- 58.1% of the subjects had alterations in the PIK3CA/AKT1/PTEN pathway, and 64.5% of the subjects had previously received CDK4/6 inhibitors.

- The confirmed ORR was 33.3%, with a clinical benefit rate of 66.7% and a PFS of 7.3 months.

- The bridging study of the CAPItello-291 Phase III trial in China reported a PFS of 5.7 months for the capivasertib/fluvestrant combination therapy group and a PFS of 1.9 months for the fluvestrant monotherapy group in patients with alterations in the PIK3CA/AKT1/PTEN pathway.

- Led by Academician Xu Binghe, the Phase III clinical trial AFFIRM-205 is progressing smoothly and ahead of schedule compared to the original plan.

On September 19, 2024 - At the recently held European Society for Medical Oncology (ESMO) Congress 2024, Laike Pharmaceutical (2105.HK) announced the final data of its innovative product LAE002 (afuresertib, an oral AKT inhibitor) in combination with fluvestrant (referred to as 'combination therapy') for the treatment of locally advanced or metastatic HR+/HER2- breast cancer patients who have failed standard therapy. In 18 breast cancer patients with PIK3CA/AKT1/PTEN mutations, the median progression-free survival (PFS) was 7.3 months.

This Phase Ib clinical trial is an open-label, single-arm study designed to evaluate the efficacy and safety of the combination therapy in HR+/HER2- breast cancer patients who experienced progression after 1-2 lines of endocrine therapy (with or without CDK4/6 inhibitors as first-line treatment) and/or ≤1 line of chemotherapy.

As of August 27, 2024, a total of 31 subjects were enrolled in this Ib study, including 28 from China and 3 from the United States. The median age of the subjects was 54 years. Among them, 71.0% of the subjects had received first-line treatment and 29.0% had received second-line treatment. 18 patients had alterations in the PIK3CA/AKT1/PTEN pathway, accounting for 58.1% of the subjects. 64.5% of the enrolled patients had previously received CDK4/6 inhibitor treatment. The median follow-up time was 17.3 months. Both the overall population of 31 subjects from China and the United States and the subgroup of patients with alterations in the PIK3CA/AKT1/PTEN pathway showed significant anti-cancer efficacy and good tolerability.

Among the 18 patients with PIK3CA/AKT1/PTEN mutations:

- The confirmed objective response rate (ORR) is 33.3%.

- The clinical benefit rate is 66.7%.

- The median progression-free survival (PFS) is 7.3 months.

- The China bridging study of the CAPItello-291 Phase III trial, which investigated capivasertib and fulvestrant combination therapy in patients with PIK3CA/AKT1/PTEN gene alterations, reported a PFS of 5.7 months for the combination therapy and 1.9 months for fulvestrant monotherapy [ESMOAsia2023capivasertib+fulvestrantforpatientswitharomataseinhibitor-resistantHR-positive/HER2-negativeadvancedbreastcancer:Phase3CAPItello-291trialChinesecohort].

Lai Kai Pharmaceuticals initiated the follow-up Phase III clinical trial AFFIRM-205 in China in May 2024. The trial is led by Academician Xu Binghe from the Cancer Hospital of the Chinese Academy of Medical Sciences and aims to treat HR+/HER2-negative breast cancer patients with PIK3CA/AKT1/PTEN alterations. The project is progressing smoothly and ahead of schedule.

"The Phase Ib data on the combination therapy presented at the ESMO conference, especially the positive efficacy and safety demonstrated in patients with PIK3CA/AKT1/PTEN alterations, gives us confidence in the positive outcome of AFFIRM-205 and the submission of the drug for market approval," said Dr. Lu Xiangyang, Chairman and CEO of Lai Kai Pharmaceuticals. "The Phase III clinical trial is currently progressing rapidly and efficiently in centers across the country, which is extremely exciting for us, and we will do our best to benefit patients as soon as possible."