On May 25, 2022 InnoCare Pharma (HKEX: 09969) reported that it has received approval to conduct a single-arm, open-label, multicenter phase II clinical trial evaluating the safety and efficacy of tafasitamab in combination with lenalidomide by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT) (Press release, InnoCare Pharma, MAY 25, 2022, View Source [SID1234615046]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, which 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 adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Tafasitimab is not approved by the NMPA for any indication.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "We will make every effort to accelerate the clinical development of tafasitamab in combination with lenalidomide to help address the unmet needs of DLBCL patients in China."

Tafasitamab (Monjuvi) is co-commercialized by Incyte and MorphoSys in the United States and by Incyte under the brand name Minjuvi in the EU. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globallyi. In China, DLBCL accounts for 45.8% of all NHLsi.

About Tafasitamab

Tafasitamab is a humanized monoclonal antibody targeting CD19.

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-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Full approval for this indication may be contingent upon results in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Tafasitamab is not approved for use in China except for in the Boao Lecheng International Medical Tourism Pilot Zone through an early access program.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S. and marketed by Incyte under the brand name Minjuvi in the EU. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

XmAb is a registered trademark of Xencor, Inc.