Shanghai-based Abbisko Therapeutics Co., Ltd. (HKG: 2256) has revealed promising outcomes from a global, multi-center Phase I trial evaluating the safety, tolerability, pharmacokinetics (PK), and anti-tumor efficacy of its oral FGFR2/3 inhibitor, ABSK061, in treating solid tumors. These findings were presented at the European Society for Medical Oncology (ESMO) TAT 2024 annual meeting.
As of December 2023, 29 patients participated in the Phase Ia dose escalation study, with a median age of 54. The trial commenced with an initial dose of 5mg BID, encompassing 8 distinct dosing groups, with no dose-limiting toxicities (DLTs) reported during the escalation phase. The trial has advanced two cohorts, 75mg BID and 150mg QD, into the extended recommended dose (RDE) confirmation phase.
Among the 8 patients with solid tumors harboring FGFR2 fusions/amplifications or FGFR3 fusion mutations, three patients achieved a confirmed partial response (cPR), resulting in an objective response rate (ORR) of 37.5%. Additionally, three patients achieved stable disease (SD), while two experienced disease progression (PD), yielding a disease control rate (DCR) of 75%. ABSK061 demonstrated a favorable safety profile, with most adverse events being low-grade and reversible. Notably, the occurrence and severity of hyperphosphatemia and diarrhea were lower relative to pan FGFR inhibitors.- Flcube.com