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Clinical Trials Overview

Summit Clinical Trials for Ivonescimab (SMT112)

Ivonescimab: PD-1/VEGF Bispecific Antibody Being Studied in Phase 3 Non-small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC) Trials.

Brings two validated mechanisms in oncology1-3 into ONE novel tetravalent molecule1.


Phase 3 Trial: 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.
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HARMONi Fact Sheet (opens in new window)

Phase 3 Trial: 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.
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HARMONi-3 Fact Sheet (opens in new window)

Phase 3 Trial: 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.
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HARMONi-7 Fact Sheet (opens in new window)

Phase 3 Trial: 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)

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Ivonescimab Mechanism of Action

For More Information on Ivonescimab click here (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).


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, 2025.

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.

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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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