Aiwu Ruth He, MD, PhD, discusses next steps for durvalumab in combination with gemcitabine plus cisplatin in patients with advanced biliary tract cancer.
Aiwu Ruth He, MD, PhD, scientific lead, Liver & Biliary Cancers, MedStar Georgetown University Hospital, discusses next steps for durvalumab (Imfinzi) in combination with gemcitabine plus cisplatin in patients with advanced biliary tract cancer.
The phase 3 TOPAZ-1 study (NCT03875235) evaluated first-line durvalumab, an immunotherapy, in combination with the chemotherapy regimen gemcitabine plus cisplatin in this patient population. The addition of durvalumab resulted in an 18-month overall survival (OS) rate of 35.1% compared with 25.6% with placebo plus chemotherapy. This benefit was seen regardless of primary tumor location. Additionally, the combination demonstrated a manageable safety profile, with grade 3 or 4 treatment-related adverse effects occurring in 62.7% of patients who received durvalumab vs 64.9% of patients who received placebo.
TOPAZ-1 is the first phase 3 trial to show that adding immunotherapy to chemotherapy improves OS in this population, He explains. Going forward, further investigation with immune checkpoint inhibitors in cholangiocarcinoma may evaluate dual immunotherapy and immunotherapy plus targeted therapy and chemotherapy, He notes.
The immunotherapy and chemotherapy combination was also well tolerated in TOPAZ-1, as durvalumab did not lead to a significant increase in toxicity, He explains. This regimen could be built upon with additional immunotherapy combinations to improve patient outcomes and quality of life, He concludes.