Akeso has announced a major clinical breakthrough, with its cancer drug ivonescimab meeting the primary endpoint of overall survival in a late-stage biliary tract cancer trial.
The positive result comes from a pre-specified interim analysis of the Phase III study known as HARMONi-GI1, a randomised, controlled, double-blinded, multicentre registrational trial.
The study tested ivonescimab in combination with chemotherapy against AstraZeneca’s Imfinzi, known generically as durvalumab, plus chemotherapy in patients with advanced biliary tract cancer.
The trial met its primary endpoint of overall survival, with Akeso describing the result as both clinically meaningful and statistically significant.
All key secondary endpoints, including progression-free survival and objective response rate, were also met, strengthening the drug’s clinical profile across multiple measures.
The late-stage study was conducted across several centres within a single region of China, under the trial registration number NCT06591520.
Akeso described the outcome as the first positive Phase III result for ivonescimab in gastrointestinal tumours, following four separate positive Phase III readouts in lung cancer.
The company said the result signals that ivonescimab’s clinical value is now expanding from lung cancer into a broader range of solid tumours, a significant development for the programme.
The current standard of care in biliary tract cancer centres on chemotherapy agents gemcitabine and cisplatin combined with an immune checkpoint inhibitor such as Imfinzi or MSD’s Keytruda, also known as pembrolizumab.
Detailed results from the HARMONi-GI1 study are expected to be presented at an upcoming international academic conference and published in a peer-reviewed journal in due course.
The biliary tract cancer win arrives as ivonescimab faces broader scrutiny over differences between Chinese and Western patient data from earlier trials in the programme.
Akeso CEO Michelle Xia has publicly stated that debate surrounding those data differences is overblown, pushing back against concerns that have circulated in the oncology and investment communities.
The US Food and Drug Administration is due to make a decision on ivonescimab’s approval in the American market, with a deadline set for 14 November.