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Ivonescimab Plus Chemotherapy Demonstrates Overall Survival Superiority Compared to Durvalumab Plus Chemotherapy in First-Line Treatment of Patients with Advanced Biliary Tract Cancer in HARMONi-GI1 Study Conducted by Akeso in China

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First Regimen to Achieve a Statistically Significant and Clinically Meaningful Overall Survival Benefit over an Anti-PD-(L)1 Antibody Combined with Chemotherapy in a Phase III Clinical Trial in BTC

Ivonescimab Plus Chemotherapy Reduced the Risk of Death by 25% Compared to Durvalumab Plus Chemotherapy; OS Hazard Ratio 0.75

Tolerable Safety Profile Consistent with Prior Clinical Trial Results

U.S. Registration-Enabling Phase II / III Study of Ivonescimab in BTC starting in Q4 2026 through Summit's ECOG-ACRIN Collaboration

MIAMI, October 25, 2026--Summit Therapeutics Inc. (Nasdaq: SMMT) today noted that its partner Akeso Inc. announced positive results from the Phase III HARMONi-GI1 study evaluating the novel, potential first-in-class investigational bispecific antibody ivonescimab plus chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced biliary tract cancer (BTC). These data are featured in today's Presidential Symposium II at the European Society for Medical Oncology 2026 Congress (ESMO 2026) in Madrid, Spain.

The HARMONi-GI1 presentation is entitled "Ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer: A randomized, controlled, double-blinded, phase 3 trial (HARMONi-GI1)." The HARMONi-GI1 study is a single-region, multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. The primary endpoint of the HARMONi‑GI1 trial is overall survival (OS) and, as Akeso previously announced, a prespecified analysis showed the ivonescimab-based regimen achieved statistically significant and clinically meaningful superiority in OS compared to the durvalumab-based regimen.

Clinically Meaningful Efficacy

In the HARMONi-GI1 interim analysis of OS, ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement when compared to durvalumab in combination with chemotherapy, with a hazard ratio (HR) of 0.75 (95% CI: 0.61, 0.92; one-sided p=0.0031). A clinically meaningful benefit was demonstrated across clinical subgroups, including age. Median follow-up time of the current data cut was 14.3 months.

HARMONi-GI1 ITT (n=682):

Ivonescimab + Chemo

Durvalumab + Chemo

Median Follow-up: 14.3 mos.

(n=340)

(n=342)

Median OS

14.9 mos.

(95% CI: 12.9, NE)

12.1 mos.

(95% CI: 11.0, 13.4)

OS Stratified HR

0.75

(95% CI: 0.61, 0.92; p = 0.0031 [one-sided])

12-Month OS Rates

59.7%

50.7%

18-Month OS Rates

44.0%

32.5%

ITT = intention-to-treat; n = number; mos.: months; CI=confidence interval; NE: not established

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