Adding sintilimab, an anti-PD-1 antibody, to first-line platinum-based chemotherapy enhances efficacy in patients with locally advanced or metastatic nonsquamous NSCLC. In the randomized, placebo-controlled, phase III ORIENT-11 trial conducted in China, median progression-free survival (PFS) reached 5.0 months with chemotherapy but improved to 8.9 months when sintilimab was paired with chemotherapy (hazard ratio [HR] 0.482, 95% CI 0.362-0.643]; P < 0.00001), thus meeting the primary endpoint of the trial. In addition, the chemoimmunotherapy combination produced clear-cut improvements in median PFS across nearly all patient subgroups.
According to lead investigator Li Zhang, MD, of the Sun Yat-Sen University Cancer Centre, treatment options are limited for patients with nonsquamous NSCLC lacking sensitive EGFR mutations or ALK rearrangements. “Treatment with an anti-PD-1 monoclonal antibody in combination with chemotherapy may bring a greater survival benefit to this patient population. We are glad to see that these findings from this trial of sintilimab met the predefined primary endpoint in the interim analysis."
