Results from the TOPAZ-1 phase 3 clinical trial suggest that durvalumab (Imfinzi®) combined with chemotherapy could increase overall survival in patients with biliary tract malignancies, including cholangiocarcinoma (CCA), according to a recently published press release.

The trial results indicated that the combination of durvalumab and gemcitabine plus cisplatin can increase overall survival in patients with biliary tract cancer by approximately 24% compared to patients who receive chemotherapy alone. Two years after treatment initiation, 23% of patients receiving durvalumab were alive compared to 11% of patients in the control group.

“With limited treatment advances over the past decade, these patients have long faced a dismal prognosis,” said Do-Youn Oh, MD, PhD, the trial’s principal investigator. “For the first time, an immunotherapy-based combination has shown the ability to alter the course of treatment for this disease and should become the new standard of care.”

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Durvalumab is a monoclonal antibody that blocks the interaction between PD-L1 and the PD-1 and CD80 proteins, thus impeding immune evasion by the tumor and favoring the development of appropriate immune responses. The drug has been successfully used in chemotherapy-resistant non-small cell lung cancer and in patients with advanced bladder cancer.

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The TOPAZ-1 clinical trial includes approximately 700 patients with biliary tract cancer, including intrahepatic and extrahepatic CCA and gallbladder cancer.

There was no significant difference in the incidence of adverse effects between patients receiving durvalumab plus chemotherapy and those receiving chemotherapy alone. Approximately 60% of patients in the study presented with grade 3 or 4 adverse effects. The durvalumab plus chemotherapy group did not appear to have a significant increase in treatment discontinuation due to adverse effects. Treatment discontinuation reached approximately 6% in both groups.

Common immune-mediated adverse effects include pneumonitis with an incidence of approximately 2%, colitis with an incidence of approximately 2%, hepatitis with an incidence below 1%, and immune-mediated rash and dermatitis with an incidence of approximately 2%.


IMFINZI® (durvalumab) plus chemotherapy further improved overall survival benefit in advanced biliary tract cancer in the TOPAZ-1 phase III trial, reducing the risk of death by 24% in additional follow-up. News release. AstraZeneca. September 12, 2022.