Akeso, Inc. announced that ivonescimab in combination with chemotherapy for the first-line treatment of locally advanced or metastatic biliary tract cancer (BTC) has been granted Priority Review by China's National Medical Products Administration (NMPA). The Priority Review designation is expected to accelerate the subsequent regulatory review process for this indication in China.

In the randomized, double-blind, multicenter Phase III registrational study HARMONi-GI1 (AK112-309), ivonescimab plus chemotherapy demonstrated superior survival benefit for patients versus durvalumab plus chemotherapy, the current global standard for the first-line treatment of BTC. In a prespecified interim analysis reviewed by the Independent Data Monitoring Committee (IDMC), HARMONi-GI1 met its primary endpoint of overall survival (OS), with the ivonescimab plus chemotherapy arm demonstrating statistically significant and clinically meaningful improvement over the control arm. The trial also met all key secondary endpoints, including progression-free survival (PFS) and objective response rate (ORR).

The HARMONi-GI1 results were presented as a Late-Breaking Abstract in an oral presentation at the ESMO Presidential Symposium in October 2026. HARMONi-GI1 is the first Phase III trial in BTC to show statistically significant overall survival benefit against the established PD-L1 inhibitor plus chemotherapy standard of care.

On October 21, 2026, Summit announced a clinical trial collaboration with ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) to evaluate the safety and efficacy of ivonescimab with chemotherapy compared to pembrolizumab or durvalumab plus chemotherapy in a registration-enabling Phase II/III study (EA2251), in the first-line treatment of patients with advanced BTC.

 

Source: prnewswire.com

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