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

Based on the results of the Phase 3 CheckMate-816 trial, the FDA cleared the combination of nivolumab and dual platinum-based chemotherapy for the treatment of non-small cell lung cancer before surgery.

According to Bristol Myers Squibb, nivolumab (Opdivo) in combination with dual platinum-based chemotherapy is now FDA-approved for the treatment of certain patients with resectable non-small cell lung cancer (NSCLC) in the setting of neoadjuvant therapy.

Patients eligible for therapy are those with either node-positive disease or tumors 4 cm or larger.

The approval was based on results from the CheckMate 816 study (NCT02998528), which demonstrated a statistically significant improvement in event-free survival (EFS) with nivolumab plus chemotherapy compared to chemotherapy alone in patients with Early NSCLC.

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

Combination treatment with nivolumab/chemotherapy resulted in a 37% reduction in the risk of progression, recurrence or death compared to the active comparator arm (HR, 0.63; 95% CI, 0.45-0.87; P = 0.0052), 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% to 31.0%) versus 2.2% with chemotherapy alone (95% CI, 0.6% at 5.6%; P <.0001 the interim analysis of overall survival showed a hazard ratio ci which did not cross limit statistical significance.>

EFS data from the trial is expected to be presented at the upcoming American Association for Cancer Research 2022 Annual Meeting in April.


The United States Food and Drug Administration approves Opdivo (nivolumab) with chemotherapy as neoadjuvant therapy for certain adult patients with resectable non-small cell lung cancer. Press release. Bristol Myers Squibb. March 4, 2022. Accessed March 4, 2022.

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