Study Result of Orelabrutinib in Patients with r/r MZL Published by American Journal of Hematology


Beijing, Sep. 13, 2023 - American Journal of Hematology recently published the study result of BTK (Bruton Tyrosine Kinase) inhibitor orelabrutinib in patients with relapsed or refractory (r/r) Marginal Zone Lymphoma (MZL), which investigated the efficacy and safety of orelabrutinib in r/r MZL. The journal concluded that orelabrutinib demonstrated high response rates with durable disease remission and was well tolerated in patients with relapsed or refractory MZL.

The majority of the enrolled patients had late-stage disease. After a median follow-up duration of 24.3 months, the overall response rate (ORR) assessed by an Independent Review Committee (IRC) ORR was 58.9%. Tumor reduction was observed in 92.2% of patients. The IRC-assessed median duration of response (DOR) was 34.3 months and median progression-free survival (PFS) was not reached. The 12-month PFS rate and overall survival (OS) rate was 82.8% and 91.0% respectively.

Due to the high target selectivity and fewer off-target effects, orelabrutinib demonstrated a good safety profile in the treatment of patients with r/r MZL.

In China, orelabrutinib was the first and only approved BTK inhibitor for the treatment of r/r MZL. Orelabrutinib has been also approved in China for the treatment of r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and r/r mantle cell lymphoma (MCL).

Marginal zone lymphoma (MZL) is a type of non-Hodgkin lymphoma (NHL) of indolent nature originating from B cells in the marginal zones of the spleen, lymphatic tissue, and lymph nodes. MZL accounts for 7%-8% of NHL cases and is the second most prevalent lymphoma among elderly adults. The annual incidence of MZL has increased globally.

The journal concluded that orelabrutinib produced a robust response and was well tolerated in r/r MZL patients. High response rates were consistent among patients with different MZL subtypes and those with negative disease prognostic factors at baseline. The results of this study support the use of orelabrutinib as an effective and tolerable oral treatment option for r/r MZL patients.

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.

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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. On Nov. 22, 2022, orelabrutinib was approved for the treatment of R/R MCL in Singapore. On April 20, 2023, orelabrutinib was approved for the treatment r/r MZL 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). Patient enrollment of Phase II registrational trial for R/R MCL was completed in the U.S. The Company expects to submit the NDA to the U.S. Food and Drug Administration (US FDA) in the middle of 2024.

In addition, the Company has achieved proof of concept (PoC) of orelabrutinib for the treatment of primary immune thrombocytopenia purpura (ITP) and the Phase III registrational trial is ongoing in China. Orelabrutinib’s global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE achieved proof of concept (PoC), and orelabrutinib’s phase II study for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) is ongoing 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.