Multicenter randomized phase 2 trial of addition of nivolumab to first-line carboplatin for metastatic triple-negative breast cancer

A multicenter randomized phase 2 trial in the USA evaluated addition of nivolumab to first-line carboplatin for metastatic triple-negative breast cancer (mTNBC). Among 62 patients, the median progression-free survival (PFS) was 4.2 months with carboplatin plus nivolumab versus 5.5 months with carboplatin alone, whereas the median overall survival (OS) also did not differ significantly between arms (16.8 months versus 11.1 months). Among the 24 PD-L1-positive mTNBC patients, median PFS was 8,3 versus 4.7 months and median OS was 17.6 versus 10.7 months. Grade ≥ 3 adverse events occurred in 56.8% of patients in the combination arm and 65.8% in the carboplatin arm. The authors conclude that addition of nivolumab to first-line carboplatin did not improve survival among all mTNBC patients, but did improve survival among patients with PD-L1-positive disease.