Gelonghui, May 30丨Laikai Pharmaceutical-B (02105.HK) announced that LAE 002 (afuresertib, an oral AKT inhibitor) combined with fluvirizin (“combination therapy”) against PIK3CA/AKT1/PTEN-altered HR+/HER2-locally advanced or metastatic breast cancer (“LA/m BC”) in China has initiated patient recruitment and completed the first patient enrollment (“Phase III AFFIRM- Clinical Trial”) 205”).

The phase III clinical trial, AFFIRM-205, is a multi-center, randomized, double-blind, placebo-controlled key study to further evaluate the anti-tumor efficacy and safety of combination therapy.

In a phase Ib study involving 20 patients from the US and China, combination therapy showed positive anti-cancer efficacy and was well tolerated and safe. The data was presented at the 2023 San Antonio Breast Cancer Conference (SABCS) poster panel session in December 2023. The group also recruited 11 additional subjects in the phase Ib study, further confirming the positive anti-cancer efficacy and good tolerability safety observed in the early stages, and plans to release clinical data on all subjects and biomarker positive subjects in the phase Ib study at an academic conference in the second half of 2024. The Group plans to bring this precision therapy to HR+/her2-la/MBC patients in need of novel treatment options.