Durvalumab, Chemotherapy Improves Overall Survival, Progression-Free Survival for Patients With Biliary Tract Cancer


Durvalumab (Imfinzi, AstraZeneca), combined with standard-of-care chemotherapy, demonstrated a clinically meaningful benefit in patients with advanced biliary tract cancer.

Durvalumab (Imfinzi, AstraZeneca), combined with standard-of-care chemotherapy, demonstrated a clinically meaningful benefit to overall survival (OS) compared with chemotherapy alone as a first-line treatment for patients with advanced biliary tract cancer (BTC), according to the high-level results from the TOPAZ-1 phase 3 trial. The investigators said this is the first immunotherapy combination to demonstrate superior clinical outcomes over standard of care in a global, randomized trial in this setting.

“Patients with advanced biliary tract cancer are in dire need of new treatments as progress in the first-line setting has remained largely stagnant for more than 10 years,” said Do-Youn Oh, MD, PhD, professor in the Division of Medical Oncology in the Department of Internal Medicine at Seoul National University Hospital and Seoul National University College of Medicine, in a press release. “TOPAZ-1 is the first phase 3 trial to show that adding an immunotherapy to standard chemotherapy delivers a meaningful overall survival benefit for patients in this setting.”

In addition to meeting the primary endpoint of OS improvement, the drug combination also demonstrated improvements to progression-free survival and overall response rate. Durvalumab plus chemotherapy was generally well-tolerated, with a similar safety profile to the comparator arm, and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone

“We are delighted TOPAZ-1 has been unblinded early due to clear evidence of efficacy for Imfinzi plus chemotherapy, which has also demonstrated a strong safety profile,” said Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, in the release. “We have now delivered 2 positive gastrointestinal cancer trials in a row for Imfinzi, following the HIMALAYA trial in liver cancer. We believe the significant survival benefit demonstrated marks a new era of immunotherapy treatment in this devastating disease, and it advances our commitment to improving long-term survival for patients across these cancers where treatment options are limited.”

BTC is a group of rare and aggressive cancers, occurring in the bile ducts and gallbladder, which is diagnosed in 210,000 individuals globally each year. Early-stage BTC often presents without symptoms, resulting in most diagnoses occurring at late stages when treatment options are limited and prognoses are poor. Durvalumab was granted orphan drug designation by the FDA in December 2020 for the treatment of BTC.


Imfinzi plus chemotherapy significantly improved overall survival in 1st-line advanced biliary tract cancer in TOPAZ-1 Phase III trial at interim analysis [news release]. AstraZeneca; October 25, 2021. Accessed October 25, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/imfinzi-improved-survival-in-biliary-tract-cancer.html

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