Afuresertib

Feb 12, 2026 — On February 6, 2026, an article titled "Afuresertib plus fulvestrant for pretreated HR-positive, HER2-negative, advanced breast cancer: a phase Ib trial" was published in Nature Communications, an international scientific journal. The article primarily reports the results of this Phase Ib clinical trial, which evaluated afuresertib in combination with fulvestrant for the treatment of pretreated HR-positive/HER2-negative advanced breast cancer. The study was led by Professor Xu Binghe, an academician of the Chinese Academy of Engineering and from the Cancer Hospital of the Chinese Academy of Medical Sciences. The findings indicate that this combination regimen was well-tolerated and had promising antitumor activities against pretreated, advanced HR-positive, HER2-negative breast cancer. LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. • In this study, the combination of afuresertib and fulvestrant demonstrated promising efficacy, with a median progression-free survival (PFS) of 8.2 months. • Among patients with PIK3CA/AKT1/PTEN alternations, the confirmed ORR reached 33.3%. • In the subgroup with ESR1 mutations plus PIK3CA/AKT1/PTEN pathway alterations, the confirmed ORR was as high as 42.9%. Professor Xu Binghe and his team concluded: “This phase Ib study confirms the promising efficacy and favorable safety profile of afuresertib plus fulvestrant in pretreated HR+/HER2- advanced breast cancer patients, especially among patients with PIK3CA/AKT1/PTEN alterations. The well-tolerated safety profile of afuresertib, coupled with the convenience of once-daily oral dosing, makes it an attractive treatment option for this patient population. The promising clinical data strongly supports further development and application of afuresertib in the treatment of advanced breast cancer.” Currently, the phase III trial AFFIRM-205, led by Professor Xu Binghe, to evaluate LAE002 (afuresertib) plus fulvestrant in patients with PIK3CA/AKT1/ PTEN alterations and HR+/HER2- locally advanced or metastatic breast cancer, is progressing smoothly. Patient enrollment for this phase III study was completed in December 2025. The study aims to report topline results in the first half of this year, with plans to submit a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration later this year. In November 2025, Laekna entered into an exclusive licensing agreement with Qilu Pharma to accelerate the commercialization for LAE002 (afuresertib). – End – Contact Us IR ir@laekna.com Corporate and Business Development BD@laekna.com About Laekna Stock Code: 2105.HK Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapeutics to patients with metabolic diseases, cancer and liver fibrosis around the world. As of June 30, 2025, Laekna has initiated seven clinical trials for LAE102, LAE002 (afuresertib) and other drug candidates to address unmet medical needs in obesity and cancers. LAE102 is our internally discovered antibody against ActRIIA. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass, this positions LAE102 as a promising drug candidate for achieving quality weight control. We are advancing the Phase I clinical trials for obesity indication in both China and the U.S. In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company to support and accelerate global clinical development of LAE102 for the treatment of obesity. In addition to LAE102, LAE103 is our internally discovered ActRIIB-selective antibody, LAE123 is an ActRIIA/IIB dual antagonistic monoclonal antibody. Laekna has established a comprehensive ActRII portfolio and is actively advancing these drug candidates to clinical studies as novel therapies for muscle and other disease indications. In the cancer area, Laekna has built a comprehensive portfolio of drug candidates including LAE002(afuresertib), LAE001 and other clinical and pre-clinical drug candidates. LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 in patients with HR+/HER2- breast cancer and the study recruitment is on track. Laekna, Inc. (2105.HK) was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023. For more information, please visit: https://www.laekna.com/ or https://www.linkedin.com/company/74110713/ Forward-Looking Statements This press release may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on Laekna’s current beliefs, assumptions and expectations, commonly identified by words such as "would", "may", "expects", "believes", "plans", "intends", "projects" and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law.