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Ivonescimab Overview

Ivonescimab
Ivonescimab Mechanism of action (for Illustrative Purposes Only)

Cooperative Binding Offers Potential to Drive Synergistic Anti-Tumor Activity

MOA schema
VEGF icon VEGF Dimer T Cell icon PD-1 Receptor in T Cell
Images for illustrative purposes only.

Dual Blocking of PD-1 & VEGF

Increased Avidity in TME1*

VEGF-A efficiently enhances the binding affinity to PD-1 by several fold

Enhanced Activity of T Cells1*

VEGF dimer leads to potential interconnection of ivonescimab molecules, which may increase activity of T cells

T1/2 ~10 days2 and Fc-null region1

*in vitro

Clinical Trials

For additional information about clinical studies, submit a (opens in new window)Medical Information Form


Phase 3 Study: NCT06396065 (opens in new window)3-4

A Randomized, Double-blind, Multi-center, Phase 3 Clinical Trial of Ivonescimab 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.
Learn more (opens in new window).

HARMONi Fact Sheet (opens in new window)

Phase 3 Study: NCT05899608 (opens in new window)5-6

A Randomized, Double-blinded, Multiregional Phase 3 Trial of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer.
Learn more (opens in new window).

HARMONi-3 Fact Sheet (opens in new window)

Phase 3 Study: NCT06767514 (opens in new window)7-8

A Randomized, Double-blinded, Multiregional Phase 3 Trial 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.
Learn more (opens in new window).

HARMONi-7 Fact Sheet (opens in new window)

Phase 3 Study: NCT07228832 (opens in new window)9

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Trial of Ivonescimab in Combination with FOLFOX Versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer.
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HARMONi-GI3 Fact Sheet (opens in new window)

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

Abbreviations: EGFR-mutant=epidermal growth factor receptor mutation; EGFR-TKI=epidermal growth factor receptor-tyrosine kinase inhibitor; FOLFOX=oxaliplatin + leucorovin + 5-fluorouracil (5-FU); Fc=fragment crystallizable; PD-1=programmed cell death protein 1; PD-L1=programmed death-ligand 1; T1/2=Half life; TME=tumor microenvironment; VEGF=vascular endothelial growth factor.

References:

  1. Zhong T, et al. iScience. 2024;28(3):111722.

  2. Data on File 29. Summit Therapeutics Inc.

  3. HARMONi. ClinicalTrials.gov identifier: NCT06396065. https://clinicaltrials.gov/study/NCT06396065. Updated Mar 24, 2026. Accessed Apr 22, 2026.

  4. Goldman J, Passaro A, Laskin J, et al. Ivonescimab vs Placebo Plus Chemo, Phase 3 in Patients with EGFR+ NSCLC Progressed with 3rd gen EGFR-TKI treatment: HARMONi. Presented at WCLC 2025; September 6-9, 2025; Barcelona, Spain.

  5. HARMONi-3. ClinicalTrials.gov identifier: NCT05899608. https://clinicaltrials.gov/study/NCT05899608. Updated Jan 7, 2026. Accessed Apr 22, 2026.

  6. Zhang J, Cai J, Wang H, et al. A Randomized Phase 3 Study of Ivonescimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for the First-line treatment of Metastatic Non-small Cell Lung Cancer: HARMONi 3. Presented at ASCO 2025; May 30 - June 3, 2025; Chicago, IL.

  7. HARMONi-7. ClinicalTrials.gov identifier: NCT06767514. https://clinicaltrials.gov/study/NCT06767514. Updated Feb 24, 2026. Accessed Apr 22, 2026.

  8. Passaro A, Girard N, Rodriguez-Abreu D, et al. A Randomized Phase 3 Study of Ivonescimab Versus Pembrolizumab as First-Line Treatment of Metastatic Non-Small Cell Lung Cancer With High Tumor PD-L1 Expression: HARMONi-7. Presented at ELCC 2025; March 26-29, 2025; Paris, France.

  9. HARMONi-GI3. ClinicalTrials.gov identifier: NCT07228832. https://clinicaltrials.gov/study/NCT07228832. Updated Apr 6, 2026. Accessed Apr 22, 2026.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's NMPA.

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

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