BEIJING
InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that 10 studies on the BTK inhibitor orelabrutinib developed by InnoCare were selected at the 64th American Society of Hematology (ASH) Annual Meeting on December 10-13, 2022, which will be held online and offline in New Orleans, United States.
Oral Presentation
Title: Orelabrutinib, Rituximab, and High-Dose Methotrexate (HD-MTX) in Newly Diagnosed Primary Central Nervous System Lymphoma (PCNSL): A Retrospective Analysis on Efficacy, Safety, and Biomarker
Abstract Number: 558
Session Name: 627. Aggressive Lymphomas: Clinical and Epidemiological: Real World Evidence for Management of CNS Lymphoma and Post CAR T-cell relapse for aggressive B-cell NHL
Presentation Time: 1:15 PM, Dec. 11, 2022 (Sunday)
First Author: Shihua Zhao
Corresponding Author: Wenrong Huang
Poster Presentation 1
Title: A Multicenter, Single-Arm, Prospective Phase Ⅱ Study of Orelabrutinib Combined with High-Dose Methotrexate and Rituximab Sequential Autologous Hematopoietic Stem Cell Transplantation in Newly-Diagnosed Primary Central Nervous System Lymphoma
Abstract Number: 1624
Session Name: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Presentation Time: 5:30-7:30 PM, Dec. 10, 2022 (Saturday)
First Author: Ji Ma
Poster Presentation 2
Title: Efficacy and Safety of Lenalidomide, Anti-PD-1 Antibody Combined with Orelabrutinib or Rituximab in the Treatment of Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Abstract Number: 1636
Session Name: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Presentation Time: 5:30-7:30 PM, Dec. 10, 2022 (Saturday)
First Author: Yuqing Miao
Corresponding Author: Hao Xu
Poster Presentation 3
Title: Preliminary Result of Phase 1 Trial of Orelabrutinib in Combination with Rituximab, Methotrexate, and Dexamethasone in Patients with Newly Diagnosed Primary CNS Lymphoma Implementing Bayesian Design for Dose-Seeking
Abstract Number: 2951
Session Name: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster II
Presentation Time: 6:00-8:00 PM, Dec. 11, 2022 (Sunday)
First Author: Yan Yuan
Corresponding Author: Tong Chen
Poster Presentation 4
Title: Thiotepa, Orelabrutinib, and Methotrexate Combined with or without the Rituximab Regimens in the Treatment of Patients with Central Nervous System Lymphoma
Abstract Number: 4291
Session Name: 627. Aggressive Lymphomas: Clinical and Epidemiological: Poster Ⅲ
Presentation Time: 6:00-8:00 PM, Dec. 12, 2022 (Monday)
First Author: Ruolan Zeng
Corresponding Author: Hui Zhou
Poster Presentation 5
Title: Orelabrutinib in Combination with Rituximab and chemotherapy for Newly Diagnosed Aggressive B-Cell Lymphoma: A Multicenter, Single-Arm, Prospective Study
Abstract Number: 4295
Session Name: 627. Aggressive Lymphomas: Clinical and Epidemiological: Poster Ⅲ
Presentation Time: 6:00-8:00 PM, Dec. 12, 2022 (Monday)
First Author: Xiangxiang Zhou
Corresponding Author: Xin Wang
Online Abstract 1
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP Versus Placebo Plus R-CHOP in Treatment-Naive Patients with Mcd Subtype Diffuse Large B-Cell Lymphoma
Abstract Number: 5525
First Author: Weili Zhao
Corresponding Author: Pengpeng Xu
Online Abstract 2
Title: A Phase I/II Study of Orelabrutinib Combined with Anti-Programmed Cell Death Protein-1 Antibody and Fotemustine for Patients with Newly Diagnosed Primary Central Nervous System Lymphoma (PCNSL)
Abstract Number: 5508
First Author: Xudong Zhang
Corresponding Author: Mingzhi Zhang
Online Abstract 3
Title: Preliminary Outcomes of Orelabrutinib Plus RCHOP in Treatment-Naïve Patients with Double-Expression Diffuse Large B Cell Lymphoma
Abstract Number: 5521
First Author: Yang Yang
Corresponding Author: Zhen Cai
Online Abstract 4
Title: Orelabrutinib and Venetoclax Show Synergistic Lethality in Double-Hit Lymphoma By Interfering with the Crosstalk between the PI3K/AKT and p38/MAPK Signaling
Abstract Number: 5248
First Author: Mengya Zhong
Corresponding Author: Bing Xu
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.
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chunhua.lu@innocarepharma.com
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