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AstraZeneca: Imfinzi Plus Chemotherapy In Phase III Trial Shows Positive Results In BTC Patients

AstraZeneca Plc (AZN.L,AZN) announced Wednesday positive results from the TOPAZ-1 Phase III trial with Imfinzi (durvalumab) in patients with 1st-line advanced biliary tract cancer or BTC.

Imfinzi in combination with standard-of-care chemotherapy, demonstrated a statistically significant and clinically meaningful improvement in overall survival or OS and progression-free survival or PFS versus chemotherapy alone in BTC patients.

TOPAZ-1 is the first Phase III trial to show improved survival with an immunotherapy combination in this setting.

The company noted that Imfinzi plus chemotherapy reduced risk of death by 20% in 1st-line advanced BTC. The combination did not increase discontinuations due to adverse events compared to chemotherapy alone.

AstraZeneca will present these results on January 21 at the 2022 American Society of Clinical Oncology or ASCO Gastrointestinal Cancers Symposium.

BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder. These patients have a poor prognosis, with approximately 5% to 15% of all patients with BTC surviving five years.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, "The results from the TOPAZ-1 trial challenge treatment expectations in advanced biliary tract cancer and provide compelling evidence that longer-term survival is possible. Overall survival improves over time with an estimated one in four patients on Imfinzi plus chemotherapy alive at two years compared to one in ten on chemotherapy alone. This is a potential new standard of care for patients in this setting and we remain committed to making advances in gastrointestinal cancers with high unmet need."

In December 2020, Imfinzi was granted Orphan Drug Designation in the US for the treatment of BTC. In October 2021 , an Independent Data Monitoring Committee recommended the TOPAZ-1 Phase III trial to be unblinded at an interim analysis due to clear evidence of efficacy for Imfinzi plus chemotherapy.

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