InnoCare Gets Approval for Phase III Study of ICP-248 and Orelabrutinib for First-Line CLL/SLL Therapy in China
InnoCare Pharma, a prominent biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, has made a significant announcement regarding the approval of its Phase III clinical trial for ICP-248 (Mesutoclax), a B-cell lymphoma-2 (BCL2) inhibitor. The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) granted approval for the registrational Phase III study of ICP-248 in combination with orelabrutinib as a first-line therapy for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients in China. This development marks an important milestone for the company, as it brings a new potential treatment option to the forefront of cancer therapy, especially for patients with CLL and SLL.
ICP-248 (Mesutoclax) is a highly selective, orally bioavailable inhibitor that targets BCL2, a regulatory protein involved in the apoptosis (cell death) process. The abnormal expression of BCL2 is commonly linked to the development of various hematologic malignancies, including CLL/SLL. ICP-248 works by inhibiting BCL2, restoring the normal apoptosis pathway, and thereby promoting the death of cancer cells. The combination of ICP-248 with orelabrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, is designed to offer enhanced therapeutic efficacy for treatment-naïve CLL/SLL patients, especially those without drug-resistant mutations. The goal is to achieve deeper remission in these patients, potentially offering a clinical cure and a treatment option with substantial long-term benefits.
The combination therapy of ICP-248 and orelabrutinib has already shown promising results in clinical trials. In a Phase II study, the therapy demonstrated significant efficacy in treatment-naïve CLL/SLL patients, with a favorable safety profile. These positive results suggest that the treatment could be an important step forward in the management of CLL/SLL, particularly for patients who have not received prior treatment. If the Phase III trial continues to show favorable outcomes, it could lead to market approval, providing a new and effective treatment option for patients battling this challenging condition.
Dr. Jasmine Cui, the co-founder, chairwoman, and CEO of InnoCare, highlighted the importance of ICP-248 as a global asset within the company’s hemato-oncology portfolio. She emphasized that InnoCare is rapidly advancing multiple clinical trials of ICP-248 globally, including studies focused on non-Hodgkin’s lymphoma and acute myeloid leukemia (AML). Dr. Cui also pointed out the strong synergy in the company’s hemato-oncology pipeline, particularly with the combination of BTK inhibitors like orelabrutinib and BCL2 inhibitors like ICP-248. This combination therapy has the potential to deliver improved outcomes for patients, especially those with hematologic malignancies like CLL/SLL.
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are both indolent (slow-growing) malignancies that primarily affect B lymphocytes, a type of white blood cell involved in immune response. CLL is the most common type of leukemia in adults, while SLL is closely related to CLL and often presents with similar clinical features. Together, CLL and SLL represent a significant global health burden, with approximately 191,000 new cases of CLL diagnosed each year worldwide, leading to an estimated 61,000 deaths annually. In China, the incidence of CLL/SLL has been on the rise, underscoring the growing need for effective treatment options.
The current treatment landscape for CLL/SLL includes a variety of therapies, such as chemotherapy, monoclonal antibodies, and targeted therapies like Bruton’s tyrosine kinase (BTK) inhibitors. However, many patients experience relapses or resistance to these therapies, highlighting the need for new treatment options. The approval of the Phase III trial for ICP-248 in combination with orelabrutinib offers a promising alternative, particularly for patients who have not yet been treated and do not carry drug-resistant mutations.
Orelabrutinib, the BTK inhibitor that is being studied in combination with ICP-248, has already received approval for marketing in China and Singapore. It has been included in the National Reimbursement Drug List (NRDL) in China for several indications, including relapsed/refractory (r/r) CLL/SLL, r/r mantle cell lymphoma (MCL), and r/r marginal zone lymphoma (MZL). Orelabrutinib’s approval and inclusion in the NRDL make it a key player in the treatment of various B-cell malignancies in these regions.
The combination of ICP-248 and orelabrutinib is expected to offer several potential advantages over existing treatments. For one, the dual mechanism of action — targeting both BCL2 and BTK — may lead to more robust and sustained responses in patients. Additionally, the oral bioavailability of both ICP-248 and orelabrutinib makes the treatment regimen more convenient for patients compared to traditional intravenous therapies. By providing a more accessible and potentially more effective treatment option, this combination therapy could greatly improve the quality of life for CLL/SLL patients.
InnoCare’s commitment to advancing its hemato-oncology pipeline is evident in the ongoing development of ICP-248 in combination with orelabrutinib and other targeted therapies. The company is also investigating the use of ICP-248 in combination with other agents in various hematologic cancers, including non-Hodgkin’s lymphoma and AML. The success of these trials could further solidify InnoCare’s position as a leader in the development of novel cancer therapies.
Looking ahead, InnoCare will continue to focus on the clinical development of ICP-248 and its other promising assets. With a growing portfolio of treatments for hematologic cancers and autoimmune diseases, the company is well-positioned to make a meaningful impact in the fight against these diseases. The approval of the Phase III trial for ICP-248, along with its positive results in earlier trials, marks an exciting milestone in InnoCare’s journey and offers hope for patients with CLL/SLL who have limited treatment options.
As the Phase III clinical trial progresses, InnoCare is committed to providing further updates on the study’s outcomes and the potential regulatory approvals for ICP-248 and orelabrutinib. If the trial results are successful, it could pave the way for the market approval of this combination therapy, providing a new weapon in the arsenal against CLL/SLL and potentially other hematologic malignancies.
In summary, the approval of the registrational Phase III study for ICP-248 in combination with orelabrutinib as a first-line therapy for CLL/SLL patients in China represents a significant advancement in cancer treatment. With its novel mechanism of action and promising clinical trial results, this combination therapy has the potential to provide deeper remission and better outcomes for patients with CLL/SLL. InnoCare’s ongoing commitment to advancing its hemato-oncology pipeline and its focus on innovative therapies could lead to further breakthroughs in the treatment of hematologic cancers, offering new hope to patients around the world.
About InnoCare
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
