Phase 3 CLL/SLL trial of ICP-248 plus orelabrutinib doses first patient
Combo treatment being tested for blood cancer type at 50 sites in China
The first patient has been dosed in a Phase 3 clinical trial testing ICP-248 (mesutoclax) in combination with orelabrutinib in adults with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), a type of blood cancer.
That’s according to an announcement from Innocare Pharma, the company developing both ICP-248 and orelabrutinib and sponsoring the trial.
The Phase 3 study (NCT06378138) is being conducted at 50 sites in China. It is actively recruiting people with CLL/SLL, ages 18 to 80, who have not received prior treatment for their cancer.
CLL/SLL is a common type of leukemia caused by the uncontrolled growth of B-cells, a type of immune cell. Both ICP-248 and orelabrutinib are designed to block the activity of proteins that are involved in the growth of B-cells.
“ICP-248 plays an important role in Innocare’s extensive hemato-oncology pipeline,” Jasmine Cui, the cofounder, chairwoman and CEO of Innocare, said in a company press release.
Phase 3 trial now recruiting adults with this leukemia type
Specifically, ICP-248 works by blocking the activity of the protein BCL2 (B-cell lymphoma-2), which helps cancer cells evade programmed cell death, known as apoptosis. Orelabrutinib, which is already approved to treat CLL/SLL in China and is sold by Innocare, works to block another protein called BTK — fully, Bruton’s tyrosine kinase — involved in B-cell receptor signaling.
The open-label trial, in which both researchers and participants know the exact treatment being given, is expected to enroll approximately 226 people with CLL/SLL. All participants will be treated with ICP-248 and orelabrutinib; both medications are taken by mouth once daily in 28-day treatment cycles.
The treatment of CLL/SLL has achieved significant breakthroughs in recent years, and [chemotherapy]-free regimens are gradually becoming the preferred approach.
The trial’s main goals are to evaluate the safety profile of the treatment combo and see how it affects patients’ pulse, blood pressure, and heart beat measurements.
“The treatment of CLL/SLL has achieved significant breakthroughs in recent years, and [chemotherapy]-free regimens are gradually becoming the preferred approach,” Cui said.
CLL/SLL is a typically slow-growing type of blood cancer characterized by the presence of immature white blood cells in the blood, bone marrow, and/or lymph nodes. Although CLL and SLL are essentially the same disease, in CLL the cancerous cells are primarily found in the blood and bone marrow, while in SLL, they are mainly located in the lymph nodes.
ICP-248 is also being evaluated in clinical trials of several other types of blood cancer. A Phase 1 trial (NCT06656494) is testing the therapy in people with acute myeloid leukemia (AML), including those who have not been treated before and those who have relapsed or failed to respond to other treatments. That study is recruiting adults with AML at two centers in China.
Another ongoing Phase 1 study (NCT05728658) is testing ICP-248 in people with several types of B-cell cancers, including CLL/SLL, non-Hodgkin’s lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, and lymphoplasmacytic lymphoma. That study is recruiting at 22 sites in China.
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