AstraZeneca PLC (LSE:AZN) said that Imfinzi, in combination with standard-of-care chemotherapy, was much better than chemotherapy alone in trials on patients with advanced biliary tract cancer (BTC).
The candidate demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit, so an independent monitoring committee confirmed it has met the main goal of the late-stage clinical studies.
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It also achieved its secondary goals of showing an improvement in progression-free survival (PFS) and overall response rate.
The combination was well tolerated and had a similar safety profile to the standard of care with patients stopping the therapy at a normal rate.
BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder.
Around 50,000 people in the US, Europe and Japan and about 210,000 people worldwide are diagnosed every year, often with a poor prognosis as only 5-15% of all patients survive five years.
In December 2020, Imfinzi was granted Orphan Drug Designation in the US for the treatment of BTC.
“We have now delivered two positive gastrointestinal cancer trials in a row for Imfinzi, following the HIMALAYA trial in liver cancer,” said Susan Galbraith, Executive Vice President for Oncology R&D at AstraZeneca.
“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."