InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, today announced the latest clinical data of its Bruton Tyrosine Kinase (BTK) inhibitor orelabrutinib at the 17th International Conference on Malignant Lymphoma (ICML).

Oral Presentation

Orelabrutinib, a New-Generation Bruton Tyrosine Kinase Inhibitor, Demonstrates Safety and Efficacy in Relapsed/Refractory Marginal Zone Lymphoma (MZL) (Abstract Number: Nr.283)

Professor Jun Zhu of Beijing Cancer Hospital said, “Orelabrutinib demonstrated high response rates with durable disease remission and was well tolerated in Chinese patients with r/r MZL.”

The primary endpoint was overall response rate (ORR) assessed by an Independent Review Committee (IRC) based on the Lugano 2014 classification.

Among the enrolled Chinese patients, the majority had late-stage diseases, with the stage IV accounting for 75.9%. After a median follow-up of 22.3 months, the IRC-assessed ORR was 57.8%, and median duration of response (DoR) and median progression-free survival (PFS) was 34.3 months and 36.0 months respectively. The 12-month PFS rate was 84.3% and the rate of overall survival (OS) was 91.5% at 12 months.

Treatment was well tolerated with most treatment-related adverse events (TRAE) being grade 1 or 2.

Online Publication

Orelabrutinib-lenalidomide-rituximab in patients with untreated mantle cell lymphoma (MCL): a prospective, multicenter, single-arm phase 2 POLARIS study in China (Abstract Number: Nr.600)

This study aimed to explore the efficacy and safety of orelabrutinib plus lenalidomide and rituximab in untreated MCL. The preliminary data indicated that the orelabrutinib plus lenalidomide and rituximab exerted synergistic antitumor activity, with a good safety profile in the treatment of MCL.

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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