What will the sonesitatug vedotin-ivonescimab collaboration study?
AstraZeneca and Summit also signed a clinical collaboration agreement to evaluate sonesitatug vedotin (Sone-Ve), an investigational claudin-18.2 (CLDN18.2)-targeted ADC carrying a monomethyl auristatin E payload, in combination with ivonescimab. The companies intend to initiate trials in gastrointestinal cancers under the agreement imminently, contributing their own medicines and sharing trial costs while retaining commercial rights to each.¹
The companies also signed a memorandum of understanding outlining intent to launch a broader global development program pairing ivonescimab with additional AstraZeneca cancer medicines, including other ADCs. Maky Zanganeh, DDS, Summit's president and co-CEO, said in the release that the agreements broaden ivonescimab's development plan and open trials combining it with novel anti-cancer compounds, including ADCs.¹
What clinical evidence supports pairing the 2 drugs?
AstraZeneca has reported that sonesitatug vedotin met its primary endpoint in the phase 3 CLARITY-Gastric01 trial, showing a statistically significant and clinically meaningful overall survival improvement among patients with 2nd- and later-line claudin18.2-positive advanced gastric or gastroesophageal junction cancer, versus investigator's choice of therapy. Full results are expected at the European Society for Medical Oncology Congress 2026.¹ A fuller company update on that trial specified dual primary endpoints were met, though progression-free survival by independent central review did not reach statistical significance.²
Ivonescimab, engineered by Akeso and licensed to Summit outside China, is approved in China for certain non-small cell lung cancer (NSCLC) patients. Its activity already has peer-reviewed backing. In the phase 3 HARMONi-2 trial published in The Lancet, ivonescimab nearly doubled median progression-free survival versus pembrolizumab (11.1 vs 5.8 months; hazard ratio, 0.51) in 398 patients with programmed cell death ligand 1-positive NSCLC.³
Ivonescimab is separately under FDA review for epidermal growth factor receptor-mutated NSCLC. The agency accepted Summit's biologics license application (BLA) for that indication in January 2026, with a Prescription Drug User Fee Act goal date of November 14, 2026, based on the phase 3 HARMONi trial.⁴ The biologic is also in phase 3 trials for small cell lung cancer, biliary tract cancer, bladder cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, colorectal cancer, and pancreatic cancer.¹
What are the limitations?
The memorandum of understanding for a broader ivonescimab–ADC program reflects intent rather than a signed agreement, and its terms could change before a final deal is reached. FDA’s acceptance of Summit's BLA for ivonescimab in NSCLC does not necessarily guarantee approval, and the November 14, 2026, goal date could be extended. The CLARITY-Gastric01 results remain topline data that have not been peer-reviewed or presented in full.² The gastrointestinal-cancer trials combining sonesitatug vedotin and ivonescimab have not yet begun.
References
- AstraZeneca. AstraZeneca announces strategic equity investment and clinical collaboration with Summit Therapeutics to advance leading ADC combination strategy in cancer. Press release. Published September 28, 2026. Accessed September 29, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/astrazeneca-announces-equity-investment-summit.html
- AstraZeneca. Sonesitatug vedotin demonstrated a statistically significant and highly clinically meaningful improvement in overall survival in 2nd and later-line CLDN18.2-positive advanced gastric/GEJ cancers. Press release. Published July 27, 2026. Accessed September 29, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/sone-ve-improved-survival-in-gastric-cancers.html
- Xiong A, Wang L, Chen J, et al. Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomized, double-blind, phase 3 study in China. Lancet. 2025;405(10481):839-849. doi:10.1016/S0140-6736(24)02722-3
- Summit Therapeutics. Summit Therapeutics announces US FDA acceptance of biologics license application (BLA) seeking approval for ivonescimab in combination with chemotherapy in treatment of patients with EGFRm NSCLC post-TKI therapy. Press release. Published January 29, 2026. Accessed September 29, 2026. https://smmttx.com/news/press-releases/news-details/2026/Summit-Therapeutics-Announces-U-S--FDA-Acceptance-of-Biologics-License-Application-BLA-Seeking-Approval-for-Ivonescimab-in-Combination-with-Chemotherapy-in-Treatment-of-Patients-with-EGFRm-NSCLC-Post-TKI-Therapy/default.aspx