Summit Therapeutics Surpasses AstraZeneca with Cancer Drug

Achieving 14.9 months of median overall survival, Summit Therapeutics (SMMT) exceeded the current standard of care in biliary tract cancer. Results of the Phase 3 HARMONi-GI1 study conducted by the company's Chinese partner Akeso (9926.HK) were announced at the ESMO 2026 congress in Madrid. Administered in combination with chemotherapy, the bispecific antibody ivonescimab surpassed AstraZeneca's (AZN) Imfinzi (durvalumab) regimen, which offered a median survival of 12.1 months; it reduced the risk of death in the treatment regimen by 25%.

What results were obtained in the HARMONi-GI1 trial?

In the clinical trial, which enrolled a total of 682 patients and had a median follow-up of 14.3 months, ivonescimab demonstrated a clear advantage in delaying disease progression. While the median time without cancer progression reached 8.4 months in patients receiving the drug, this period remained at 5.8 months in the durvalumab group. On the ivonescimab side, the risk of disease progression or death decreased by 39%. The tumor shrinkage rate was determined as 53.8% in the ivonescimab group and 32.5% in the comparator group. At month 18, the survival rate stood at 44% and 32.5%, respectively.

When will ivonescimab enter the US approval process?

In the ivonescimab group, which simultaneously blocks PD-1 and VEGF targets, the incidence of serious adverse events stood at 43.4%, compared to 43.7% in the durvalumab group; no new safety concerns were recorded. Approved in China for non-small cell lung cancer, the molecule is in the investigational stage in the US and European markets. Summit, which holds the licensing rights, is preparing to activate sites for Phase II/III trials in the US in the 4th quarter of 2026. In this study, the company aims to lay the groundwork for the FDA approval process by comparing the drug with durvalumab and Keytruda, produced by Merck (MRK).

This content is for information purposes only and does not constitute investment advice.