First-line nivolumab in conjunction with a platinum-based doublet chemotherapy regimen demonstrated encouraging activity, but with increased toxicity-related treatment discontinuation, in patients with advanced non-small cell lung cancer (NSCLC), a study published in the Journal of Clinical Oncology has shown.1

Nivolumab, a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, improves survival in previously treated patients with advanced NSCLC. Researchers assessed the safety and efficacy of nivolumab as monotherapy or with current standard therapies in the first-line treatment setting.

For this phase 1 CheckMate 012 trial, investigators assigned 56 patients to receive nivolumab 10 mg/kg intravenously plus platinum-based doublet chemotherapy concurrently every 3 weeks for 4 cycles, followed by nivolumab alone until disease progression or unacceptable toxicity. Possible drug combinations were nivolumab 10 mg/kg plus gemcitabine-cisplatin (squamous histologies) or pemetrexed-cisplatin (nonsquamous histologies) or nivolumab 5 or 10 mg/kg plus paclitaxel-carboplatin (all histologies).

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Investigators observed no dose-limiting toxicities during the first 6 weeks of treatment, though 21% of patients discontinued study therapy due to treatment-related adverse events. Grade 3 or 4 treatment-related adverse events were reported by 45% of patients; 7% experienced pneumonitis.

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Twenty-four-week progression-free survival rates for nivolumab 10 mg/kg plus gemcitabine-cisplatin, nivolumab 10 mg/kg plus pemetrexed-cisplatin, nivolumab 10 mg/kg plus paclitaxel-carboplatin, and nivolumab 5 mg/kg plus paclitaxel-carboplatin were 51%, 71%, 38%, and 51%, and 2-year overall survival rates were 25%, 33%, 27%, and 62%, respectively.

The study demonstrated responses regardless of tumor PD-L1 expression status.                            


  1. Rizvi NA, Hellmann MD, Brahmer JR, Juergens RA, Borghaei H, Gettinger S, et al. Nivolumab in combination with platinum‐based doublet chemotherapy 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.2016.66.9861.