On July 2nd, 2024, the "Evaluation of the Effectiveness and Safety of Afuresertib+Fluvesatinib in the Treatment of Locally Advanced or Metastatic HR+/HER2- Breast Cancer After Standard Treatment Failure Phase III Clinical Trial" (AFFIRM-205) led by Academician Xu Binghe of the Cancer Hospital of the Chinese Academy of Medical Sciences was held in Beijing on June 23rd by the researchers.
More than 50 breast cancer experts from 47 national cancer research centers jointly reviewed the safety and efficacy data of the preliminary study and held in-depth discussions around the research plan and implementation strategy of the Phase III clinical trial.
According to the International Agency for Research on Cancer (IARC) of the World Health Organization, breast cancer ranks second among female cancers in China, with an estimated 357,000 new cases in 2022, of which about 62% of Chinese patients belong to the HR+/HER2- (hormone receptor-positive and human epidermal growth factor receptor 2-negative) molecular subtype. Although most of these breast cancer patients can benefit from first- or second-line endocrine + CDK4/6 inhibitors and/or chemotherapy, after a period of time, most patients may develop resistance, leading to treatment failure, and urgently need new treatment options after resistance.
The afuresertib (LAE002) from Eli-Kymab (2105.HK) is one of the only two AKT inhibitors in the world that are in or have completed critical clinical development stages for cancer. The results of the Ib phase study conducted earlier showed that compared with the single-agent treatment PFS of fluvesatinib for 3-4 months, the median PFS of afuresertib combined with fluvesatinib increased significantly to 7.3 months, while showing good safety.
Academician Xu Binghe stated that preliminary results of the Ib study showed the potential of AKT inhibitors for the treatment of breast cancer, especially for locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN mutations in HR+/HER2- patients. At the end of May, the first patient was dosed in AFFIRM-205 at the Cancer Hospital of the Chinese Academy of Medical Sciences, and all experts present looked forward to the next Phase III clinical trial.
Currently, the patient screening process for AFFIRM-205 in all 47 centers nationwide is proceeding smoothly. As of June 30th, 10 breast cancer patients have been screened for the study.
Afuresertib (LAE002) is one of the only two AKT inhibitors in the world that are in or has completed critical clinical development stages for cancer.
Afuresertib is a potent AKT inhibitor that inhibits all three AKT subtypes (AKT1, AKT2, and AKT3). According to public data, compared with other AKT inhibitors, afuresertib has many advantages, such as higher efficacy, better pharmacokinetics, more significant tumor suppression exposure, and better safety. Capivasertib is AstraZeneca's first approved AKT inhibitor and was approved by the FDA for the treatment of HR+/HER2- breast cancer in November 2023.
Eli-Kymab showcased the efficacy of afuresertib in a Phase Ib trial for HR+/HER2- breast cancer at the 2023 San Antonio Breast Cancer Symposium (SABCS), and the data was good. Therefore, it has initiated the critical Phase III study AFFIRM-205. Eli-Kymab will continue to conduct clinical trials for the treatment of breast cancer, prostate cancer, ovarian cancer, and PD-1/PD-L1-resistant solid tumors to meet unmet medical needs. In multiple clinical trials, afuresertib demonstrated good efficacy results in combination with other therapies.