1676459974_FDA 1.png

TOPAZ-1 trial

Oncologyme  /  Feb 15, 2023

The FDA has approved #durvalumab (Imfinzi) in combination with gemcitabine and cisplatin in adult patients with locally advanced or metastatic #biliary_tract_cancers.  The approval was based on the phase 2 TOPAZ-1 trial, that randomized 685 patients with unresectable/metastatic biliary tract cancer to first line durvalumab in combination with gemcitabine and cisplatin for up to 8 cycles, followed by durvalumab every 4 weeks or placebo on day 1+ plus the same chemotherapy regimen followed by placebo every 4 weeks. Durvalumab plus chemotherapy significantly improved median overall survival compared to chemotherapy alone, 12.8 months versus 11.5 months, respectively (HR, 0.80; 95% CI, 0.66-0.97; P =.021) in addition to improving PFS (HR, 0.75 - P = .001).