LAEKNA-B (02105): Enrollment Completed for Phase III Clinical Trial (AFFIRM-205) of LAE002 (Afuresertib) in HR+/HER2- Locally Advanced or Metastatic Breast Cancer

Stock News

2025/12/15

LAEKNA-B (02105) announced that the group has completed patient enrollment for the Phase III clinical trial AFFIRM-205, evaluating LAE002 (afuresertib) in combination with fulvestrant for the treatment of HR+/HER2- locally advanced or metastatic breast cancer (LA/mBC) in patients with PIK3CA/AKT1/PTEN genetic alterations.

AFFIRM-205 is a multicenter, randomized, double-blind, placebo-controlled pivotal study designed to assess the antitumor efficacy and safety of the combination therapy. The group aims to release topline data from this Phase III pivotal study in the first half of 2026 and submit a new drug application to China's National Medical Products Administration later that year.

On November 12, 2025, the group entered into an exclusive licensing agreement with Qilu Pharmaceutical Co., Ltd. Under the terms of the agreement, Qilu Pharmaceutical obtained exclusive rights to research, develop, and commercialize LAE002 (afuresertib) in China, including the mainland, Hong Kong SAR, Macau SAR, and Taiwan region.

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