# HARMONi-A

Source: https://onco.cc/trials/harmoni-a/  
OnCo record `harmoni-a` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first phase 3 win for ivonescimab, in lung cancer that has stopped responding to EGFR pills, and the basis of its first approval in China.

## Summary

322 patients. Median progression-free survival 7.1 versus 4.8 months (hazard ratio 0.46) with benefit across subgroups including patients who had received third-generation EGFR inhibitors; published in JAMA in 2024. NMPA approval May 2024, the first for any PD-1 x VEGF bispecific antibody. Summit's global HARMONi trial in the same setting met progression-free survival but not overall survival at its 2025 analysis, the basis of a US filing with a November 2026 action date.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Tags: china
- Registry id: NCT05184712
- Phase: 3
- Setting: EGFR-mutant non-squamous NSCLC after progression on an EGFR TKI, China: ivonescimab or placebo plus pemetrexed and carboplatin
- Sponsor: Akeso
- Enrolled: 322
- Result: PFS 7.1 vs 4.8 months, HR 0.46.
- Outcomes: Progression-free survival: Ivonescimab + chemotherapy 7.1 months vs Placebo + chemotherapy 4.8 months, HR 0.46

## Sources

- ClinicalTrials.gov NCT05184712: https://clinicaltrials.gov/study/NCT05184712
- JAMA 2024: https://doi.org/10.1001/jama.2024.10613

## Connected records

- trials: [HARMONi-2](https://onco.cc/trials/harmoni-2/), [HARMONi-3](https://onco.cc/trials/harmoni-3/)
- cancers: [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Bispecific antibodies](https://onco.cc/technologies/bispecific-antibody/)
- targets: [EGFR](https://onco.cc/targets/egfr/), [PD-1](https://onco.cc/targets/pd1/), [VEGF / VEGFR](https://onco.cc/targets/vegf/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Ivonescimab](https://onco.cc/drugs/ivonescimab/), [Pemetrexed](https://onco.cc/drugs/pemetrexed/)
- companies: [Akeso](https://onco.cc/companies/akeso/), [Summit Therapeutics](https://onco.cc/companies/summit-therapeutics/)
- people: [Li Zhang](https://onco.cc/people/zhang-li-sysucc/), [Michelle Xia (Xia Yu)](https://onco.cc/people/xia-michelle/), [Wenfeng Fang](https://onco.cc/people/fang-wenfeng/)
- key papers: [Ivonescimab Plus Chemotherapy in Non-Small Cell Lung Cancer With EGFR Variant: A Randomized Clinical Trial](https://onco.cc/key-papers/paper-harmoni-a-jama-2024/)

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