Akeso has secured NMPA authorisation to use ivonescimab plus platinum-based chemotherapy as a first-line treatment for advanced squamous NSCLC in China, the third ivonescimab-containing indication approved since May 2024. The approval was supported by the HARMONi-6 multicentre Phase III trial in China, which showed statistically significant and clinically meaningful improvements in progression-free and overall survival versus a tislelizumab-plus-chemotherapy regimen. Ivonescimab (also known as SMT112) remains investigational outside China; Akeso reports over 4,000 trial patients and more than 70,000 commercial uses in China.
Akeso Wins NMPA Approval for Ivonescimab Plus Chemotherapy as First-Line Treatment for Squamous NSCLC in China
The HARMONi-6 trial included patients with locally advanced or metastatic squamous NSCLC
Akeso, a partner of Summit Therapeutics, has received authorisation from China’s National Medical Products Administration (NMPA) to use ivonescimab in combination with platinum-based chemotherapy as a first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC). This marks the third NMPA-approved indication for an ivonescimab-containing regimen since the molecule's initial authorisation in May 2024.
Ivonescimab is an investigational bispecific antibody. The latest marketing authorisation was based on findings from HARMONi-6, a multicentre Phase III study conducted in China. Akeso reports that all data for HARMONi-6 were generated, managed and analysed solely by the company.
The HARMONi-6 trial randomised patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression, to receive either ivonescimab plus platinum-based chemotherapy or a comparator regimen of the programmed cell death protein 1 (PD-1) inhibitor tislelizumab plus platinum-based chemotherapy.
According to the trial results, the ivonescimab-containing combination produced statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS) versus the tislelizumab-plus-chemotherapy arm.
The safety profile observed in HARMONi-6 was reported as consistent with earlier studies of ivonescimab plus chemotherapy, with no new safety signals highlighted in the company announcement.
Bob Duggan, Summit Therapeutics chairman and co-CEO, said: Today's approval in China marks another extraordinary milestone for ivonescimab and reinforces the strength of the clinical evidence generated to date. HARMONi-6 is the first known Phase III study in NSCLC — or any tumour type — to demonstrate a statistically significant and clinically meaningful overall survival benefit over an anti-PD-(L)1 antibody plus chemotherapy regimen in a head-to-head setting.
Referred to as SMT112 in Summit Therapeutics' licensed territories, ivonescimab remains an investigational therapy and is not approved by regulatory authorities in the United States or Europe. Akeso states that more than 4,000 patients have received ivonescimab in clinical studies worldwide and that the antibody has been used commercially in China in excess of 70,000 patients.
Note: This report is based on a Pharmaceutical Technology article originally published by GlobalData's Pharmaceutical Technology brand.
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