Opdivo’s approval for patients with resectable non-small cell lung cancer comes as the regulator recently raised concerns of overtreatment with this type of therapeutic regimen with platinum-doublet chemotherapy.
The FDA on Thursday signed off on a perioperative treatment regimen of Bristol Myers Squibb’s PD-1 inhibitor Opdivo for patients with resectable non-small cell lung cancer.
The approval covers non-small cell lung cancer (NSCLC) patients without known EGFR mutations or ALK rearrangements. In these patients, Opdivo can now be used with platinum-doublet chemotherapy before surgery, followed by adjuvant Opdivo monotherapy after the operation. According to BMS, Opdivo is so far the only PD-1 inhibitor approved both in the neoadjuvant-only setting and as part of a perioperative regimen for resectable NSCLC.
Tina Cascone, associate professor of thoracic/head and neck medical oncology at The University of Texas MD Anderson Cancer Center, in a statement called Thursday’s approval a “step forward” for patients with resectable NSCLC for whom “there is a clear need for options that can be administered before and after surgery” to help reduce the risk of recurrence and boost their chances of successful surgical treatment.
Cascone has previously reported financial relationships with BMS, including research grant and contract support. In 2010, she won BMS’ Oncology Scholar in Training Award.
Opdivo’s perioperative approval was supported by data from the CheckMate- 77T study, a randomized, double-blinded and placebo-controlled Phase III trial that enrolled more than 450 NSCLC patients. The study compared the perioperative Opdivo regimen against neoadjuvant platinum-doublet chemotherapy, followed by surgery and then adjuvant placebo.
Findings, which were first made public in October 2023, showed that the Opdivo regimen demonstrated significantly superior event-free survival (EFS), cutting the risk of recurrence, progression or death by 42% versus chemotherapy and placebo. In addition, at 18 months of follow-up, EFS was documented in 70% of patients in the Opdivo group, compared with only 50% in the control group.
Opdivo, a PD-1 inhibitor that blocks cancer cells’ ability to suppress the immune response, has previously won other approvals for NSCLC, including as frontline therapy with Yervoy and as a neoadjuvant combo with platinum-doublet chemotherapy. Opdivo is also approved for other cancers, such as melanoma, renal cell carcinoma and colorectal cancer.
Thursday’s regulatory win for Opdivo comes as the FDA has questioned the therapeutic value of administering PD-1 inhibitors both before and after surgery in NSCLC. In a briefing document released in July 2024, the regulator’s staffers flagged the risk of “potential overtreatment” with a perioperative regimen, noting that there is a need to know for certain which phase of treatment contributes what benefit. Otherwise, the FDA contends patients are at risk of being exposed to excessive treatments and their associated safety risks.
The FDA’s Oncologic Drugs Advisory Committee agreed with the regulator, unanimously backing the need for changes in clinical trial designs for perioperative treatments in NSCLC.
