FDA approval gives BMS an edge in NSCLC treatment

Bristol Myers Squibb (BMS) has secured another win for Opdivo (nivolumab), becoming the only FDA-approved PD-1 inhibitor for resectable non-small cell lung cancer NSCLC in both a neoadjuvant-only regimen and as part of a perioperative treatment regimen in the US.

This approval covers the combination of neoadjuvant Opdivo with chemotherapy, followed by surgery and adjuvant Opdivo monotherapy, providing a treatment option that extends from initial diagnosis to post-surgical care.

Lung cancer is the leading cause of cancer-related deaths in the United States, with NSCLC accounting for up to 85% of diagnoses. While surgery has been a primary treatment option for some early-stage NSCLC patients, recurrence rates of 30% to 55% highlight the need for additional perioperative interventions.

“Given the rates of disease recurrence in patients with resectable NSCLC, there is a clear need for options that can be administered before and after surgery that may target micrometastasis, help reduce the risk of cancer returning and improve the chance of successful surgical treatment," said Dr Tina Cascone, associate professor of thoracic/head and neck medical oncology at The University of Texas MD Anderson Cancer Center.

The FDA based its decision on results from the Phase 3 CheckMate -77T trial, which showed improved event-free survival (EFS) for patients receiving the Opdivo-based regimen compared to chemotherapy alone. Results of the study showed that patients in the Opvido arm had a 42% reduction in the risk of disease recurrence, progression, or mortality. At 18 months, 70% of participants receiving Opdivo demonstrated EFS, compared to 50% in the control arm.

The approval of this Opdivo-based regimen expands Bristol Myers Squibb's thoracic portfolio in early-stage disease. Wendy Short Bartie, senior vice president of US oncology and haematology at BMS, stated, "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. With this new Opdivo-based regimen, we are reinforcing our commitment to helping improve patient outcomes and expanding our thoracic portfolio in early-stage disease."

This approval adds to Opdivo's existing indications across various cancer types and stages. The immunotherapy has been used in the treatment of advanced or metastatic NSCLC, and its application in earlier stages of lung cancer may contribute to improving surgical outcomes and reducing relapse rates.

In 2023, BMS received a similar approval across the pond. The National Institute for Health and Care Excellence (NICE) cleared Opdivo (nivolumab) for use with platinum-based chemo to reduce the size of NSCLC tumours before surgery, and reduce the chances of disease recurrence.