Shenzhen Chipscreen Biosciences Co., Ltd. announced on April 30, 2024 that chidamide, a self-developed oral subtype-selective histone deacetylase (HDAC) inhibitor of the company, in combination with the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone), has been officially approved by the National Medical Products Administration (NMPA) of China for the treatment of previously untreated patients with diffuse large B-cell lymphoma (DLBCL) positive for MYC and BCL2 expression. To date, chidamide has obtained marketing approval for multiple indications worldwide. (See: Global Commercialization Status for details)
About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common type of lymphoma, with approximately 30,000 new cases diagnosed annually in China. Clinical diagnosis and treatment guidelines and consensuses both at home and abroad recommend the R-CHOP regimen as the standard first-line treatment for DLBCL. However, more than one-third of patients in the overall population fail to respond to first-line R-CHOP therapy or experience early relapse. Meanwhile, approximately 30% of DLBCL patients have concomitant overexpression of MYC and BCL2 proteins (referred to as double-expressor lymphoma, DEL), and their efficacy and prognosis with R-CHOP therapy are significantly poorer than those of non-double-expressor patients. Therefore, exploring and developing safe and effective novel combination therapeutic regimens based on the R-CHOP regimen remains an unmet significant clinical need in clinical practice.
About the Approval of the New Indication
The approval of this new indication is based on the DEB trial (NCT04231448), a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial. As the world’s first Phase III registrational clinical study for previously untreated MYC/BCL2 double-expressor DLBCL, the DEB trial was designed to evaluate the efficacy and safety of chidamide in combination with R-CHOP versus R-CHOP monotherapy in subjects with previously untreated MYC/BCL2 double-expressor DLBCL.
About Chidamide
Chidamide (generic name: Chidamide or Tucidinostat) is a novel molecular entity drug independently discovered by Chipscreen Biosciences, featuring a novel mechanism of action and belonging to the class of epigenetic modulators. It is China’s first approved original chemical new drug and the world’s first subtype-selective histone deacetylase (HDAC) inhibitor. Since its approval in China in December 2014 for the treatment of peripheral T-cell lymphoma (PTCL), chidamide has achieved remarkable commercial achievements worldwide and its research into new indications has been continuously advancing.
Global Commercialization Status
December 2014: Approved in China for the treatment of relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) patients who have received at least one prior systemic chemotherapy regimen.
November 2019: Approved in China for combination use with aromatase inhibitors in the treatment of postmenopausal patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), locally advanced or metastatic breast cancer that has relapsed or progressed following endocrine therapy.
June 2021: Approved in Japan as a monotherapy for the treatment of patients with relapsed or refractory (R/R) adult T-cell leukemia (ATL).
December 2021: Approved in Japan as a monotherapy for the treatment of patients with relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL).
March 2023: Approved in Taiwan, China for combination use with exemestane in the treatment of postmenopausal patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), locally advanced or metastatic breast cancer that has relapsed or progressed following endocrine therapy.
April 2024: Approved in China for combination use with the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) in the treatment of previously untreated patients with diffuse large B-cell lymphoma (DLBCL) positive for MYC and BCL2 expression.
