LAE002 (Afuresertib), a Novel Pan-AKT Inhibitor from Laekna, Achieves Primary Endpoint in Phase III AFFIRM-205 Trial for HR+/HER2- Metastatic Breast Cancer with 67% Reduction in Disease Progression or Death Risk

April 15, 2026Laekna Therapeutics(Stock Code: 2105.HK) officially announced that its self-developedThe pivotal Phase III AFFIRM-205 study of LAE002 (afuresertib), a next-generation potent AKT inhibitor, in combination with fulvestrant for the treatment of HR+/HER2- locally advanced or metastatic breast cancer, has achieved positive topline results, successfully meeting the pre-specified primary endpoint.The study confirmed that the LAE002 combination regimen can bring highly statistically significant and clinically valuable progression-free survival (PFS) benefits to patients with endocrine resistance, which is expected to completely reshape the treatment landscape for HR+/HER2- breast cancer after resistance.

AFFIRM-205 is a multicenter, randomized, double-blind, placebo-controlled pivotal registration clinical study, enrolling a total of 261 patients with HR+/HER2- locally advanced or metastatic breast cancer who had disease progression after prior endocrine therapy with or without CDK4/6 inhibitors and harbored PIK3CA/AKT1/PTEN gene alterations. Among the enrolled population, 70.5% of participants had previously received CDK4/6 inhibitor treatment, closely reflecting the current real-world clinical practice.

Core data from the study demonstrate breakthrough therapeutic benefits: The median PFS in the LAE002 plus fulvestrant group reached 7.6 months, compared to only 2.0 months in the placebo plus fulvestrant group, with the experimental group reducing the risk of disease progression or death by 67% (HR=0.33, p<0.0001), successfully achieving the primary endpoint of the study. In terms of safety, the once-daily oral dosing regimen of LAE002 was well-tolerated, with a very low rate of treatment discontinuation due to adverse events. The overall safety profile was highly consistent with previous clinical study data, and no new safety signals were identified. Detailed data from the study will be officially presented at an upcoming top-tier international oncology conference.

As a core innovative product independently developed by Laekna Therapeutics, LAE002 is a potent inhibitor that can simultaneously target all subtypes of AKT1, AKT2, and AKT3.It is also one of the only two AKT inhibitors currently in late-stage clinical development for breast cancer and prostate cancer globally.Breast cancer is the most commonly diagnosed malignant tumor in women globally. The HR+/HER2- subtype accounts for 70% of breast cancer patients in China, and approximately 50% of these patients have abnormalities in the PIK3CA/AKT1/PTEN pathway, which is also the core mechanism leading to resistance to endocrine therapy and CDK4/6 inhibitor treatment. Currently, in clinical practice, the treatment options for such resistant patients are very limited, representing a significant unmet medical need.

Based on the positive results of this Phase III study,Laekna Therapeutics will partner with Qilu Pharmaceutical to submit a New Drug Application (NDA) for LAE002 to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China in the near future.In November 2025, the two parties had reached an exclusive licensing agreement, under which Qilu Pharmaceutical obtained the exclusive rights for the development and commercialization of the product in China. Meanwhile, Laekna Therapeutics plans to actively seek global partners outside of China to accelerate the global rollout of this innovative therapy.

Dr. Xiangyang Lü, Chairman and CEO of Laekna Therapeutics, said,The success of LAE002 in Phase III clinical trials has brought significant clinical benefits to breast cancer patients, with top-line results clearly demonstrating its best-in-class efficacy and safety. The company will promote this innovative therapy to benefit more patients worldwide through an open and innovative collaboration model. Industry insiders noted that the success of this study represents a milestone breakthrough in Laekna Therapeutics' R&D pipeline and is expected to establish a new standard for later-line treatment for HR+/HER2- drug-resistant breast cancer patients.