First-Line Nivolumab Monotherapy Active in Advanced NSCLC


Key Points

  • First-line nivolumab had an acceptable safety profile in patients with advanced NSCLC.
  • Treatment was associated with durable responses, including complete responses.

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

A total of 52 patients with stage IIIB to IV disease were treated with nivolumab at 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity. Treatment after disease progression was permitted.


Treatment-related adverse events of any grade occurred in 71% of patients, with the most common being fatigue (29%), rash (19%), nausea (14%), diarrhea (12%), pruritus (12%), and arthralgia (10%). Grade 3 or 4 treatment-related adverse events occurred in 19% of patients, with grade 3 rash being the most common (2 patients, 4%).

Study treatment was discontinued due to an adverse event in 6 patients (12%), including grade 4 increased alanine transaminase and grade 3 increased aspartate transaminase (in 1 patient) and cardiac failure, hyperglycemia, increased lipase, diarrhea, and pneumonitis (all grade 3, 1 patient each).


Confirmed objective response occurred in 12 of 52 patients (23%), including an ongoing complete response in 4. Response occurred by first tumor assessment at 11 weeks in 9 of 12 responders (75%). At the time of analysis, 8 responses were ongoing at 5.3+ to 25.8+ months. Response was observed in 9 of 32 patients (28%) with any degree of tumor PD-L1 (programmed cell death protein 1) expression and in 2 of 14 patients (14%) with no PD-L1 expression.

Median progression-free survival was 3.6 months, and progression-free survival at 24 weeks was 41%. Median overall survival was 19.4 months, with 1-year and 18-month rates of 73% and 57%, respectively.

The investigators concluded: “First-line nivolumab monotherapy demonstrated a tolerable safety profile and durable responses in first-line advanced NSCLC.”

The study was supported by Bristol-Myers Squibb.

Scott Gettinger, MD, of Yale Cancer 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®.