Summit Therapeutics' Ivonescimab Outperforms Durvalumab in Biliary Tract Cancer Study

By Hao Liu • Wednesday, August 26 16:00 • Permanent Link

Summit Therapeutics said its partner Akeso reported that ivonescimab plus chemotherapy beat durvalumab plus chemotherapy in first-line advanced biliary tract cancer in a phase III trial conducted in China.

The study, HARMONI-GI1, met its primary endpoint of overall survival at a pre-specified interim analysis, and also met the key secondary endpoints of progression-free survival and objective response rate. Summit said Akeso described the overall survival result as statistically significant and clinically meaningful.

The readout adds to a growing set of late-stage ivonescimab data. Summit said five phase III studies have now read out, and all five have been positive. Four of those five were in non-small cell lung cancer, and one was in biliary tract cancer.

Among the other phase III results cited, Akeso previously reported positive readouts in HARMONI-A, HARMONI-2 and HARMONI-6 in NSCLC, including statistically significant overall survival benefits in HARMONI-A and HARMONI-6. The company also reported a positive overall survival result in HARMONI-GI1 in advanced biliary tract cancer.

Summit’s own HARMONI study in EGFR-mutated NSCLC produced detailed results in September 2025. The company submitted a biologics license application to the FDA, which accepted it for filing in January 2026, with a PDUFA date set for Nov. 14, 2026.

The company also said it has expanded its ivonescimab program beyond lung cancer. In 2025 it began enrolling patients in HARMONI-7, and in the fourth quarter of 2025 it started HARMONI-GI3 in colorectal cancer. In 2026 it announced HARMONI-GU1 in urothelial carcinoma, with global site activations planned by the fourth quarter of 2026.

Across the broader development program, Summit said there are 16 phase III ivonescimab studies announced, ongoing or completed: five sponsored by Summit, one multiregional study sponsored by a cooperative group, and 10 conducted in China by Akeso.

The press release also said more than 4,000 patients have been treated with ivonescimab in clinical studies globally, and more than 70,000 patients have received it in China in a commercial setting. Following these announcements, the company's shares moved 7.62%, and are now trading at a price of $14.378. For the full picture, make sure to review Summit Therapeutics's 8-K report.

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