InnoCare Pharma (HKEX: 09969; SSE: 688428) announced today that the Company has received approval from the Center for Drug Evaluation (CDE) to conduct a single-arm, open-label, multi-cohort phase II clinical trial evaluating the efficacy and safety of orelabrutinib in combination with tafasitamab + lenalidomide for the treatment of patients with relapsed or refractory Non-Hodgkin's lymphoma (NHL).
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare 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, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, is not approved by the National Medical Products Administration (NMPA) for any indication in China, except that tafasitamab in combination with lenalidomide has been approved by the Health Commission and Medical Products Administration of Hainan Province for the treatment of eligible DLBCL patients, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone. As part of this early access program, the first prescription of tafasitamab in combination with lenalidomide was filled in July at the Ruijin Hainan Hospital for an eligible DLBCL patient.
Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of relapsed or refractory DLBCL patients who are not eligible for autologous stem cell transplantation (ASCT).
Orelabrutinib received conditional approval from the NMPA in two indications: the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, and the treatment of patients with relapsed or refractory mantle cell lymphoma. Orelabrutinib was approved for the treatment of patients with relapsed or refractory MCL in Singapore.
NHL is one of the most common cancers in China, including DLBCL, follicular lymphoma, etc. Data shows that there were 92,834 new cases of NHL with 54,351 deaths in 2020 in China[1].
About Orelabrutinib
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
On Dec. 25, 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with r/r mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients. On Nov. 22, 2022, orelabrutinib was approved for the treatment of patients with relapsed or refractory MCL in Singapore.
The supplemental New Drug Application of orelabrutinib for the treatment of relapsed or refractory Marginal Zone Lymphoma (MZL) was accepted in China.
In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies, such as first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).
Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of relapsed or refractory MCL by U.S. Food and Drug Administration (FDA).
In addition, orelabrutinib is also being evaluated in global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of Systemic Lupus Erythematosus (SLE), Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.
About Tafasitamab
Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy.
In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.
Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dep...
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