Dr Awad on the FDA Approval of Perioperative Nivolumab for Resectable NSCLC

Mark Awad, MD, PhD, chief, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, discusses the significance of the FDA approval of perioperative nivolumab (Opdivo) for patients with resectable non–small cell lung cancer (NSCLC).

On October 3, 2024, the FDA approved nivolumab in combination with platinum-doublet chemotherapy in the neoadjuvant setting, followed by nivolumab monotherapy in the adjuvant setting, for the treatment of adult patients with resectable NSCLC with no known EGFR or ALK rearrangements. This regulatory decision was supported by data from the phase 3 CheckMate 77T trial (NCT04025879), in which the median event-free survival (EFS) in patients who received perioperative nivolumab was not reached (95% CI, 28.9 months-not evaluable) vs 18.4 months (95% CI, 13.6-28.1) in patients who received placebo plus chemotherapy (HR, 0.58; 95% CI, 0.43-0.78; P = .00025).

Recent advancements in NSCLC management have demonstrated significant progress, particularly in early-stage disease, Awad begins. Historically, early-stage NSCLC posed a therapeutic challenge due to high recurrence rates following surgery, he says. For decades, the standard of care (SOC) for this patient population consisted of surgery followed by adjuvant chemotherapy, he notes. However, the introduction of immune checkpoint inhibitors has revolutionized this treatment paradigm, he emphasizes. These agents have initially been shown to be effective in the metastatic setting and are now under evaluation in perioperative settings for earlier-stage disease, Awad explains.

The CheckMate 77T trial, which evaluated the efficacy of perioperative immunotherapy plus chemotherapy, represents a pivotal study in this domain, he adds. This approach builds on those of previous trials that investigated immunotherapy solely in the adjuvant setting, as well as those that examined neoadjuvant immunotherapy alone or in combination with chemotherapy, he notes.

Awad states that CheckMate 77T and similar phase 3 trials, such as KEYNOTE-671 (NCT03425643) and AEGEAN (NCT03800134), demonstrated that the addition of immunotherapy to chemotherapy before surgery, followed by postoperative immunotherapy, significantly reduced recurrence rates in early-stage, resectable lung cancer. Emerging data indicate a clear EFS benefit with this approach, he says. These findings support the use of immunotherapy regimens to enhance SOC treatment for patients with early-stage lung cancer, potentially increasing cure rates and prolonging survival, he emphasizes. As ongoing trials yield long-term follow-up data, the role of immunotherapy in early-stage lung cancer is expected to solidify, paving the way for broader clinical application and improved patient prognosis, he concludes.