Laekna, Inc. announced that the results of a phase Ib study to evaluate the efficacy and safety of afuresertib (LAE002, an oral pan-AKT inhibitor) plus fulvestrant in patients with locally advanced or metastatic HR+/HER2- breast cancer who failed standard of care therapies were presented during a poster spotlight session at the 2023 San Antonio Breast Cancer Symposium (SABCS). The study results are summarized as follows: LAE205INT3101 (NCT04851613) is an ongoing phase Ib/III global study. The data presented is from the phase Ib single arm, open-label study to evaluate the efficacy and Safety of the combination therapy of afuresertib (125mg QD) plus fulvestrant (500mg Q28 days) in patients with HR+/HER2- LA/mBC who have disease progression after 1-2 prior lines of ET with or without a CDK4/6 inhibitor (1 line), and/or 1 line of chemotherapy.

As of the data cut-off date of October 16, 20 patients were enrolled, including 17 Chinese patients and 3 American patients. There were 19 female patients and 1 male patient enrolled. The median age of all patients was 53 years old.

80% of the patients had received one line of therapy, and 20% had received two lines of therapy. 70% of the patients were previously treated with CDK4/6 inhibitors. The median duration of follow-up was 11 months.

Efficacy. Best overall response:6 patients had confirmed partial response (30%), 10 patients had stable disease (50%), and 4 patients had progressive disease (20%). The confirmed objective response rate was 30% (95%CI, 11.9, 54.3) and the disease control rate was 80%.

The median PFS was 7.3 months (95%CI, 3.7, NE). Among the 11 patients with specific biomarker alterations (PIK3CA/AKT1/PTEN), the confirmed objective response rate was 45.4% (95%CI, 16.7, 76.6), the disease control rate was 82%, and the median PFS was 7. 3 months (95%CI,3.6, 8.2). Among the 17 Chinese patients, the confirmed objective response rate was 29.4% (95% CI, 10.3, 60.0), the disease control rate was 82.4%, and the median PFS were 7.3 months (95%CI, 3.6, 8.2).