InnoCare Pharma announced the approval of the Investigational New Drug (IND) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 in combination withuton's tyrosine kinase (BTK) inhibitor orelabrutinib as first-line therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in China. This multicenter, randomized-controlled, open-label clinical study is designed to evaluate the efficacy and safety of ICP-248 combined with orelabrutinIB versus immunochemotherapy in treatment-naive patients with CLL/SLL. ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which aims to treat hematologic malignancies as a monotherapy or in combination with other therapies.

BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies. ICP-248 has an anti-tumor effect by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death. The preliminary result has demonstrated a good efficacy and safety profile.

Orelabrutinib has been approved for marketing in China and Singapore, and all three approved indications related to lymphoma have been included in the National Reimbursement Drug List (NRDL) in China. In the treatment of relapsed/refractor CLL/SLL patients with orelabrut inib, the overall response rate and complete response rate reached 93.8% and 30% respectively, demonstrating an outstanding efficacy and safety profile.