AstraZeneca has announced positive high-level data from a Phase III trial, which showed that the combination of Imfinzi (durvalumab) and chemotherapy significantly improved overall survival (OS) as a first-line therapy for advanced biliary tract cancer (BTC) patients.

The randomised, double-blind, placebo-controlled, multicentre, global TOPAZ-1 trial enrolled 685 subjects with unresectable advanced or metastatic BTC, including intrahepatic and extrahepatic cholangiocarcinoma; and gallbladder cancer, excluding ampullary carcinoma.

It is being conducted in more than 145 sites in 17 countries such as the US, South America and Europe, as well as many Asian countries, including Japan, China, Thailand, Taiwan and South Korea.

The Independent Data Monitoring Committee has concluded that the trial met the primary endpoint of OS, at a predefined interim analysis.

An improvement in patients’ OC was found when treated with Imfinzi plus chemotherapy combination compared to the treatment with chemotherapy alone.

The combination therapy also met the key secondary endpoints that include improvement in patients’ progression-free survival (PFS), as well as overall response rate.

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AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “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.

“We have now delivered two 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.”

A human monoclonal antibody, Imfinzi attaches to and hinders the interaction of PD-L1 with PD-1 and CD80 proteins. It received Orphan Drug Designation in the US to treat BTC, in December last year.