The Cholangiocarcinoma Foundation Congratulates AstraZeneca TOPAZ-1, the First Phase III Trial

On behalf of patients and families affected by cholangiocarcinoma (cancer of the bile ducts), the Cholangiocarcinoma Foundation congratulates AstraZeneca on its positive results from the Phase III TOPAZ-1 trial. The trial showed that Imfinzi (durvalumab) in combination with standard chemotherapy resulted in improved overall survival (OS) compared to placebo plus chemotherapy in patients with advanced biliary tract cancer (BTC).

“Although single-agent immune checkpoint inhibitors had a modest effect on BTC, the combination of Imfinzi (durvalumab) with standard chemotherapy showed improved survival,” said the research director. and Scientific Director of the Reham Foundation Abdel-Wahab, MD, Ph. RÉ. “These trial results may lead to changes in treatment guidelines in the future. We look forward to the final report of the study to understand treatment efficacy based on bile duct cancer subtypes, patients’ geographic location, underlying disease risk factors, and identification of biomarkers predictive of treatment.

Cholangiocarcinoma is a type of cancer that forms in the bile ducts of the liver. Bile duct cancers are rare and can be very deadly. BTCs include intrahepatic and extrahepatic cholangiocarcinomas and gallbladder cancer, each with different genetics, risk factors, and clinical presentation.

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“Based on the data we see; the TOPAZ trial will offer patients both a chance to improve their survival and quality of life. The results mark a step forward and very likely a significant shift in the trajectory of treatment options available to patients,” said Stacie Lindsey, CEO and Founder of the Foundation. “We look forward to the opportunities this will open up for this community in the future. We are especially grateful to the patients in this trial who have enabled the entire global community to benefit from their participation.

The study’s lead author, Do-Youn Oh, MD, PhD, a professor in the Division of Medical Oncology, Department of Internal Medicine, Seoul National University Hospital and National University of Seoul College of Medicine Seoul in Seoul, South Korea, explained in a press release that patients were recruited into the study from centers in the United States, as well as 17 other countries. More than half of the patients (55%) were recruited from centers located in Asian countries, including South Korea, Thailand, Japan and China. Notably, 55% of patients had intrahepatic cancers, 19% had extrahepatic cancers, and 25% had gallbladder cancer, the statement said.

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According to the press release, the double-blind study randomized 685 patients with locally advanced, recurrent, or metastatic previously untreated, unresectable BTC to receive 1,500 mg of durvalumab every three weeks versus placebo plus 1 000 mg/m2 gemcitabine and 25 mg/m2 cisplatin on days 1 and 8 every three weeks.

Patients were treated for up to eight cycles, followed by durvalumab 1,500 mg every four weeks or placebo until disease progression or unacceptable toxicity, depending on the study. The results demonstrated a 20% reduction in the risk of death with durvalumab plus chemotherapy compared to placebo plus chemotherapy in the patient population studied. In summary, overall survival has improved over time with around one in four patients on Imfinzi plus chemotherapy alive after two years, compared to 1 in 10 on chemotherapy alone.

“I’m so happy to see advances in the standard of care for our patient community that don’t add toxicity but improve overall survival,” said Melinda Bachini, the Foundation’s advocacy director and survivor. “We have had the same standard of care since I was diagnosed with cholangiocarcinoma 12 years ago. It is a long-standing need. I hope this is the start of many advances in this rare cancer.

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With approximately 10,000 cases of cholangiocarcinoma diagnosed each year in the United States, bile duct cancer is the second most common primary liver cancer in the world. It is often diagnosed at advanced stages when treatment is ineffective, highlighting the urgent need for new therapies.

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