Qilu Pharmaceutical's $2.8B-Licensed AKT Inhibitor LAE002 (Afuresertib) Succeeds in Phase III Trial for HR+/HER2- Breast Cancer, NDA Filing Imminent

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 Progression-Free Survival（PFS）Aspect, compared with the control group, showedHighly Statistically Significant and Clinically Meaningful Improvement。

Source: Laekna Therapeutics Official WeChat

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 who have experienced disease progression after prior treatment with endocrine therapy, with or without CDK4/6 inhibitors. The study aims toEvaluate 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, the PFS of the placebo combined with fulvestrant group was 2.0 months,HR is0.33 (p<0.0001)。

AnIn terms of sexuality, patients treated with once-daily oral LAE002Well Tolerated, due to adverse eventsAnd discontinuation of treatmentExtremely low proportion。The overall safety profile is consistent with prior data evaluating this combination therapy.Consistent.

LAE002 is aAKT Potent Inhibitor, which can simultaneously inhibit 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 and prostate cancer.

In November 2025, Laekna Therapeutics entered into an exclusive licensing agreement with Qilu Pharmaceutical, granting the latter an exclusive license to research, develop, and commercialize LAE002 in China.The total amount is up to 2.045 billion yuan.。

The press release shows that, based on the positive results of this Phase III pivotal study, Laekna Therapeutics will collaborate with Qilu Pharmaceutical.Recently submitted LAE002 to the CDENew Drug Application。

Cover source: ZCool HaiLo

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