China’s National Medical Products Administration has approved a Phase III trial of InnoCare Pharma’s ICP-248 (Mesutoclax) with orelabrutinib as a first-line therapy for chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL).
The regulatory body granted the approval through its Center for Drug Evaluation (CDE).
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The combination’s fixed-duration treatment is intended to achieve deeper remission for treatment-naïve subjects with no drug-resistant mutations, potentially leading to a clinical cure.
Findings from a Phase II trial of this therapy have shown a favourable safety profile and promising efficacy in treatment-naïve subjects.
The CDE’s approval of ICP-248 with orelabrutinib is expected to improve treatment options for these patients.
ICP-248 is an orally bioavailable B-cell lymphoma-2 (BCL2) selective inhibitor that promotes the normal process of apoptosis in cancer cells.
InnoCare Pharma CEO, chairwoman and co-founder Dr Jasmine Cui said: “ICP-248 is an important global asset in our haemato-oncology portfolio.
“We are rapidly advancing multiple clinical trials of ICP-248 globally, including the treatment of non-Hodgkin’s lymphoma, and acute myeloid leukaemia (AML).
“Our haemato-oncology pipeline is designed for strong synergy, especially with the combination of BTK and BCL2 inhibitors, which has the potential to deliver improved outcomes for patients.”
Orelabrutinib is a Bruton tyrosine kinase inhibitor that has received marketing approval in Singapore and China.
The drug has been approved for relapsed/refractory (r/r) CLL/SLL, r/r marginal zone lymphoma and r/r mantle cell lymphoma on China’s National Reimbursement Drug List.
InnoCare Pharma focuses on the development and commercialisation of drugs for cancer and autoimmune conditions with unmet medical needs.
The company is based in Beijing and has a presence in cities across China and the US.
In October last year, it announced that its Phase II study of ICP-488 for psoriasis had met its primary endpoint, with the drug showing an ‘excellent’ efficacy and safety profile.
