What is the role of nivolumab (Opdivo) in the treatment of non–small cell lung cancer (NSCLC)?

Updated: Jul 15, 2021
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
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Nivolumab is a monoclonal antibody inhibitor of PD-1. It is the first immunotherapy approved for NSCLC and may be used in nonsquamous and squamous cell NSCLC. Current NCCN guidelines recommend nivolumab as a treatment option in patients with squamous cell carcinoma that has progressed on first-line therapy. [91]

FDA approval was supported by results from a clinical trial that was stopped early after showing a survival benefit. In the open-label trial, CheckMate 017, 272 patients with advanced or metastatic squamous cell NSCLC were randomly assigned to treatment with either nivolumab 3 mg/kg IV every 2 weeks or docetaxel 75 mg/m² IV every 3 weeks. At 1 year, the overall survival rate was 42% with nivolumab versus 24% with docetaxel. The response rate was 20% with nivolumab versus 9% with docetaxel. The median progression-free survival was 3.5 months with nivolumab versus 2.8 months with docetaxel. [190]

In an early phase I trial of nivolumab in a heavily pretreated group of patients, the response rate was 17%; at a dose of 3 mg/kg, the median overall survival was 14.9 months. Among those patients who responded, the responses were durable, with 24% alive at 24 months. The dose-limiting toxicity was pneumonitis, which resulted in three deaths. [99]

In May 2020, nivolumab combined with ipilimumab was approved for metastatic NSCLC in patients whose tumors express PD-L1 (≥1%), with no EGFR or ALK tumor aberrations. The approval was based on the randomized, open-label trial, Checkmate-227. Patients (n=793) with metastatic or recurrent NSCLC and no prior anticancer therapy were randomized to receive either nivolumab plus ipilimumab or platinum-doublet chemotherapy. The median OS was 17.1 months in the nivolumab plus ipilimumab arm compared with 14.9 months in the platinum chemotherapy arm. [191]

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