Nivolumab Shows Activity in Advanced, Refractory Squamous NSCLC


Key Points

  • Nivolumab produced response in 14.5% of patients, with 77% of responses ongoing at time of analysis.
  • Treatment resulted in stable disease in 26% of patients.

In the phase II CheckMate 063 study reported in The Lancet Oncology, Rizvi et al found that the PD-1 inhibitor nivolumab (Opdivo) produced durable responses in some patients with advanced, refractory squamous non–small cell lung cancer (NSCLC) who had received at least two prior treatments.

Study Details

In the study, 117 patients were enrolled between November 2012 and July 2013 at 27 sites in France, Germany, Italy, and the United States and treated with intravenous nivolumab at 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was objective response rate on independent radiology review.  

Patients had a median age of 65 years; 73% were male; 85% were white; 17% had stage III and 83% stage IV disease; Eastern Cooperative Oncology Group performance status was 0 in 22% and 1 in 78%; and 92% had a history of smoking. The number of previous systemic therapies was two in 35%, three in 44%, and four or more in 21%; all had received prior platinum-based therapy; 74% had received prior radiotherapy; and time from completion of most recent therapy was < 3 months in 76%.

Response Rate

Objective response was observed in 17 patients (14.5%, 95% confidence interval [CI] = 8.7%–22.2%). Median time to response was 3.3 months, and median duration of response was not reached (95% CI = 8.31 months to not estimable). Response was ongoing in 13 (77%) of the 17 responders at the time of analysis. Stable disease was observed in 30 patients (26%), with a median duration 6.0 months (95% CI = 4.7–10.9 months).


Grade 3 or 4 treatment-related adverse events occurred in 20 patients (17%), including fatigue in 4%, pneumonitis in 3%, and diarrhea in 3%. Two treatment-related deaths were observed, due to pneumonia and ischemic stroke in patients with multiple comorbidities and progressive disease.

The investigators concluded: “Nivolumab has clinically meaningful activity and a manageable safety profile in previously treated patients with advanced, refractory, squamous non–small cell lung cancer. These data support the assessment of nivolumab in randomised, controlled, phase 3 studies of first-line and second-line treatment.”

Naiyer A Rizvi, MD, of Columbia University Medical Center, is the corresponding author for The Lancet Oncology article.

The study was funded by Bristol-Myers Squibb. For full disclosures of the study authors, visit

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