Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its pipeline candidate LAE002 (afuresertib) in combination with fulvestrant. This new treatment regimen targets HR+/HER2- locally advanced or metastatic breast cancer. The multi-center, randomized, double-blinded, placebo-controlled Phase III study aims to evaluate the anti-tumor efficacy and safety of the combination therapy in patients with PIK3CA/AKT1/PTEN-altered HR+/HER2- locally advanced or metastatic breast cancer (LA/mBC). The combination has previously shown promising anti-tumor efficacy along with a favorable tolerability and safety profile in a Phase Ib study.
LAE002 (afuresertib) is an oral AKT inhibitor that was in-licensed from the Swiss pharmaceutical giant Novartis. It is currently under various clinical investigations as part of combination therapies for a range of cancers, including ovarian cancer, prostate cancer, breast cancer, and PD-1/PD-L1 drug-resistant solid tumors.
