Core Insights - InnoCare Pharma presented three studies on its BCL2 inhibitor, Mesutoclax (ICP-248), at the 67th Annual Meeting of the American Society of Hematology, showcasing its efficacy and safety in treating various hematologic malignancies [1][2]. Group 1: Efficacy in Relapsed/Refractory Mantle Cell Lymphoma (MCL) - Mesutoclax monotherapy demonstrated an overall response rate (ORR) of 87.5% and a complete response rate (CRR) of 46.9% in MCL patients, with an ORR of 84.0% and CRR of 36.0% in BTK inhibitor-refractory patients [3][4]. - The drug was well tolerated across all dose levels (50-150 mg), with no dose-limiting toxicities (DLTs) observed, indicating a promising safety profile [4]. Group 2: Efficacy in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) - In CLL/SLL patients, both treatment-naive and relapsed/refractory, the ORR was 100% for those receiving 125 mg of mesutoclax, with a 65% undetectable minimal residual disease (uMRD) rate at week 36 when combined with orelabrutinib [5][6]. - Mesutoclax exhibited a tolerable safety profile, with no DLTs reported up to 150 mg QD [6]. Group 3: Efficacy in Acute Myeloid Leukemia (AML) - The combination of mesutoclax and azacitidine (AZA) achieved a composite complete response (CR+CRi) rate of 92% in treatment-naive AML patients, with 82.6% achieving undetectable minimal residual disease (uMR) [7][8]. - The combination therapy was well tolerated, with no DLTs or tumor lysis syndrome (TLS) events reported, and a 90-day mortality rate of 0% [8]. Group 4: Ongoing Clinical Trials - InnoCare is conducting two registrational clinical trials: one for the combination of mesutoclax and orelabrutinib for treatment-naive CLL/SLL, and another for MCL patients refractory to BTK inhibitors [9]. - The clinical study of mesutoclax as a first-line treatment for AML has entered the dose expansion phase globally, and a study for myelodysplastic syndrome (MDS) is being launched [9].