LAEKNA-B (02105): The Phase III clinical trial (AFFIRM-205) of LAE002 (AFURESERTIB) for HR+/HER2- locally advanced or metastatic breast cancer has completed enrollment.

LAEKNA-B (02105) announced that the group has completed the enrollment of the phase III clinical trial AFFIRM-205 for the treatment of HR+/HER2- locally advanced or metastatic breast cancer ("LA/mBC") with PIK3CA/AKT1/PTEN gene alterations, using the combination of LAE002 (afuresertib) and fluorouracil. The phase III clinical trial AFFIRM-205 is a multicenter, randomized, double-blind, placebo-controlled pivotal study, aiming to evaluate the anti-tumor efficacy and safety of this combination therapy. The group aims to announce the topline data of this pivotal phase III study in the first half of 2026, and submit a new drug application to the China National Medical Products Administration Drug Evaluation Center later in the same year. The group signed an exclusive license agreement with Qilu Pharmaceutical Co., Ltd. on November 12, 2025. According to the terms and conditions of the license agreement, Qilu Pharmaceutical has obtained the exclusive license to conduct research, development, and commercialization of LAE002 (afuresertib) in China (including mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan).