The trial assessed ivonescimab against pembrolizumab monotherapy for locally advanced or metastatic NSCLC. Credit: Robina Weermeijer on Unsplash.

Summit Therapeutics has revealed that its Phase III HARMONi-2 (AK112-303) clinical trial of ivonescimab in patients with PD-L1 positive non-small cell lung cancer (NSCLC) in China met the primary endpoint.

Sponsored and analysed by Akeso, the single-region, multicentre, double-blinded trial assessed ivonescimab against pembrolizumab monotherapy in locally advanced or metastatic NSCLC patients.

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At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab achieved a clinically meaningful improvement in progression free survival (PFS) compared to pembrolizumab.

This PFS benefit was in line across various clinical subgroups, including those with both low and high PD-L1 expression, different histologies, and other high-risk patients.

The landmark study is particularly significant as there are no other known Phase III clinical trials in NSCLC that have demonstrated such a statistically significant improvement in PFS compared to pembrolizumab in a head-to-head comparison.

In China, ivonescimab is approved in combination with chemotherapy based on the results of the HARMONi-A trial.

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Summit Therapeutics CEO and president Dr Maky Zanganeh said: “HARMONi-2 clearly demonstrates that ivonescimab is the next generation in PD-1 directed immunotherapy, and its potential to make a significant difference in the lives of patients with lung cancer and prospectively other solid tumours.

“We want to congratulate our partners at Akeso for this incredible result and their work to advance the patient-friendly standards of care today and well into the future. This result validates Team Summit’s present-time intention to execute a development plan worthy of ivonescimab’s emergent potential, including clinical trials in both NSCLC and other tumours where ivonescimab can improve upon existing standards of care.”