China-based Laekna Therapeutics has announced that its pan-AKT inhibitor, afuresertib (LAE002), met the primary endpoint in the Phase III AFFIRM-205 trial for HR+/HER2- breast cancer. The study demonstrated that afuresertib, combined with fulvestrant, significantly improved progression-free survival (PFS) compared to fulvestrant plus placebo in patients with PIK3CA/AKT1/PTEN alterations whose disease had progressed on prior endocrine therapy. The median PFS was 7.6 months for the combination versus 2.0 months for the control arm.

Afuresertib, originally acquired from Novartis, is one of only two AKT inhibitors in or completing late-stage oncology development globally. Based on the positive results, Laekna and its partner Qilu Pharmaceutical plan to submit a new drug application (NDA) to China's Centre for Drug Evaluation (CDE) in the near future. The drug was well-tolerated in the trial, with a low discontinuation rate due to adverse events. Laekna intends to seek global partners for the development of afuresertib outside of China.

PharmCube's NextBiopharm® database lists seven companies developing a total of four pan-AKT inhibitors. Click here to request a free trial for NextBiopharm®.