Chinese biotech firm Akeso Inc has announced positive interim results from a registrational Phase-3 trial, showing that its home-grown bispecific antibody ivonescimab combined with chemotherapy delivers statistically significant and clinically meaningful overall-survival benefits for patients with advanced biliary-tract cancer, compared with durvalumab plus chemotherapy.
Durvalumab plus chemotherapy is currently the globally-recognized standard-of-care first-line immunotherapy recommended by major international clinical guidelines for advanced BTC, an aggressive malignancy with limited treatment options and poor patient prognosis.Conducted in a randomised, double-blind, multicentre setting, the study hit its pre-specified primary endpoint of overall-survival, as reviewed by an Independent Data Monitoring Committee.All key secondary endpoints, including progression-free survival and objective response rate, were also achieved. Full detailed clinical data will be unveiled at upcoming international medical conferences and later published in peer-reviewed journals, the company said in a statement.
That means the trial, named as HARMONi-GI1, marks the first Phase-3 trial worldwide to yield a statistically superior OS outcome against this gold-standard PD-L1-based regimen for biliary-tract cancer, representing a landmark advance for this hard-to-treat tumour type.
