First-line Nivolumab Monotherapy Induces Durable Responses in Advanced NSCLC

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.

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.

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.

Reference

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.