BMS’ Opdivo is said to be the only PD-1 inhibitor to demonstrate an advantage over chemotherapy, both presurgery and in a perioperative setting. Credit: HJBC via Shutterstock.

Bristol Myers Squibb (BMS) has received approval from the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

These adult patients have no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.

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The approval covers the use of Opdivo as a neoadjuvant treatment in combination with platinum-doublet chemotherapy, followed by the therapy as a single-agent adjuvant treatment post-surgery.

It is based on the results from the Phase III CheckMate-77T trial. It is the second positive trial for an immunotherapy-based combination in treating resectable NSCLC.

Opdivo is now the sole programmed cell death protein 1 (PL-1) inhibitor proven to benefit patients compared to chemotherapy, both as a neoadjuvant regimen and within a perioperative framework.

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BMS US Oncology and Hematology senior vice-president Wendy Short Bartie said: “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.

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“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.”

The CheckMate-77T trial compared the Opdivo regimen with a control arm receiving platinum-doublet chemotherapy and placebo.

The study demonstrated a 42% reduction in the risk of disease recurrence, progression, or mortality in the Opdivo arm, with an event-free survival (EFS) hazard ratio of 0.58.

At 18 months, 70% of subjects in the Opdivo arm showed EFS, compared to 50% in the control arm.

Additionally, patients treated with Opdivo achieved a 25% pathological complete response rate, significantly higher than the 4.7% observed in the comparator arm.

In July this year, BMS reported a dip in net income of $1.7bn during the second quarter of 2024, a 19% decrease compared to $2.1bn for the same period of last year.