LAE002 (Afuresertib) Achieves Primary Endpoint in Phase III AFFIRM-205 Trial; Laekna Ltd. and Qilu Pharmaceutical to Submit NDA

On April 15, Laekna Therapeutics-B (02105) announced positive results from the Phase III clinical trial (AFFIRM-205) of its drug LAE002 (Afuresertib), successfully achieving the primary endpoint of progression-free survival (PFS). In patients with HR+/HER2- locally advanced or metastatic breast cancer harboring PIK3CA/AKT1/PTEN gene alterations, the drug demonstrated a highly statistically significant and clinically meaningful benefit. The trial results showed that the median PFS was 7.6 months in the LAE002 plus fulvestrant group, compared to 2.0 months in the placebo group, with a hazard ratio (HR) of 0.33 (p-value <0.0001).

The announcement mentioned that a total of 261 subjects were enrolled, of which 70.5% had previously received CDK4/6 inhibitor treatment. Patients showed good tolerance to the once-daily oral administration of LAE002, with a very low rate of treatment discontinuation due to adverse events.

Based on this positive result, the company will jointly submit a New Drug Application for LAE002 to the National Medical Products Administration (NMPA) of China with Qilu Pharmaceutical Co., Ltd. According to the exclusive licensing agreement signed with Qilu Pharmaceutical, the company is entitled to receive upfront and milestone payments totaling up to 2.045 billion yuan and will collect tiered sales royalties on future net sales, with royalty rates ranging from over ten percent to over twenty percent.