Ivonescimab (SMT112 / AK112)

HARMONi-3 Phase 3 Clinical Trial

1L Metastatic Squamous NSCLC

NCT05899608: 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 250+ patients in the U.S., Canada and Europe; the overall study will include over 400 patients worldwide.

KEY ELIGIBILITY CRITERIA

• Metastatic (Stage IV) NSCLC
• Histologically or cytologically confirmed squamous NSCLC
• Patients must have Tumor Proportion Score (TPS) with PD-L1 expression percent
• No prior systemic treatment for metastatic NSCLC
• No histologic or cytopathologic evidence of the presence of small cell lung carcinoma, or non-squamous NSCLC histology
• No known actionable genomic alterations in EGFR, ALK, ROS1 or genes for which first-line approved therapies are available
• No radiologically documented evidence of major blood vessel invasion, encasement by cancer, or evidence of intratumor cavitation
• No symptomatic CNS metastases or CNS metastasis ≥1.5 cm
• No history of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks
  (including GI bleeding, hemoptysis)

For additional information on the HARMONi-3 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”).