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Adding ipilimumab to nivolumab no better in pretreated squamous NSCLC

(HealthDay)—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, M.D., from the Yale Cancer Center in New Haven, Connecticut, and colleagues enrolled 252 patients with advanced, no prescription zofran 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 percent confidence interval, 0.66 to 1.16; P = 0.34). 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 percent confidence interval, 0.61 to 1.03; P = 0.09); 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 percent 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.

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