ASCO GI 2022 | TOPAZ-1: the addition of durvalumab to chemotherpay for the treatment of BTC in the 1st-line setting

Richard D. Kim, MD, Moffitt Cancer Center, Tampa, FL, highlights the results of the Phase III TOPAZ-1 (NCT03875235) clinical trial that were presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2022. The Phase III trial explored durvalumab in combination with gemcitabine plus cisplatin for advanced biliary tract cancer (BTC) and cholangiocarcinoma in the first-line setting. Patients were randomized to receive either gemcitabine plus cisplatin (gemcis) plus durvalumab or gemcis plus placebo for 6 months followed by maintenance durvalumab or placebo. The primary endpoint was overall survival (OS) and the secondary endpoints included progression-free survival (PFS) and overall-response rate (ORR). The trial met the primary and secondary endpoints and is highly likely to change the current clinical practice for this patients population. However, Dr. Kim points out a possible controversy of the study when observing the Kaplan Myer curve where the median OS begins to separate after 6 months following when half of the patients continue on durvalumab monotherapy and half on placebo, so it could be questioned whether there is an increased benefit arising from durvalumab maintenance therapy versus the combination. Addtionally, Dr. Kim emphasizes that in future, an imporved biomarker that can decipher who will benefit from the treatment combination as opposed to chemotherpay alone would be beneficial. This interview took place at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2022.