Clinical Study Result of Orelabrutinib in Patients with R/R MCL Published by Blood Advances

BEIJING–()–Blood Advances, part of leading hematology journal Blood, also a Journal of the American Society of Hematology, recently published the clinical study result of BTK (Bruton Tyrosine Kinase) inhibitor orelabrutinib in Relapsed or Refractory (r/r) Mantle Cell Lymphoma (MCL) patients. The journal concluded that orelabrutinib showed substantial efficacy and was well tolerated in patients with r/r MCL after long-term follow-up.

A total of 106 patients were enrolled in the study. After a median follow-up of 23.8 months, based on CT assessment, the overall response rate (ORR) was 81.1%, with 27.4% achieving complete response (CR) and 53.8% of partial response (PR), as assessed by the Independent Review Committee (IRC). The ORR and CR were 82.1% and 34.9% assessed by the investigator.

Patients achieved a rapid response. The median time to response (TTR) was 1.9 months. The median duration of response and progression-free survival were 22.9 and 22.0 months, respectively. The median overall survival (OS) was not reached and the rate of OS at 24 months was 74.3%. Orelabrutinib demonstrated a well-tolerated safety profile.

Professor Jun Zhu of Beijing Cancer Hospital said, “Orelabrutinib has shown potent activity in patients with r/r MCL and substantial improvement over early generation BTK inhibitor in response rates. In addition, orelabrutinib exhibited a favorable safety profile with a lower incidence of AE seen in the BTK inhibitor class, supporting a safe and highly effective treatment option for patients with r/r MCL.”

Mantle cell lymphoma (MCL) is a subtype of B-cell non-Hodgkin lymphoma that results from malignant transformation of B-lymphocytes in the mantle zone of lymph node follicles. MCL occurs most frequently in men at a median age of 60 years, and the majority of patients are in an advanced stage of disease when diagnosed. Despite high response rates after first-line hemoimmunotherapy, the majority of patients relapse and require subsequent treatment. There is no standard therapy for relapsed/refractory MCL, and the therapies approved by the Food and Drug Administration for this patient population are still limited, with low rates of CR, short durations of remission, and unfavorable safety and tolerability for older patients.

Blood Advances, a Journal of the American Society of Hematology, founded in 2016 and published online and open access, provides an international forum for the publication of original articles describing basic laboratory, translational, and clinical investigations in hematology and related sciences.

Note: In addition to background information, the content of this press release is derived from this published article. Full text can be found in

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.

In addition, orelabrutinib’s global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) 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.

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