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ASCO GI 2023 | Biomarker analysis of nivolumab in patients with advanced refractory biliary tract cancer

Richard Kim, MD, Moffitt Cancer Center, Tampa, FL, discusses immunotherapy (IO) for patients with cholangiocarcinoma. Based on the results of the Phase III TOPAZ-1 (NCT03875235) study of durvalumab with gemcitabine and cisplatin, where an improved in overall-survival (OS) and progression-free survival (PFS) was observed with the addition of durvalumab in patients with advanced biliary tract cancer. Dr Kim talks on a Phase II (NCT02829918) study of nivolumab as a single agent in patients with advanced refractory biliary tract cancer, which demonstrated a response rate of 10%. A biomarker analysis revealed PD-L1 expression on the surface of the tumor, CD8 T-cell infiltration and a high ratio Tregs in the tumor microenvironment (TME) were significantly associated with prolonged PFS, while PD-L1 expression, lymphocytes and CD68 macrophage infiltration in the TME had no predictive value. Following these results and using RNA sequencing data, a 6-gene model was developed for the prediction of patients who benefit from IO. This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Gastrointestinal Cancers (GI) Symposium in San Francisco, CA.

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