Multicenter phase 3 trial of first-line toripalimab plus nab-paclitaxel for recurrent or metastatic triple-negative breast cancer

The combination of immune checkpoint blockade with chemotherapy for the first-line treatment of advanced triple-negative breast cancer (TNBC) has generated mixed results. The multicenter phase 3 TORCHLIGHT trial in China randomized 300 patients with PD-L1 positive recurrent or metastatic (R/M) TNBC 2:1 to first-line toripalimab plus nab-paclitaxel (experimental arm; n=200) or placebo plus nab-paclitaxel (n=100). Primary end point was progression-free survival by blinded central review. At the prespecified interim analysis, the median progression-free survival was 8.4 months in the experimental arm versus 5.6 months in the control arm (HR 0.65; p=0.0102. The median overall survival was 32.8 versus 19.5 months (HR 0.62; p=0.0148). Similar incidences of treatment-emergent adverse events were seen in the experimental and control arms (any grade 99.2% versus 98,8%; grade 3 or higher 56.4% versus 54.3%; fatal 0.6% versus 3.4%). The authors conclude that among women with PD-L1 positive R/M TNBC, addition of toripalimab to first-line nab-paclitaxel was associated with improvement of PFS and OS, without increased toxicity.