LAE002 (Afuresertib) Phase III AFFIRM-205 Trial in HR+/HER2- Locally Advanced or Metastatic Breast Cancer Completes Patient Enrollment

Intelligent Finance APP News, Laekna Therapeutics-B (02105) announced that the group has completed the enrollment for the Phase III clinical trial AFFIRM-205 of LAE002 (afuresertib) in combination with fulvestrant for the treatment of HR+/HER2- locally advanced or metastatic breast cancer (“LA/mBC”) patients with PIK3CA/AKT1/PTEN gene alterations.

Phase III Clinical Trial AFFIRM-205 is a multicenter, randomized, double-blind, placebo-controlled pivotal study designed to evaluate the anti-tumor efficacy and safety of the combination therapy. The group aims to announce the top-line data of this Phase III pivotal study in the first half of 2026 and submit a New Drug Application to the Center for Drug Evaluation of the National Medical Products Administration later in the same year. Laekna Therapeutics and Qilu Pharmaceutical Co., Ltd. signed an exclusive licensing agreement on November 12, 2025. According to the terms and conditions of the licensing agreement, Qilu Pharmaceutical has obtained the exclusive rights to research, develop, and commercialize LAE002 (afuresertib) in China (including mainland China, the Hong Kong Special Administrative Region, the Macao Special Administrative Region, and Taiwan region).