Antengene Corporation Limited, a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that the Chinese Society of Clinical Oncology (CSCO), the most prominent organization in oncology in China, added multiple selinexor regimens to its 2021 Diagnosis and Treatment Guidelines (CSCO Guidelines) for treatment of multiple myeloma and lymphoma. Three selinexor regimens recommended by the Guideline for the Diagnosis and Treatment of myeloma include: (i) selinexor plus dexamethasone; and (ii) selinexor plus dexamethasone plus bortezomib; and (iii) selinexor plus dexamethasone plus pomalidomide for the treatment of relapsed myeloma. Meanwhile, the guideline has also recommended selinexor for the treatment of relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). As the gold standard guiding Chinese oncologists in their clinical practice, the CSCO Guidelines is the one of the most recognized guidelines in China.
Multiple myeloma (MM) is a malignancy caused by the dysregulated proliferation of plasma cells. It is the second most common hematologic malignancy in many countries. MM is hard to treat and prone to relapse. Despite availability of a number of treatments for relapsed patients, most still succumb to their disease and new treatment options are needed. As a growing number of novel therapies enter into clinical treatment, it has become a challenge to choose the most effective treatment option. Diffuse large B-cell lymphoma (DLBCL) is an aggressive hematologic malignancy that about half of patients with DLBCL will not reach complete remission after receiving first-line treatments, and approximately 60% of patients with rrDLBCL lack effective treatment options.
Selinexor is the world's first approved oral selective inhibitor of nuclear export (SINE), representing a novel mechanism of action (MoA) in cancer therapy. Selinexor induces the apoptosis of cancer cells through the targeted inhibition of the nuclear export protein XPO1 that leads to the nuclear storage and activation of tumor-suppressor proteins and other growth-regulating (GR) proteins, and by down-regulating the levels of various oncogenic proteins.
Myeloma
For the treatment of relapsed myeloma
Level 1 recommendation for selinexor plus dexamethasone (based on Class 1 evidence)
Level 2 recommendation for selinexor plus dexamethasone plus bortezomib (based on Class 2 evidence)
Level 2 recommendation for selinexor plus dexamethasone plus pomalidomide (based on Class 2 evidence)
The STORM trial is a multicenter, single-arm, open-label trial designed to evaluate the efficacy of selinexor plus dexamethasone (Xd) in patients with relapsed or refractory multiple myeloma (rrMM) that had previous exposure to multiple lines of therapy. Results from this trial showed an objective response rate (ORR) of 26% in rrMM with the Xd combination regimen in patients with rrMM who have received a median of seven previous regimens.
The STOMP trial is a multicenter, open-label, randomized Phase I/II trial designed to evaluate the safety and efficacy of various Xd combination regimens in patients with rrMM. Results from this trial showed a median progression-free survival (mPFS) of 12.2 months in patients that received the combination of selinexor, pomalidomide, and dexamethasone, and an ORR of 60% in patients that received selinexor at recommended Phase II dose (RP2D). In proteasome inhibitor (PI) nonrefractory patients, the combination of selinexor, bortezomib, and dexamethasone has demonstrated an ORR of 84%.
Lymphoma
The guideline has also recommended selinexor for the treatment of lymphoma. In the comments on the treatment of patients with rrDLBCL, the guideline recommended second-line therapies or personalized treatments that ...
(All Rights Reserved)