LAE002 (Afuresertib) Achieves Primary Endpoint in Phase III AFFIRM-205 Trial for HR+/HER2- Advanced Breast Cancer with PIK3CA/AKT1/PTEN Alterations

Intelligent Finance APP News, Laekna Therapeutics-B (02105) announced that the Phase III clinical trial ("Phase III Clinical Trial (AFFIRM-205)") of LAE002 (afuresertib) in combination with fulvestrant has achieved strong positive topline results. This pivotal study successfully met its primary endpoint - demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to the control group, in HR+/HER2- locally advanced or metastatic breast cancer (LA/mBC) patients with disease progression after prior endocrine therapy with or without CDK4/6 inhibitors, accompanied by PIK3CA/AKT1/PTEN alterations.

Phase II Clinical Trial (AFFIRM-205) is a multicenter, randomized, double-blind, placebo-controlled pivotal study designed to evaluate the antitumor efficacy and safety of the combination therapy. A total of 261 subjects were enrolled, with 70.5% having previously received CDK4/6 inhibitor treatment.

.The study met its primary endpoint, with a median PFS of 7.6 months in the LAE002 (afuresertib) plus fulvestrant group compared to 2.0 months in the placebo plus fulvestrant group, HR=0.33 (p-value<0.0001).

Once-daily oral administration of LAE 002 (afuresertib) was well-tolerated by patients, with a very low rate of treatment discontinuation due to adverse events. The overall safety profile was consistent with previous data evaluating this combination therapy.

Detailed study results will be presented at an upcoming international scientific conference. Based on the positive outcomes of this pivotal Phase III study, the Group, in collaboration with Qilu Pharmaceutical Co., Ltd. (Qilu Pharmaceutical), plans to submit a New Drug Application (NDA) for LAE002 (afuresertib) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China in the near future.

This group and Qilu Pharmaceutical Co., Ltd. signed an exclusive licensing agreement (Licensing Agreement) for the China region in November 2025. According to the Licensing Agreement, this group is entitled to receive upfront and milestone payments totaling up to RMB 2.045 billion. The group is also entitled to receive tiered royalties on future net sales of LAE 002 (afuresertib) in the licensed territory, with royalty rates ranging from over ten percentage points to over twenty percentage points. The group plans to seek strategic partners outside of China to accelerate the development and commercialization of LAE 002 (afuresertib) in international markets. Overall, approximately 50% of breast cancer patients have alterations in PIK3CA, AKT1, or PTEN.