BMS Gets FDA Approval for Opdivo in NSCLC

The FDA has recently approved the use of Bristol Myers Squibb’s (BMS) PD-1 inhibitor, Opdivo, as a perioperative treatment for patients with resectable non-small cell lung cancer (NSCLC). This new approval specifically targets NSCLC patients who do not have known EGFR mutations or ALK rearrangements. The treatment involves using Opdivo in combination with platinum-doublet chemotherapy prior to surgery and continuing with Opdivo as monotherapy after the surgery. With this approval, Opdivo is the only PD-1 inhibitor sanctioned for both neoadjuvant-only and perioperative use for resectable NSCLC.

Tina Cascone, an associate professor of thoracic/head and neck medical oncology at The University of Texas MD Anderson Cancer Center, described this approval as a significant advancement for patients with resectable NSCLC. She emphasized the importance of having treatment options that can be administered both before and after surgery to decrease the likelihood of cancer recurrence and to improve the success rate of surgical interventions. Cascone has had financial ties with BMS in the past, including research grants and contract support, and she was also the recipient of BMS' Oncology Scholar in Training Award in 2010.

The FDA’s approval of this perioperative regimen was based on data from the CheckMate-77T study. This Phase III clinical trial was randomized, double-blinded, and placebo-controlled and included over 450 NSCLC patients. It compared the effectiveness of the perioperative Opdivo regimen with neoadjuvant platinum-doublet chemotherapy followed by surgery and adjuvant placebo. Findings from the study, which were publicized in October 2023, indicated that the Opdivo regimen led to a significantly better event-free survival (EFS), reducing the risk of recurrence, progression, or death by 42% as compared to the control group. Follow-up data at 18 months showed that 70% of patients in the Opdivo group had EFS, in contrast to only 50% in the control group.

Opdivo, known for its role in blocking cancer cells from suppressing the immune system, has already received multiple approvals for NSCLC. These include its use as a frontline therapy in conjunction with Yervoy and as a neoadjuvant treatment with platinum-doublet chemotherapy. Beyond NSCLC, Opdivo is approved for treating several other cancers, including melanoma, renal cell carcinoma, and colorectal cancer.

This recent approval comes at a time when the FDA has been scrutinizing the overall benefit of using PD-1 inhibitors both before and after surgery in NSCLC. The FDA, in a document released in July 2024, expressed concerns about the potential for overtreatment with such perioperative regimens. The agency highlighted the importance of understanding the specific benefits contributed by each phase of the treatment to prevent unnecessary exposure to treatments and associated risks. The FDA’s Oncologic Drugs Advisory Committee supported this viewpoint, advocating for changes in the design of clinical trials for perioperative treatments in NSCLC.