# HARMONi-3

Source: https://onco.cc/trials/harmoni-3/  
OnCo record `harmoni-3` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The global test of whether ivonescimab plus chemotherapy beats the Keytruda-chemotherapy standard. An interim look in May 2026 fell short on progression; final results are due later in 2026.

## Summary

Interim analysis (May 2026) did not reach statistical significance for PFS; the company expects final PFS and interim OS readouts in 2026. The FDA has set a PDUFA date of 14 November 2026 for a separate BLA based on HARMONi (EGFR-mutant, post-TKI), where the Western-subgroup OS hazard ratio improved to 0.76 without statistical significance.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-06
- Registry id: NCT05899608
- Phase: 3
- Setting: First-line metastatic squamous and non-squamous NSCLC, global: ivonescimab + chemotherapy vs pembrolizumab + chemotherapy
- Sponsor: Summit Therapeutics
- Enrolled: 1080
- Result: Interim PFS not statistically significant (May 2026); final readouts pending.
- Outcomes: Progression-free survival (interim analysis, May 2026): Ivonescimab + chemotherapy vs Pembrolizumab + chemotherapy
- Replication: Ongoing; interim PFS analysis in 2026 did not meet significance per the sponsor; OS pending.

## Sources

- ClinicalTrials.gov NCT05899608: https://clinicaltrials.gov/study/NCT05899608
- Fierce Pharma on HARMONi OS update: https://www.fiercepharma.com/pharma/summit-therapeutics-updates-ivonescimab-survival-data-ahead-fda-decision-date

## Connected records

- cancers: [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [PD-L1-high non-small-cell lung cancer without a driver mutation](https://onco.cc/cancers/pdl1-high-nsclc/)
- technologies: [Bispecific antibodies](https://onco.cc/technologies/bispecific-antibody/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Ivonescimab](https://onco.cc/drugs/ivonescimab/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Summit Therapeutics](https://onco.cc/companies/summit-therapeutics/)
- ideas: [Confirm ultra-low-dose immunotherapy so it can be afforded where most patients live](https://onco.cc/ideas/idea-tr1-low-dose-immunotherapy-for-lmic/)
- trials: [HARMONi-A](https://onco.cc/trials/harmoni-a/)

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