Orelabrutinib demonstrated a well-tolerated safety profile. Most adverse events (AEs) were Grade 1 or 2. Similar to the observation in other studies with orelabrutinib, atrial fibrillation/flutter was not observed in this study.

Professor Jianyong Li, Department of Hematology, Pukou CLL Center, The First Affiliated Hospital of Nanjing Medical University, said, “This study confirmed that orelabrutinib was efficacious in treating R/R CLL/SLL patients, with durable responses and an improved safety profile. As a selective BTK inhibitor with favorable pharmacokinetic and pharmacodynamic properties, orelabrutinib provides an alternative therapeutic option for patients with R/R CLL/SLL.

Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), one of the most common types of leukemia, is an indolent malignancy of B lymphocytes, mainly affecting the elderly population. Although CLL/SLL is indolent, some patients will progress over time. There are 191,000 newly diagnosed CLL cases and 61,000 deaths every year globally. Long-term treatment for CLL/SLL is very important, since early discontinuation will compromise the efficacy. A new generation of BTK inhibitors with higher selectivity and improved safety profiles is in urgent need.

The American Journal of Hematology is an academic journal focusing on hematology, which was founded in 1976 and published monthly by WILEY publisher. The journal has been included in SCIE and SCI databases, with an impact factor of 13.268 in 2022.

Note: In addition to background information, the content of this press release is derived from this published article. Full text can be found in https://onlinelibrary.wiley.com/doi/10.1002/ajh.26826.

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 chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.

The supplemental New Drug Applications of orelabrutinib for the treatment of R/R WM and R/R Marginal Zone Lymphoma were 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 r/r 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 SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.

Source:- Businesswire