Nivolumab monotherapy produced durable responses and encouraging survival rates in patients with heavily pretreated non-small cell lung cancer (NSCLC), a new study published online early in the Journal of Clinical Oncology has shown.

For the study, researchers enrolled 129 patients with heavily pretreated advanced NSCLC. Participants received nivolumab 1, 3, or 10mg/kg intravenously once every 2 weeks in 8-week cycles. Patients were treated for up to 96 weeks.

Results showed a median overall survival of 9.9 months. The 1-, 2-, and 3-year overall survival rates were 42%, 24%, and 18%, respectively, across all three doses. The 1-, 2-, and 3-year overall survival rates were 56%, 42%, and 27%, respectively for the 3mg/kg dose.

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Researchers found that 17% of patients achieved objective responses with an estimated median duration of response of 17.0 months.

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Of note, response rates were observed to be similar in patients with squamous and nonsquamous NSCLC.

In regard to safety, 14% off patients experienced grade 3-4 nivolumab-related adverse events, and 2% of patients died due to nivolumab-associated pneumonitis.

Earlier this year, the U.S. Food and Drug Administration (FDA) approved nivolumab 3mg/kg intravenously every 2 weeks for the treatment of patients with metastatic squamous NSCLC who progressed on or after platinum-based chemotherapy.


  1. Gettinger SN, Horn L, Gandhi L, et al. Overall survival and long-term safety of nivolumab (anti-programmed death 1 antibody, BMS-936558, ONO-4538) in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2015. [Epub ahead of print]. doi: 10.1200/JCO.2014.58.3708.