50% of patients with resectable NSCLC can develop recurrence post-surgery, meaning a therapy that can be administered before and after surgery could provide added treatment flexibility.
This year, BMS celebrated the 10th anniversary of Opdivo's initial approval, and the medicine still serves as a major sales driver. In 2023, the drug pulled in $9 billion in worldwide sales.