ABSTRACT In the Phase III TASUKI‐52 trial, nivolumab with carboplatin, paclitaxel (CP), plus bevacizumab significantly prolonged progression‐free survival (PFS), and resulted in longer overall survival (OS) in patients with advanced nonsquamous non‐small cell lung cancer (NSCLC). This final analysis evaluated 4‐year treatment outcomes in terms of OS, PFS and duration of response (DOR) by investigator assessment and safety, as well as the background characteristics and treatment courses associated with 4‐year survivors. Patients were randomized 1:1 to receive nivolumab ( n = 275) or placebo ( n = 275) in addition to CP plus bevacizumab. With a minimum follow‐up of 53.1 months, nivolumab with CP plus bevacizumab continued to show improvement in OS (hazard ratio HR, 0.71; 95% confidence interval CI, 0.58–0.88) and PFS (HR: 0.61; 95% CI: 0.50–0.74) compared to placebo with CP plus bevacizumab. The 4‐year OS rate was 34.7% in the nivolumab arm versus 22.1% in the placebo arm, and the 4‐year PFS rate was 13.7% in the nivolumab arm versus 3.3% in the placebo arm. Among 4‐year survivors, the median DOR was numerically longer in the nivolumab arm than in the placebo arm (34.7 vs. 13.5 months). No new safety signals were observed. Four‐year survival in the nivolumab arm was associated with the absence of bone metastases and age < 65, but not with PD‐L1 status and tumor size. In conclusion, treatment with nivolumab demonstrated long‐term survival benefit and durable response, which supports nivolumab with CP plus bevacizumab as a first‐line treatment option for advanced nonsquamous NSCLC. Trial Registration: ClinicalTrials.gov identifier: NCT03117049
Lee et al. (Thu,) studied this question.