Summit Therapeutics’ partner Akeso has secured China’s National Medical Products Administration (NMPA) authorisation for the use of ivonescimab in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (NSCLC) patients.
The decision marks the third NMPA-approved indication for an ivonescimab-containing regimen in the country since the molecule first received authorisation in May 2024.
Ivonescimab is described as an investigational bispecific antibody. The latest marketing authorisation is based on data from the HARMONi-6 multi-centre Phase III study that was conducted in China.
Data for the study were generated, managed, and analysed solely by Akeso.
The HARMONi-6 trial compared ivonescimab in combination with platinum-based chemotherapy against a regimen of the programmed cell death protein 1 (PD-1) inhibitor tislelizumab with platinum-based chemotherapy.
It included patients with locally advanced or metastatic squamous NSCLC, regardless of PD-L1 expression.
The study showed that the combination with ivonescimab produced statistically significant and clinically meaningful improvements in both progression-free survival and overall survival when compared to the PD-1 inhibitor-based regimen.
The safety profile observed was said to be consistent with earlier studies of ivonescimab combined with chemotherapy.
Summit Therapeutics chairman and co-CEO Bob Duggan 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.”
Ivonescimab, which is also referred to as SMT112 in Summit Therapeutics’ licence regions, remains an investigational therapy and is not approved by regulatory authorities in the US or Europe.
As noted by Akeso, more than 4,000 patients have been treated with ivonescimab in clinical studies worldwide, and over 70,000 in a commercial setting in China.
