LAEKNA achieved significant improvement in PFS, reaching the primary endpoint in Phase III clinical trial for breast cancer

LAEKNA-B (02105.HK) announced that the Phase III clinical trial "Phase III Clinical Trial (AFFIRM-205)" of LAE002 (afuresertib) in combination with Fulvestrant, conducted in HR+/HER2- locally advanced or metastatic breast cancer ("LA/mBC") patients who experienced disease progression after prior treatment with endocrine therapy with or without CDK4/6 inhibitors, and with PIK3CA/AKT1/PTEN alterations, has achieved strong positive top-line results.

This pivotal study successfully met its primary endpoint, demonstrating 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) is a multicenter, randomized, double-blind, placebo-controlled pivotal study designed to evaluate the antitumor efficacy and safety of this combination therapy. A total of 261 subjects were included, of which 70.5% had previously received CDK4/6 inhibitor treatment