TOPAZ-1 trial (2022)
The global Phase III TOPAZ-1 trial tested durvalumab plus chemotherapy against chemotherapy alone in first-line advanced biliary tract cancer. Median overall survival was 12.8 months versus 11.5 months (HR 0.80), a modest but real gain.
Durvalumab plus chemotherapy was adopted as the preferred first-line immunotherapy regimen in both domestic and international guidelines.
It became the benchmark that every new drug in biliary tract cancer would need to beat.
HARMONi-GI1 used the TOPAZ-1 durvalumab-chemo regimen as its control arm and beat it on overall survival—the first Phase III trial to do so in this disease.
