The U.S. Food and Drug Administration (FDA) has expanded approval for nivolumab (Opdivo) to include neoadjuvant treatment combined with platinum-doublet chemotherapy followed by single-agent nivolumab adjuvant treatment of resectable, EGFR and ALK- negative, early-stage non-small cell lung cancer (NSCLC).
Key Points
Treatment Overview
The newly approved regimen consists of two phases:
- Neoadjuvant (before surgery) treatment:
- Nivolumab (Opdivo) combined with platinum-based chemotherapy followed by
- Adjuvant (after surgery) treatment:
- Nivolumab alone
Who Can Benefit
This expanded approval includes treatment for adult patients with:
- Resectable NSCLC (tumors ≥ 4 cm and/or node-positive), and
- No known EGFR mutations or ALK rearrangements
Nivolumab has previously been approved alone or in combination with other therapies as a first treatment option for many cancer types. Nivolumab was the first neoadjuvant therapy approved for NSCLC in 2022 for patients with resectable NSCLC in combination with platinum-doublet chemotherapy based on the results of the CHECKMATE-816 study.
Effectiveness
The expanded approval was based on the CHECKMATE-77T clinical trial, which showed:
- Improved event-free survival compared to chemotherapy alone
- Median event-free survival was not reached in the nivolumab group, versus 18.4 months in the chemotherapy-only group
Safety Considerations
- Side effects were similar to those seen in other nivolumab studies
- A small percentage of patients (5.3%) were unable to undergo surgery due to side effects
What This Means for Patients
Patients with early-stage, resectable NSCLC should discuss this new treatment option with their oncologists to determine if it might be appropriate for their individual cases.
More Reading
Newly Diagnosed With Lung Cancer? What Every Patient Should Know
The Importance of Molecular Testing
Precision Medicines & Immunotherapy
Must Read Tips for Beating Lung Cancer
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References
2. Cascone T, Awad M, Spicer J, et al. Perioperative Nivolumab in Resectable Lung Cancer. N Engl J Med . 2024;390:1756-1769.
