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Text | Ye Fenghong
Recently, Bristol-Myers Squibb (BMS) announced that it has withdrawn romidepsin from the US market for the treatment of peripheral T-cell lymphoma (PTCL) indications
.
This decision is based on a confirmatory phase III clinical trial that did not meet the primary endpoint
Romidepsin is a histone deacetylase (histone deacetylase, HDAC) inhibitor.
It inhibits the activity of histone deacetylase and increases the acetylation level of histones to trigger chromatin remodeling.
The changes in gene expression of multiple signaling pathways that have occurred promote tumor cell growth arrest, differentiation and apoptosis
.
Developed by Clegene (Xinji) company
Subsequently, BMS carried out a confirmatory phase III clinical trial to evaluate romidepsin+CHOP (Ro-CHOP) and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in the first-line treatment of PTCL The efficacy in patients, but did not reach the primary efficacy endpoint of progression-free survival
.
Based on this result, BMS decided to withdraw the indication
Not only BMS, as early as 2015, Takeda Pharmaceutical also fell victim to the treatment of PTCL
.
In 2015, the Phase III clinical trial of Takeda's lymphoma drug alisertib ended in failure
PTCL treatment is tricky
PTCL treatment is trickyPTCL is a group of heterogeneous diseases of T lymphocytes or mature NK cells originating from the posterior thymus
.
It is estimated that the number of newly-increased patients with PTCL in China is approximately 1.
PTCL treatment drugs worth looking forward to
PTCL treatment drugs worth looking forward toDarinaparsin
Darinaparsin is an organic arsenic compound with anti-cancer activity, which has been developed to treat a variety of blood cancers and solid tumors
.
Its potential mechanism of action includes disturbing cell mitochondrial function, increasing the production of reactive oxygen species, and regulating intracellular signal transduction pathways
On June 30, Japan’s Solasia Pharma announced that it had submitted a New Drug Application (NDA) for its research drug darinaparsin to the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of relapsed/refractory PTCL
.
This is the first new drug application for darinaparsin in the world
DZD4205
DZD4205DZD4205 is a highly selective JAK1 inhibitor, developed by Dizhe Pharmaceutical
.
The JAK/STAT signal pathway is a cytokine-stimulated signal transduction pathway discovered in recent years.
DZD4205 shows good anti-tumor effects in patients with relapsed or refractory PTCL
.
The results of the phase I study showed that the effective rate of 150 mg/d DZD4205 treatment was 42%, and 21% of patients achieved complete remission after treatment
.
At present, Dizhe Medicine has launched an international multi-center phase II single-arm pivotal clinical trial for relapsed and refractory PTCL
.
As a subtype of T-cell lymphoma, PTCL has a higher incidence than other subtypes.
The standard treatment for PTCL has not been established.
Due to the poor prognosis and treatment difficulties of PTCL, there is a high degree of unmet medical needs
.
The two new drugs introduced above have unique mechanisms of action and are expected to become new treatment options for relapsed or refractory PTCL
.
I look forward to the smooth clinical trials of these two drugs and their early approval, which will benefit the majority of patients with malignant lymphoma
.
Reference source:
1.
DOI: 10.
3760/cma.
j.
cn115356-20210105-00004.
2.
Solasia Announces Submission of New Drug Application for Anti-cancer Drug DARINAPARSIN for Peripheral T-Cell Lymphoma in Japan.
Retrieved June 30, 2021, from https://
