First-Line Nivolumab Active in Combination With Platinum-Based Doublets in Advanced NSCLC


Key Points

  • Nivolumab was active in combination with platinum-based doublets as first-line treatment in patients with advanced NSCLC.
  • All study treatment was discontinued in 21% of patients.

Nivolumab (Opdivo) was found to be active combined with platinum-based doublets as first-line treatment of advanced non–small cell lung cancer (NSCLC), as part of the phase I CheckMate 012 study reported by Rizvi et al in the Journal of Clinical Oncology. The study is also evaluating nivolumab monotherapy in this setting.

Study Details

A total of 56 patients with stage IIIB or IV disease received nivolumab plus a platinum-based doublet every 3 weeks for 4 cycles followed by nivolumab alone until disease progression or unacceptable toxicity. Treatments consisted of nivolumab at 10 mg/kg plus gemcitabine/cisplatin (n = 12; for squamous histology) or pemetrexed (Alimta)/cisplatin (n = 15; nonsquamous histology) or nivolumab at 5 (n = 14) or 10 mg/kg (n = 15) plus paclitaxel/carboplatin (all histologies).


No dose-limiting toxicities were observed during the first 6 weeks of treatment. Grade 3 or 4 treatment-related adverse events occurred in 45% of patients, with the most common being pneumonitis (7%) and acute renal failure (5%). Treatment-related adverse events led to discontinuation of all study therapy in 21% of patients.


Objective response rates were 33%, 47%, 47%, and 43% with nivolumab at 10 mg/kg plus gemcitabine/cisplatin, nivolumab at 10 mg/kg plus pemetrexed/cisplatin, nivolumab at 10 mg/kg plus paclitaxel/carboplatin, and nivolumab at 5 mg/kg plus paclitaxel/carboplatin, respectively. Median durations of response were 10.3, 5.8, 5.5, and 19.6 months. Progression-free survival at 24 weeks was 51%, 71%, 38%, and 51%. Two-year overall survival was 25%, 33%, 27%, and 62%. Responses were observed irrespective of tumor PD-L1 (programmed cell death ligand 1) expression status.

The investigators concluded: “The safety profile of nivolumab plus [platinum-base doublet chemotherapy] was consistent with that expected for individual agents; however, treatment discontinuation related to [adverse events] was greater with the combination. Encouraging activity was observed, especially for the nivolumab 5 mg/kg plus paclitaxel-carboplatin group, with a 2-year [overall survival] rate of 62%.”

The study was supported by Bristol-Myers Squibb.

Naiyer A. Rizvi, MD, of Columbia University Medical Center, is the corresponding author of the Journal of Clinical Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.