China’s Center for Drug Evaluation (CDE) has granted approval for InnoCare Pharma to conduct a Phase II clinical trial of orelabrutinib along with tafasitamab + lenalidomide to treat Non-Hodgkin’s lymphoma (NHL).
The multi-cohort, single-arm, open-label clinical trial has been designed to assess the safety and efficacy of the combination to treat relapsed or refractory NHL patients.
Orelabrutinib developed the highly selective BTK inhibitor orelabrutinib to treat cancers and autoimmune diseases.
The China National Medical Products Administration (NMPA) granted conditional approval for orelabrutinib to treat relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) and r/r mantle cell lymphoma (MCL) patients.
The BTK inhibitor is currently being evaluated in multi-centre, multi-indication clinical trials as monotherapy or in combination therapies, as first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL) in China and the US.
Additionally, it is being assessed to treat Multiple Sclerosis (MS) in global phase II studies, and for the treatment of Systemic Lupus Erythematosus (SLE), Neuromyelitis Optica Spectrum Disorder (NMOSD), and Primary Immune Thrombocytopenia (ITP) in China.
InnoCare co-founder, chairwoman and CEO Dr Jasmine Cui said: “We are dedicated to building a leading hematology-oncology franchise with orelabrutinib and tafasitamab + lenalidomide as backbone therapies.
“NHL remains an area of strong unmet medical need in China, and we will accelerate this clinical trial along with the registrational trial of tafasitamab in combination with lenalidomide for relapsed or refractory diffuse large B-Cell lymphoma (DLBCL) in China.”
Tafasitamab is a humanised Fc-modified cytolytic CD19-targeting immunotherapy.
The combination of tafasitamab and lenalidomide is approved by the Health Commission and Medical Products Administration of Hainan Province to treat eligible DLBCL patients, under the early access programme in Boao Lecheng International Medical Tourism Pilot Zone.