China's First Oral AKT Inhibitor for Breast Cancer Achieves Positive Phase III Results in Combination Therapy

On April 15, Laekna Therapeutics announced,LAE002（afuresertib）In combination with fulvestrant,TreatmentHR+/HER2- Breast Cancer Phase IIIClinical Trial（AFFIRM-205）Achieve the primary endpoint，In terms of progression-free survival (PFS), compared with the control group, it showedHighly Statistically Significant and Clinically Meaningful Improvement。

Source: Laekna Therapeutics Official WeChat

LAE002 is a potent AKT inhibitor that simultaneously suppresses all three AKT subtypes (AKT1, AKT2, and AKT3). It is also one of only two AKT inhibitors globally in late-stage clinical development for breast cancer and prostate cancer.In November 2025, Laekna Therapeutics signed an exclusive licensing agreement with Qilu Pharmaceutical, granting the latter the exclusive rights to research, develop, and commercialize Afuresertib in China. Laekna Therapeutics plans to actively seek partnerships with global partners outside of China.

AFFIRM-205 is a multicenter, randomized, double-blind, placebo-controlled pivotal study in HR+/HER2- locally advanced or metastatic breast cancer patients with PIK3CA/AKT1/PTEN alterations, whose disease has progressed after prior endocrine therapy with or without CDK4/6 inhibitors. The study aims toEvaluation of the Antitumor Efficacy and Safety of LAE002 in Combination with Fulvestrant. A total of261 subjects, where 70.5% of the subjects had previously received CDK4/6 inhibitor treatment.

ConclusionThe results showed that the study achieved its primary endpoint,LAE002 in Combination with FulvestrantMedian PFS was 7.6 months, PFS was 2.0 months in the placebo plus fulvestrant group,HR is0.33 (p<0.0001)。

AnIn terms of full gender, patients treated with once-daily oral LAE002Well tolerated, due to adverse eventsAnd treatment was discontinuedExtremely low proportion。Overall Safety Profile Consistent with Prior Data Evaluating the Combination TherapyConsistent.