FIRST LINE NIVOLUMAB FOR NSCLC

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.

Toxicity

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).

Responses

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 Oncologyarticle.