Group 1 - The company announced the completion of patient enrollment for a Phase III clinical trial of its novel BCL2 inhibitor mesutoclax (ICP-248) in combination with BTK inhibitor ibrutinib for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [1][2][3] - Mesutoclax is a new oral, highly selective BCL2 inhibitor that restores apoptosis in tumor cells by selectively inhibiting BCL2 protein, which is crucial in the apoptosis pathway and is associated with various malignant hematological tumors [1][2][3] - The combination of mesutoclax and ibrutinib aims to provide deeper remission for first-line CLL/SLL patients and avoid the development of resistance mutations, presenting a significant potential treatment option [1][2][3] Group 2 - At the 67th American Society of Hematology (ASH) annual meeting in December 2025, multiple studies on mesutoclax were presented, showing good efficacy and safety in both treatment-naive and relapsed/refractory CLL/SLL patients, with an overall response rate (ORR) of 100% in the 125 mg mesutoclax dose group [2][4] - The rate of undetectable minimal residual disease (uMRD) in patients treated with mesutoclax and ibrutinib after 36 weeks was reported to be 65% [2][4] - In addition to first-line CLL/SLL treatment, mesutoclax is advancing towards clinical trials for treating mantle cell lymphoma after BTK inhibitor resistance and has received China's first breakthrough therapy designation [2][4] Group 3 - CLL/SLL is one of the most common types of leukemia, characterized as an indolent malignancy of B lymphocytes, with approximately 191,000 new cases and 61,000 deaths globally each year, and an increasing incidence trend in China [5]
ICP-248联合奥布替尼一线治疗慢淋/小淋的III期临床完成患者入组