Core Insights - The study published in Nature Communications indicates that the combination therapy of Afuresertib and Fulvestrant shows promising anti-tumor activity and good safety profiles in patients with HR+HER2- advanced breast cancer [1][2]. Group 1: Clinical Trial Results - The median progression-free survival (PFS) for LAE002 (Afuresertib) reached 8.2 months, demonstrating significant therapeutic potential [2]. - The confirmed objective response rate (ORR) was 33.3% in patients with alterations in the PIK3CA/AKT1/PTEN pathways [2]. - In the population with ESR1 mutations and PIK3CA/AKT1/PTEN pathway alterations, the confirmed ORR reached 42.9% [2]. Group 2: Future Developments - A Phase III clinical trial (AFFIRM-205) led by Professor Xu is currently progressing, targeting HR+/HER2- locally advanced or metastatic breast cancer patients with PIK3CA/AKT1/PTEN pathway alterations [3]. - The trial completed patient enrollment in December 2025, with topline data expected to be released in the first half of this year, and a New Drug Application (NDA) planned for submission to the Chinese National Medical Products Administration [3]. - In November 2025, the company signed an exclusive licensing agreement with Qilu Pharmaceutical for the commercialization of LAE002 (Afuresertib) in China [3].
来凯医药(2105.HK)临床研究登上《自然-通讯》杂志LAE002(Afuresertib)联合方案对晚期乳腺癌展现令人鼓舞的疗效和安全性