Summit Clinical Trials for Ivonescimab (SMT112)

Ivonescimab: Most Advanced PD-1/VEGF Bispecific Antibody in the U.S. & EU.* Brings two validated mechanisms in oncology1-3 into ONE novel tetravalent molecule.

Phase 3 Study: NCT063960654

A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined with Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Have Progressed on or Following Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment.
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HARMONi Fact Sheet

Phase 3 Study: NCT058996085

A Randomized, Double-blinded, Multiregional Phase 3 Study of ivonescimab Combined with Chemotherapy versus pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer.
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HARMONi-3 Fact Sheet

Phase 3 Study: NCT067675146

A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression.
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HARMONi-7 Fact Sheet

For additional information on the HARMONi, HARMONi-3 or HARMONi-7 clinical trials, please contact medinfo@smmttx.com

Ivonescimab Mechanism of Action

For More Information on Ivonescimab click here

Ivonescimab is an investigational therapy that is not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA).

References

  1. Manegold C, et al. J Thorac Oncol 2017;12(2):194-207.
  2. Pardoll, D. Nat Rev Cancer 2012;12(4):252-64.
  3. Tamura R, et al. Med Oncol 2020;37(1):2.
  4. Phase III Study of AK112 for NSCLC Patients. ClinicalTrials.gov identifier: NCT06396065.
    https://clinicaltrials.gov/study/NCT06396065. (Accessed 2024, May 14).
  5. Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients.
    ClinicalTrials.gov identifier: NCT05899608. https://clinicaltrials.gov/study/NCT05899608. (Accessed on Jan. 16, 2025).
  6. HARMONi-7. ClinicalTrials.gov identifier: NCT06767514 Updated Jan 10, 2025 (Accessed on Jan. 10, 2025)

Abbreviations: PD-1, programmed death-1; VEGF, vascular endothelial growth factor; TPS, tumor proportion score; PD-L1, programmed death-ligand 1; EGFR-mutant, epidermal growth factor receptor mutation; EGFR-TKI, epidermal growth factor receptor- tyrosine kinase inhibitor; NSCLC, non-small cell lung cancer.

*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”).