---
title: "AKESO announces results of its first global multi-center Phase III clinical study: primary endpoint achieved"
description: "AKESO announced the results of the global multicenter Phase III clinical study HARMONi for Ivosidenib at the World Lung Cancer Conference. The study showed that after a median follow-up of 13.7 months"
type: "news"
locale: "en"
url: "https://longbridge.com/en/news/256276815.md"
published_at: "2025-09-07T14:03:21.000Z"
---

# AKESO announces results of its first global multi-center Phase III clinical study: primary endpoint achieved

> AKESO announced the results of the global multicenter Phase III clinical study HARMONi for Ivosidenib at the World Lung Cancer Conference. The study showed that after a median follow-up of 13.7 months, the Ivosidenib combined with chemotherapy regimen significantly improved OS data in patients with disease progression after third-generation EGFR-TKI treatment, particularly notable in the North American population. Ivosidenib is the world's first PD-1/VEGF dual antibody drug, showing potential to replace K drug

On September 7th, AKESO announced the updated data from the global multicenter Phase III clinical study HARMONi of Ivosidenib at the World Lung Cancer Conference. The study evaluated the efficacy and safety of Ivosidenib combined with chemotherapy in patients with disease progression after third-generation EGFR-TKI treatment. The results showed a median follow-up time of 13.7 months, with significant improvement in OS data, particularly notable survival benefit data in the North American population. Ivosidenib is the world's first PD-1/VEGF dual antibody drug. Last year, in the domestic registrational Phase III clinical study of Ivosidenib as a monotherapy for PD-L1 positive non-small cell lung cancer, its PFS was longer than Merck's PD-1 Pembrolizumab, demonstrating the potential to replace Keytruda. Ivosidenib gained fame in one battle, becoming the hottest dual antibody globally

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> **Disclaimer**: This article is for reference only and does not constitute any investment advice.