On March 27, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the first patient has been dosed in the Phase III registrational trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 (Mesutoclax) in combination with BTK inhibitor orelabrutinib as a first-line therapy for patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in China (Press release, InnoCare Pharma, MAR 27, 2025, View Source [SID1234651548]).
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The fixed-duration treatment of ICP-248 in combination with orelabrutinib is expected to deliver deeper remissions for treatment-naïve CLL/SLL patients without drug-resistant mutations, bringing hope of clinical cure and representing a treatment option with great potential. Multiple clinical trials of ICP-248 for the treatment of acute myeloid leukemia (AML), non-Hodgkin’s lymphoma (NHL) and other indications are rapidly advancing in China and globally.
ICP-248 is a novel, orally bioavailable BCL2 selective inhibitor, developed as monotherapy or in combination with orelabrutinib for the treatment of CLL/SLL, MCL, AML, and other NHLs. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. ICP-248 exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells.
Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, "The treatment of CLL/SLL has achieved significant breakthroughs in recent years, and chemo-free regimens are gradually becoming the preferred approach. ICP-248 plays an important role in InnoCare’s extensive hemato-oncology pipeline. Together, ICP-248, orelabrutinib and tafasitamab form a robust product combination that reinforces InnoCare’s leadership in the treatment of hematologic malignancies. "
CLL/SLL, one of the most prevalent forms of leukemia, is an indolent malignancy of B lymphocytes. Globally, there are 191,000 newly diagnosed CLL cases each year, with 61,000 related deaths1. The incidence rate of CLL/SLL is on the rise in China.