Novocinogen Obutinib in combination with Tafasitamab and lenalidomide was approved for Phase II in China

According to the wechat account of INNOCARE, InnoCare announced yesterday that Aubutinib ® in combination with tafasitamab (Minjuvi®) and lenalidomide has been approved for a single-arm, open-label, multi-cohort Phase II clinical trial in China. To evaluate its efficacy and safety in patients with relapsed/refractory non-Hodgkin lymphoma (NHL).

Tafasitamab, a humanized monoclonal antibody optimized for Fc domain targeting CD19, has been approved for the treatment of eligible DLBCL patients in the Boao Leccheng International Medical Tourism Pilot Zone, but tafasitamab has not yet been approved for any indication by the National Medical Products Administration in China. Thanks to Boao's policy, tafasitamab combined with lenalidomide made its first prescription in Boao Leicheng in July this year, and completed the first injection in China for a qualified DLBCL patient at Ruijin Hainan Hospital.

Aubutinib has been conditionally approved for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and relapsed/refractory mantle cell lymphoma (MCL) in China and for the treatment of relapsed/refractory mantle cell lymphoma in Singapore.

NHL is one of the most common cancers in China, including DLBCL, follicular lymphoma, etc. Data showed that there were 92,834 new NHL patients and 54,351 deaths in China in 2020 [1].

About aubutinib

Aubutinib is a Class 1 new drug developed by Novocentric. It is a highly selective new BTK inhibitor designed to treat hematologic tumors and autoimmune diseases.

Aubutinib was conditionally approved in China on 25 December 2020 for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, obutinib was included in national health insurance to benefit more patients. On 22 November 2022, obutinib was approved in Singapore for the treatment of relapsed/refractory mantle cell lymphoma.

Two new indications for the marketing of obutinib for relapsed/refractory warmulobulinemia (WM) and relapsed/refractory marginal zone lymphoma (MZL) have been accepted in China.

In addition, multi-center, multi-indication trials are being conducted in China and the United States using obutinib alone or in combination, such as first-line treatment for diffuse large B-cell lymphoma (DLBCL) MCD subtype.

Obutinib Designation was given by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL).

Global Phase II trials of obutinib in the treatment of multiple sclerosis (MS), as well as clinical trials in China for the treatment of systemic lupus erythematosus (SLE), primary immune thrombocytopenia (ITP), and optic neuromyelitis spectrum disease (NMOSD), are ongoing.

About tafasitamab

Tafasitamab is a humanized monoclonal antibody targeting CD19.

In 2010, MorphoSys acquired exclusive worldwide rights to develop and commercialize tafasitamab from Xencor.

Tafasitamab contains the XmAb® engineered Fc domain, which is unique to Xencor and thus significantly enhances antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cytophagocytosis (ADCP), which mediate B-cell tumor lysis through apoptosis and immune mechanisms.

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/refractory diffuse large B-cell lymphoma (DLBCL) (not specified), including DLBCL, which evolved from low malignant lymphoma. And patients who are not eligible for autologous stem cell transplantation. The indication received accelerated approval based on the overall response rate (ORR). Subsequent approval of this indication may depend on validation of clinical benefit in confirmatory trials.

In Europe, Minjuvi® (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, has been conditionally approved for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma who do not qualify for autologous stem cell transplantation.

tafasitamab is being studied as a treatment option for B-cell malignancies.

Monjuvi® and Minjuvi® are registered trademarks of MorphoSys, Inc. In the United States, tafasitamab is sold by Incyte and MorphoSys under the Monjuvi® brand; Incyte is marketed under the Minjuvi® brand in Europe, the United Kingdom and Canada. Under an agreement with MorphoSys, Incyte has the exclusive rights to commercialize tafasitamab outside the U.S. market. In August 2021, Northrob and Incyte entered into a collaboration and licensing agreement for the development and exclusive commercialization of tafasitamab in hematoma and solid tumor in Greater China.