On May 22, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported that the first patient has been dosed in the single-arm Phase I/II SWATCH Study (the "SWATCH" study), designed to evaluate the safety, tolerability and preliminary efficacy of XPOVIO (selinexor) in combination with the R2 regimen of lenalidomide plus rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and relapsed/refractory indolent non-Hodgkin lymphoma (R/R iHNL) (Press release, Antengene, MAY 22, 2022, View Source [SID1234614929]).
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"Antengene is dedicated to making selinexor widely available for patients in China. Formal launch of the product, inclusion in practice guidelines and conduct of additional studies in new indications and with new treatment regimens are all essential parts of our plan. We are very pleased to initiate the SWATCH study in China," said Dr. Kevin Lynch, Antengene’s Chief Medical Officer. "While there have been promising advances in patient care for hematologic malignancies, including R/R DLBCL and R/R iNHL, these cancers are among the top-10 cancer types worldwide and there is still a major need for improved treatments. We are hopeful that the results of the SWATCH study will pave the way to further improve the care of patient with R/R DLBCL and R/R iNHL, in China."
About the SWATCH Study
This open-label, multicenter, single-arm Phase 1/2 SWATCH study is comprised of a dose-escalation phase and a dose-expansion phase. It is designed to evaluate the safety, tolerability, and preliminary efficacy of selinexor in combination with lenalidomide and rituximab (R2) for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL).
The primary endpoints of the SWATCH study are the maximum-tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of the SR2 regimen determined by the dose-limiting toxicity (DLT) in patients with R/R DLBCL in the dose-escalation phase, as well as the safety and tolerability of the SR2 regimen determined by the key safety measures including adverse events (AEs) and serious AEs (SAEs). Secondary endpoints include the objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR) of the SR2 regimen as assessed per the Lugano 2014 criteria for the assessment of lymphoma (Cheson, 2014).
About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell Lymphoma (DLBCL) is an aggressive hematologic malignancy and the most common subtype of lymphoma in China1. It accounts for 60% of B-cell lymphoma in East Asia2.
While there have been promising medical advances, treatment options are still limited and there remains an enormous unmet medical need in patients with DLBCL. It is estimated that about half of patients with DLBCL will not achieve complete remission after receiving first-line treatment, and approximately 60% of patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) continue to lack effective treatment options.
About Indolent Non-Hodgkin Lymphoma
Indolent Non-Hodgkin Lymphoma (iNHL) is a hematological malignancy that accounts for 21% of all NHL incidences in China3.
Although the first-line treatment with rituximab in combination with various chemotherapies can deliver significant improvement to the overall survival (OS) of patients with iNHL, the majority of patients with R/R iNHL would still relapse and eventually become refractory, thus presenting an urgent need for novel drugs and combination therapies that can effectively improve treatment comes for patients with R/R iNHL.
About XPOVIO (selinexor)
XPOVIO is the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins and down-regulate the levels of multiple oncogenic proteins. Based on its novel mechanism of action, selinexor is being evaluated for use in multiple combination regimens in hematological and solid tumor cancers to improve treatment efficacy.
Antengene secured approval of selinexor in China in December 2021 for R/R MM. Antengene has also secured approval for XPOVIO in South Korea for use in R/R MM and R/R DLBCL, in Singapore for use in R/R MM and R/R DLBCL and in Australia for use in R/R MM. Antengene is conducting 10 clinical studies in mainland China (3 in collaboration with Karyopharm Therapeutics Inc. [Nasdaq:KPTI]) for relapsed/refractory hematological malignancies and advanced solid tumors.