HealthDay News — For patients with advanced, chemotherapy-pretreated, immune checkpoint inhibitor-naive squamous (Sq) non-small cell lung cancer (NSCLC), ipilimumab added to nivolumab does not improve outcomes versus nivolumab alone, according to a study published online July 15 in JAMA Oncology.
Scott N. Gettinger, MD, from the Yale Cancer Center in New Haven, Connecticut, and colleagues enrolled 252 patients with advanced, pretreated, immunotherapy-naive SqNSCLC and a Zubrod score of 0 (asymptomatic) to 1 (symptomatic but completely ambulatory) with disease progression after standard platinum-based chemotherapy in a phase 3, open-label trial. Participants were randomly assigned to either nivolumab/ipilimumab or nivolumab alone (125 and 127, respectively).
At a planned interim analysis, the study was closed for futility. The researchers observed no significant difference between the groups in overall survival (hazard ratio, 0.87; 95% CI, 0.66 to 1.16; P =.34). Median survival was 10 and 11 months in the nivolumab/ipilimumab and nivolumab groups, respectively. The investigator-assessed progression-free survival (IA-PFS) hazard ratio was 0.80 (95% CI, 0.61 to 1.03; P =.09); median IA-PFS was 3.8 and 2.9 months, respectively, for nivolumab/ipilimumab and nivolumab. Grade 3 or higher treatment-related adverse events occurred in 39.5 and 33.3% of those receiving nivolumab/ipilimumab and nivolumab, respectively.
“At present, there is no immunotherapy option for patients who experience disease progression on programmed death 1 axis inhibitor therapy,” the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including Bristol Myers Squibb, the manufacturer of ipilimumab.