Summit Therapeutics

Akeso's Ivonescimab Hits 70.1% Pathological Response in NSCLC Trial

Akeso's Ivonescimab Hits 70.1% Pathological Response in NSCLC Trial

Hong Kong – November 06, 2026 -- Akeso's PD-1/VEGF bispecific antibody ivonescimab combined with chemotherapy produced a 70.1% major pathological response (MPR) rate and a 50.7% pathological complete response (pCR) rate in resectable non-small cell lung cancer (NSCLC), according to Phase II results published in Nature Medicine.

Chemotherapy combination delivers 70.1% MPR and 100% R0 resection

The trial tested perioperative ivonescimab as monotherapy or with chemotherapy. Patients received neoadjuvant treatment, then surgery, then adjuvant ivonescimab. Among patients who underwent surgery in the combination cohort, 68.7% had residual viable tumor of 5% or less.

Akeso's Ivonescimab Wins China Priority Review in Biliary Cancer

HONG KONG – – November 05, 2026 -- China's National Medical Products Administration (NMPA) has granted Priority Review to Akeso's ivonescimab plus chemotherapy for first-line locally advanced or metastatic biliary tract cancer (BTC), a designation expected to accelerate the subsequent regulatory review in China.

HARMONi-GI1 Phase III trial beats durvalumab regimen on overall survival

In the randomized, double-blind, multicenter HARMONi-GI1 study (AK112-309), ivonescimab plus chemotherapy was compared with durvalumab plus chemotherapy, the current global first-line standard in BTC. A prespecified interim analysis reviewed by the Independent Data Monitoring Committee showed the trial met its primary endpoint of overall survival (OS). The improvement over the control arm was statistically significant and clinically meaningful. The study also met all key secondary endpoints, including progression-free survival and objective response rate.