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# Akeso’s Ivonescimab Meets Endpoint in Lung Cancer
- URL: https://www.fdaweb.com/akesos-ivonescimab-meets-endpoint-in-lung-cancer/
- Published: 2025-04-23T12:00:00.000Z
- Updated: 2026-09-14T15:10:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159057

Akeso says its first-in-class PD-1/VEGF bispecific antibody ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous non-small cell lung cancer. The HARMONi-6 (AK112-306) trial showed that ivonescimab combined with chemotherapy significantly outperformed a control regimen of BeiGene’s Tevimbra (tislelizumab-jsgr) plus chemotherapy, extending progression-free survival (PFS) in a statistically significant and clinically meaningful way, according to the company. The findings were confirmed during the study’s first pre-specified interim analysis by an independent data monitoring committee.

In the head-to-head trial involving 532 patients, ivonescimab delivered clear PFS benefits across both PD-L1-positive and PD-L1-negative subgroups, the company says. Importantly, the combination therapy maintained a favorable safety profile, with no new safety signals emerging. Rates of serious adverse events and high-grade bleeding were comparable to the control group, it adds.

HARMONi-6 is the third successful Phase 3 trial for ivonescimab in the treatment of lung cancer and the second to show superiority over PD-1 inhibitors. This reinforces the drug’s potential to become a next-generation standard of care in non-small cell lung cancer treatment, according to Akeso. More detailed results from the HARMONi-6 study will be presented at a major medical conference later this year, it says.