Nivolumab Plus Chemo Approved as Neoadjuvant Therapy for Some Patients With Resectable NSCLC

Based on results of the phase 3 CheckMate-816 trial, the FDA granted approval to the combination of nivolumab plus platinum-doublet chemotherapy for the treatment of non–small cell lung cancer prior to surgery.

Nivolumab (Opdivo) in combination with platinum-doublet chemotherapy is now FDA approved for the treatment of certain patients with resectable non–small cell lung cancer (NSCLC) in the neoadjuvant setting, according to Bristol Myers Squibb.

Patients eligible for the therapy are those with either node positive disease or tumors of 4 cm or greater.

The approval was based on the results of the phase 3 CheckMate 816 study (NCT02998528), which demonstrated a statistically significant improvement in event-free survival (EFS) with nivolumab plus chemotherapy vs chemotherapy alone among patients with early NSCLC.

“Given the rates of disease recurrence in patients with resectable NSCLC, additional treatment options are needed that can be given before surgery to help improve the chance of successful surgical treatment and support the goal of reducing the risk of cancer returning,” Mark Awad, MD, PhD, CheckMate-816 study investigator and clinical director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said in a statement. “The approval of nivolumab with platinum-doublet chemotherapy marks a turning point in how we treat resectable NSCLC and it enables us to use immunotherapy and chemotherapy as neoadjuvant treatment for patients before surgery. Today’s announcement reinforces the need to increase the rates of NSCLC screening and early detection, and for patients to discuss treatment options with their providers.”

Combination therapy with nivolumab/chemotherapy resulted in a 37% reduction in the risk of progression, recurrence, or death vs the active comparator arm (HR, 0.63; 95% CI, 0.45-0.87; P = .0052), with respective medians of 31.6 months and 20.8 months. Pathological complete responses were achieved in 24% of patients treated with nivolumab (95% CI, 18.0%-31.0%) vs 2.2% with chemotherapy alone (95% CI, 0.6%-5.6%; P <.0001). Interim analysis for overall survival showed a hazard ratio of 0.57 (95% CI, 0.38-0.87), which had not crossed the boundary for statistical significance.

EFS data from the trial are planned for presentation at the upcoming 2022 American Association for Cancer Research Annual Meeting 2022 in April.


U.S. Food and Drug Administration approves Opdivo (nivolumab) with chemotherapy as neoadjuvant treatment for certain adult patients with resectable non-small cell lung cancer. News release. Bristol Myers Squibb. March 4, 2022. Accessed March 4, 2022.