20 August 2025, Abbisko Therapeutics announced that the Center forDrug Evaluation (CDE) of the China National Medical Products Administration (NlPA) has cleared the lND application for Abbisko’sinvestigational oral PD-1 inhibitor, ABSK043, combined with Shanghai Alist Pharmaceuticals KRAS G12C inhibitor, glecirasib, for the treatment of NscLc patients with KRAS G12C mutation.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number:4008803716
WeChat ID: 17801183037
Email:myimmnet@163.com
About ABSK043
ABSK043 is a novel, oraly bioavailable, highly selective small molecule PD-L1 inhibitor wholly-owned by Abbisko Therapeutics. Tumor cellscan exploit immune checkpoints such as PD-1 and its ligand PD-L1 to evade immune detection and clearance, thereby suppressing or limitincI-cell responses, ABSK043 selecively binds to the PD-L1 receptor and induces its internaization from the cell surace, efectively inhilbitingthe PD-1/PD-L1 interaction and alleviating PD-L1-mediated suppression of T-cell activation. in preclinical models, ABSK043 hasdemonstrated anti-tumor eficacy comparable to approved PD-L1 antibodies. While several PD-1/PD-L1 monoconal antibodies have beerapproved woridwide, there are currently no approved orally bioavailable PD-1/PD-L1 small molecule drygs, ABSK043 is currently beingexplored in an ongoing Phase l clinical trial for advanced solid tumors in Australia and China.
In a phase I study (NCT04964375), ABSK043, an oral, potent, small-molecule PD-L1 inhibitor, exhibited preliminary efficacy.
Methods
Pts with advanced solid tumors were dosed with ABSK043 capsules ranging from 200 mg once daily (QD) to 1000 mg twice daily (BID), to evaluate the safety profile and preliminary efficacy. Furthermore assessed were pharmacodynamic (PD) indicators, such as T-cell function and surface PD-L1.
Results
As of the cutoff date (June 7, 2024), 77 pts were enrolled and treated. 87.0% of pts experienced treatment-emergent adverse events (TEAEs), and 29.9% were ≥ Grade 3. The TEAEs ≥15% were anemia (22.1%). No peripheral neuropathy was reported. In all efficacy evaluable pts of pharmacologically active dose groups (600 mg BID, 800 mg BID, and 1000 mg BID), an ORR of 24% (8/34) in the ICI-naïve pts was observed. In the 10 ICI-naïve pts with lung cancer (9 pre-treated and 1 treatment-naïve), the ORR was 40% (4/10). Notably, 3 of 6 (50%) EGFR-mutated and 1 of 2 (50%) KRAS-mutated pts achieved partial response (PR). All three responders with EGFR mutations had PD-L1 TPS ≥ 50% and progressed after at least one line of EGFR TKI therapies, including the 3rd generation. Other responses occurred in five mixed tumor types: MSI-H/dMMR gastric cancer, MSI-H/dMMR endometrial adenocarcinoma, vaginal squamous cell carcinoma, breast cancer (Lynch syndrome), and melanoma. The longest duration of response in the study was 17 months (endometrial adenocarcinoma) and the pt is still on treatment. T cell activation and a dose-dependent decrease in surface PD-L1 expression following ABSK043 treatment were observed in all BID dose groups.
About Glecirasib
Glecirasib (AST-24081) is a KRAS G12C inhibitor. A number of cinical trials are currenty ongoing in China, the United States and Europe forpatients with advanced soid tumors harboring KRAS G12C mutation. These include combination therapy trials with SHP2 inhibitor AST-24082in NSCLC and monotherapy trials in pancreatic cancer. Additionaly, the pancreatic cancer indication has received orphan drug designation inthe United States and breakthrough therapy designation in China. n May 2025, Glecirasib was approved for market launch by the ChinaNMPA.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number:4008803716
WeChat ID: 17801183037
Email:myimmnet@163.com
Post time: Aug-21-2025