Phase 3 study of first-line nivolumab or placebo with carboplatin-paclitaxel-bevacizumab for advanced nsqNSCLC

The phase 3 TASUKI-52 study in Japan, Taiwan, and South Korea randomized patients with previously untreated stage IIIB/IV non-squamous NSCLC without sensitizing EGFR, ALK, or ROS1 alterations to up to six cycles of nivolumab-carboplatin-paclitaxel- bevacizumab or placebo-carboplatin-paclitaxel-bevacizumab, followed by nivolumab-bevacizumab or placebo-bevacizumab until progression or unacceptable toxicity. Interim analysis after median follow-up of 13.7 months found median PFS 12.1 months in de nivolumab arm versus 8.1 months in de placebo arm (HR 0.56; p<0.0001). The incidence of grade 3 and 4 treatment-related adverse events was comparable between arms. Grade 5 TRAEs were reported for five patients in the nivolumab arm and four patients in the placebo arm. The authors conclude that the TASUKI-52 regimen with nivolumab should be considered a viable new first-line treatment strategy for advanced nsqNSCLC.