Akeso's ivonescimab shows strong survival benefit in lung cancer trial

Akeso, Inc. has reported positive outcomes from its HARMONi-6/AK112–306 phase III trial for ivonescimab, which showed significantly prolonged progression-free survival (PFS) in patients with first-line advanced squamous non-small cell lung cancer (sq-NSCLC). The median PFS for the ivonescimab plus chemotherapy group was 11.14 months, compared to 6.9 months for the tislelizumab plus chemotherapy control group, representing a hazard ratio (HR) of 0.60 (P<0.0001). This translates to an improvement of 4.24 months in PFS.

The HARMONi-6 study met its primary endpoint, demonstrating statistically significant and clinically meaningful benefits across various subgroups, including those with different PD-L1 expression levels and high-risk patients. For PD-L1 TPS<1%, mPFS was 9.9 months vs 5.7 months (HR=0.55), and for PD-L1 TPS≥1%, mPFS was 12.6 months vs 8.6 months (HR=0.66). The drug also exhibited a favorable safety profile with no new safety signals.

The supplementary new drug application (sNDA) for this indication has been accepted by CDE, with Akeso highlighting ivonescimab's breakthrough clinical value and its potential to address existing treatment gaps in sq-NSCLC. Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug, with over 30 ongoing clinical trials across various indications.