On November 18, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the China National Medical Products Administration (NMPA) has approved a single-arm dose-finding Phase I/II study designed to evaluate the safety of selinexor (ATG-010) in combination with the R2 regimen of lenalidomide plus rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) and relapsed/refractory indolent non-Hodgkin lymphoma (rriNHL) (the "SWATCH" study) (Press release, Antengene, NOV 18, 2021, View Source [SID1234595817]).

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NHL is one of the most prevalent hematologic malignancies in China and in the world. In 2016, China reported 68,500 newly diagnosed NHL cases and 37,600 NHL-related deaths, which accounted for 14.9% and 15.7% of the NHL incidences and deaths reported globally. The age-standardized incidence rate, mortality rate, and prevalence of NHL in China are 4.29, 2.45, and 14.9 per 100,000, respectively, and both incidence and mortality rates have been on the rise with the increase in age. Although rituximab in combination with various chemotherapies can deliver significant improvement to the overall survival (OS) of patients with NHL, rriNHL represent an urgent unmet need. Further, while there have been promising advances in rrDLBCL treatment, effective treatment remains a challenge.

Ruijin Hospital of Shanghai Jiaotong University School of Medicine is the lead site in China for this 10-center study. The first segment of study will enroll patients with rrDLBCL in a dose-escalation phase, the second subsequent dose-expansion phase will enroll patients with either rrDLBCL (arm A) or rriNHL (arm B). Enrolled patients will be treated with selinexor in combination with the R2 regimen of lenalidomide plus rituximab (SR2). The objective of the Phase I/II study is to determine the treatment dose of the SR2 regimen, and evaluate the safety, tolerability, and preliminary efficacy of the combination regimen in patients with rrDLBCL or rriNHL who are not eligible for high-dose chemotherapy (HDC) or autologous stem cell transplantation (ASCT).

Prof. Weili Zhao, Chief Physician of the Hematology Department, Ruijin Hospital of Shanghai Jiaotong University School of Medicine, Vice Chair of the Chinese Society of Hematology, Vice Chair of the Lymphoma Alliance of the Chinese Society of Clinical Oncology, and the principal investigator of the study, commented: "With the current standard of care treatments, some patients with DLBCL or iNHL would still eventually relapse or become refractory, thus face a dismal prognosis. Therefore, we urgently need new therapies with novel mechanisms and fresh combination strategies that can bring this patient population greater survival benefits. This is the breakthrough we clinicians have been hoping for. Selinexor monotherapy has already been approved by the U.S. FDA for the treatment of rrDLBCL. In this Phase I/II study, we will evaluate the safety and tolerability of selinexor in combination with the R2 regimen in patients with rrDLBCL or rriNHL ineligible for DHC/ASCT. We hope the SR2 regimen will offer a more effective treatment option to patients with rrNHL."

Dr. Jay Mei, Founder, Chairman and CEO of Antengene, noted: "We are pleased that the NMPA has approved the single-arm dose-finding Phase I/II study designed to assess the safety and efficacy of selinexor plus the R2 regimen for the treatment of rrDLBCL and rriNHL. Selinexor (ATG-010) is Antengene’s first commercial-stage program. This study highlight’s Antengene’s complementary approach of developing new regimen and the Company’s dedication to select diseases, such as rriNHL, an indication for which selinexor was already approved by the U.S. FDA but still represents an urgent unmet clinical need in the APAC region. We look forward to advancing this study under the supervision of the NMPA, in an effort to develop a safe and effective new treatment regimen for patients with rrDLBCL and rriNHL."

About the SWATCH Study

This open-label, multicenter, single-arm Phase I/II study comprises a dose-escalation phase and a dose-expansion phase, and 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 (rrDLBCL) and relapsed/refractory indolent non-Hodgkin lymphoma (rriNHL). The primary endpoints of the study are the maximum-tolerated dose (MTD) and the recommended Phase II dose (RP2D) determined by the dose-limiting toxicity (DLT) observed in the dose-escalation phase as well as other key safety measures including the frequency of adverse events (AEs) and severe adverse events (SAEs). Secondary endpoints include 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).