LAEKNA-B(02105): The Phase III clinical trial (AFFIRM-205) of LAE 002 (Afuresertib) achieved the primary endpoint of progression-free survival (PFS).

LAEKNA-B (02105) announced that in the Phase III clinical trial (AFFIRM-205) of LAE 002 (afuresertib) in combination with fulvestrant, conducted in patients with HR+/HER2- locally advanced or metastatic breast cancer (LA/mBC) who had disease progression after previous treatment with or without combination therapy with CDK4/6 inhibitors and with PIK3CA/AKT1/PTEN alterations, strong positive top-line results were achieved. The key study successfully met its primary endpoint - showing a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to the control group. The Phase III clinical trial (AFFIRM-205) was a multicenter, randomized, double-blind, placebo-controlled pivotal study designed to evaluate the anti-tumor efficacy and safety of the combination therapy. A total of 261 subjects were enrolled, with 70.5% of subjects having received prior treatment with CDK4/6 inhibitors. The study met its primary endpoint, with a median PFS of 7.6 months in the LAE 002 (afuresertib) plus fulvestrant group compared to 2.0 months in the placebo plus fulvestrant group, HR=0.33 (p<0.0001). The once-daily oral treatment with LAE 002 (afuresertib) was well tolerated by patients, with a very low proportion of treatment discontinuation due to adverse events. The overall safety profile was consistent with previous data on the combination therapy. Detailed study results will be presented at an upcoming international scientific conference. Based on the positive results of this Phase III pivotal study, the group will collaborate with Qilu Pharmaceutical Co., Ltd. (Qilu Pharma) to submit a New Drug Application (NDA) for LAE 002 (afuresertib) to the Center for Drug Evaluation of the National Medical Products Administration (NMPA) in China in the near future. The group signed an exclusive license agreement with Qilu Pharma for the China region in November 2025. Under the agreement, the group has the right to receive up to a total of RMB 2.045 billion in upfront and milestone payments. The group is entitled to receive tiered sales 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 PIK3CA, AKT1, or PTEN alterations.