Patients with squamous non-small-cell lung cancer that is refractory to multiple treatments have poor outcomes. Researchers have assessed the activity of Nivolumab ( Opdivo ), a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, for patients with advanced, refractory, squamous non-small-cell lung cancer.
A phase 2, CheckMate 063, single-arm trial at 27 sites ( academic, hospital, and private cancer centres ) in France, Germany, Italy, and USA was done.
Patients who had received two or more previous treatments received intravenous Nivolumab ( 3 mg/kg ) every 2 weeks until progression or unacceptable toxic effects.
The primary endpoint was the proportion of patients with a confirmed objective response as assessed by an independent radiology review committee.
Researchers included all treated patients in the analyses.
During the period 2012-2013, researchers enrolled and treated 117 patients.
17 ( 14.5%, 95% CI 8.7-22.2 ) of 117 patients had an objective response as assessed by an independent radiology review committee.
Median time to response was 3.3 months ( IQR 2.2-4.8 ), and median duration of response was not reached ( 95% CI 8.31-not applicable ); 13 ( 77% ) of 17 of responses were ongoing at the time of analysis.
30 ( 26% ) of 117 patients had stable disease ( median duration 6.0 months, 95% CI 4.7-10.9 ).
20 ( 17% ) of 117 patients reported grade 3-4 treatment-related adverse events, including: fatigue ( five [ 4% ] of 117 patients ), pneumonitis ( four [ 3% ] ), and diarrhoea ( three [ 3% ] ).
There were two treatment-associated deaths caused by pneumonia and ischaemic stroke that occurred in patients with multiple comorbidities in the setting of progressive disease.
In conclusion, 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. ( Xagena )
Rizvi NA et al, Lancet Oncol 2015; Epub ahead of print