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Ivonescimab Outperforms Pembrolizumab in Phase III Lung Cancer Trial

Patients with locally advanced or metastatic non-small cell lung cancer now have a more effective treatment option, as Akeso’s ivonescimab has met the key secondary endpoint of overall survival in the HARMONi-2 trial, demonstrating a statistically significant improvement over the current standard-of-care, pembrolizumab.

Ivonescimab Outperforms Pembrolizumab in Phase III Lung Cancer Trial
Photo: Bio & News

The interim analysis, conducted by an Independent Data Monitoring Committee, confirms that the PD-1/VEGF bispecific antibody provides a meaningful survival benefit. This milestone follows the trial’s earlier success in May 2024, when ivonescimab reached its primary endpoint of progression-free survival with a median of 11.14 months, compared to 5.82 months for pembrolizumab.

Since receiving regulatory approval in China last year, the drug has changed clinical practice by offering a chemotherapy-free alternative for patients, including those with squamous histology. Dr. Yu Xia, CEO of Akeso, noted that these results reinforce the clinical value of the dual-mechanism therapy, which targets both immunotherapy and anti-angiogenesis. Detailed findings are expected to be presented at an upcoming international medical conference and submitted for peer-reviewed publication.

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