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(Alliance News) - AstraZeneca PLC on Monday reported that its trial of cancer drug Imfinzi demonstrated a "statistically significant and clinically meaningful overall survival benefit" compared to chemotherapy treatment alone.
The positive results from the Topaz-1 Phase III trial showed that Imfinzi, when used in combination with standard-of-care chemotherapy, was effective as a treatment for patients with advanced biliary tract cancer.
The trial met the primary endpoint by demonstrating an improvement in overall survival and also an improvement in progression-free survival and overall response rate, key secondary endpoints, Astra highlighted.
Astra said the combination of Imfinzi and chemotherapy was well tolerated and had a "similar safety profile" 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 Research & Development 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."
The test results are the second positive gastrointestinal cancer trial findings in a row for Imfinzi, following the Himalaya Phase 3 which showed Imfinzi monotherapy improved overall survival in first-line unresectable liver cancer.
Biliary tract cancer is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder, with around 210,000 people worldwide diagnosed each year.
Shares in AstraZeneca were trading up 0.2% at 9,018.00 pence each in London on Monday morning. The wider FTSE 100 index was up 0.3%.
By Will Paige; willpaige@alliancenews.com
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