Nivolumab monotherapy induced durable responses with a tolerable safety profile in patients receiving first-line treatment for advanced non-small cell lung cancer (NSCLC), a study published in the Journal of Clinical Oncology has shown.1

The U.S. Food and Drug Administration (FDA) approved nivolumab in October 2015 for the treatment of patients with metastatic NSCLC and progression on or after platinum-based chemotherapy, after a study demonstrated improved survival over docetaxel in previously treated patients with advanced disease. Researchers investigated the activity and safety of nivolumab monotherapy as first-line therapy for advanced NSCLC.

For this phase 1 CheckMate 012 trial, researchers enrolled 52 patients who all received nivolumab 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity. Patients who experienced disease progression were eligible to receive nivolumab beyond progression.

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Seventy-one percent of patients reported adverse events, the most common of which were fatigue (29%), rash (19%), nausea (14%), diarrhea (12%), pruritus (12%), and arthralgia (10%). A total of 19% reported grade 3 to 4 treatment-related adverse events, but grade 3 rash was the only grade 3 to 4 that occurred in more than 1 patient. Twelve percent of patients discontinued immunotherapy due to nivolumab-related adverse events.

Twenty-three percent of patients achieved a confirmed objective response, including 4 ongoing complete responses. Of the 12 responses, 75% occurred by the first tumor assessment during week 11 and 67% were ongoing at the time of data cut-off.

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Among patients with any degree of tumor PD-L1 expression, 28% achieved an objective response; 14% of those with no PD-L1 expression had a response.

Median progression-free survival was 3.6 months and median overall survival was 19.4 months. The 24-week progression-free survival rate and 18-month overall survival rate were 41% (95% CI, 27-54) and 57% (95% CI, 42-70), respectively.


  1. Gettinger S, Rizvi NA, Chow LQ, Borghaei H, Brahmer J, Ready N, et al. Nivolumab monotherapy for first-line treatment of advanced non–small-cell lung cancer [published online ahead of print June 27, 2016]. J Clin Oncol. doi: 10.1200/JCO.2016.66.9929.