Treatment combinations including durvalumab (Imfinzi®) show benefit in patients with cholangiocarcinoma (CCA) and other liver cancers, according to data from the phase 3 HIMALAYA and TOPAZ-1 trials recently presented at scientific meetings.

“TOPAZ-1 data show that Imfinzi plus chemotherapy improved outcomes for biliary tract cancer patients regardless of where their tumor was located or where they lived,” said Cristian Massacesi, chief medical officer and oncology chief development officer of AstraZeneca, the developer of the therapy.

“These important subgroup analyses add to the body of evidence demonstrating the potential for Imfinzi combinations to meaningfully improve outcomes for these patients who are in need of effective and generally well tolerated treatments.”

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The phase 3 TOPAZ-1 trial, conducted in 17 countries, assessed the efficacy and safety of durvalumab in combination with gemcitabine plus cisplatin chemotherapy versus chemotherapy plus placebo in 685 patients with intrahepatic and extrahepatic CCA and gallbladder cancer. The primary endpoint was overall survival.

The results showed a significant and clinically meaningful benefit in overall survival for all patients with durvalumab compared with placebo, according to a press release from AstraZeneca. The benefit was consistent and occurred regardless of patient location (North America, Europe, or Asia), and adverse events were similar among the treatment groups.  

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Durvalumab is a human monoclonal antibody approved for use as immunotherapy in several cancers. It blocks the interaction of PD-L1 protein and PD-1 and CD80 proteins by binding with the PD-L1 protein, helping counter the tumor’s ability to evade the immune system and restoring the natural immune response.

AstraZeneca presented the results at the European Association for the Study of the Liver’s International Liver Congress 2022 and the European Society for Medical Oncology’s World Congress on Gastrointestinal Cancer.


AstraZeneca shares data at EASL and ESMO World GI for IMFINZI® (durvalumab) combinations in patients with liver and biliary tract cancers. News Release. AstraZeneca; July 1, 2022.