Ivonescimab (SMT112/AK112)

HARMONi Phase 3 Clinical Trial

EGFR+ Advanced NSCLC Who Have Progressed After 3rd Generation EGFR-TKI (osimertinib)

NCT05184712: Click to view on ClinicalTrials.gov

Ivonescimab: Most Advanced PD-1/VEGF Bispecific Antibody in Clinical Development in the U.S. & EU.*
Brings two validated mechanisms in oncology^1,2,3 into ONE novel tetravalent molecule.

Ivonescimab simultaneously engages both PD-1 & VEGF.
To-date 825+ patients have been treated with ivonescimab in clinical trials in China and Australia. Summit is actively recruiting 100+ patients in the U.S., Canada and Europe; the overall study will include over 400 patients worldwide.

KEY ELIGIBILITY CRITERIA

• Expected survival ≥3 months
• Locally advanced (Stage IIIB/IIIC) or metastatic NSCLC that has progressed on 3rd generation EGFR-TKI (e.g., osimertinib)
• At least 1 measurable noncerebral lesion
• Adequate organ and hematologic function
• Has not received other systemic antitumor therapy for the advanced stage (IIIB to IV) of NSCLC
• Tumor does not surround important blood vessels, have obvious necrosis and/or cavitation or invade the surrounding vital organs and blood vessels
• No symptomatic metastases of the central nervous system
• No history of esophageal gastric varices, severe ulcers or wounds that do not heal
• No history of severe bleeding tendencies or coagulopathy, or hemoptysis within last 4 weeks

For additional information on the HARMONi Clinical Trial, please contact medinfo@smmttx.com

1. Manegold et al., (2016); JTO 12:2.194-207.; 2. Pardoll, Drew M. (2012) Nature Reviews Cancer vol. 12,4 :252-64.; 3. Tamura et al., (2020) Med Oncol 37:2, 10.1007.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority.

*There are no known PD-1-based bispecific antibodies approved by the U.S. Food and Drug Administration (“FDA”) or the European Medicines Agency (“EMA”).