Antengene announces approval of phase II study of Selinexor for the treatment of myelofibrosis in China
SHANGHAI and HONG KONG, August 24, 2021 / PRNewswire / – Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to the discovery, development and commercialization of world-leading and / or world-leading therapeutics in hematology and cancer. oncology, today announced that from China The National Medical Products Administration has approved a Phase II study of selinexor (XPOVIO®) for the treatment of patients with myelofibrosis (MF).
MF is a narrow clonal bone neoplasia that can emerge as primary MF (PMF), polycythemia vera (PV), or essential thrombocythemia (ET). The disease is mainly characterized by bone marrow fibrosis, extramedullary hematopoiesis, anemia, splenomegaly, constitutional symptoms and possible progression to leukemia which would reduce patient survival. Allogeneic hematopoietic stem cell transplantation (allo-GCSH) is currently the only curative treatment for MF. However, such treatment is generally associated with a high rate of treatment-related complications and death. According to the National Comprehensive Cancer Network (NCCN®) Guidelines for the treatment of MF, patients with intermediate risk 2 or high risk MF not eligible for allo-HSCT and with a platelet count 50 × 109/ L should be treated with JAK inhibitors ruxolitinib or fedratinib (2020 NCCN® Guidelines). Due to the poor prognosis of patients who have failed or developed resistance to these targeted therapies, MF continues to represent an urgent unmet medical need.
This global, multicenter, randomized, open-label phase II study will be conducted in 15 centers across China, including the main trial center, First Affiliated Hospital Soochow University, and enrolled approximately 20 patients in total. The study is designed to assess the safety and efficacy of selinexor versus physician’s choice (PC) in patients with FM who have received at least six months of treatment with a JAK1 / 2 inhibitor. Enrolled patients will be randomized 1: 1 into one of two treatment arms, to receive either selinexor or PC therapy. The primary endpoint of the study is the proportion of patients with reduction in spleen volume ≥ 35% from baseline (SVR35), as assessed by the Independent Radiographic Review Committee (IRC ).
Teacher. Depei Wu, Head of the Department of Hematology at First Affiliated Hospital Soochow University, and Principal Investigator of the study, noted, “MF is a relatively rare form of proliferative neoplasm in narrow bone that has long lacked effective treatment options before the emergence of targeted therapies. Allo-HSCT is currently the only curative treatment for patients with MF, but not all patients MF are eligible or tolerant to treatment Although ruxolitinib has already been approved in China for the treatment of MF, patients who have failed or developed resistance to therapy still have very limited treatment options. This global, randomized, open-label, phase II study is designed to evaluate the safety and efficacy of selinexor versus physician choice (PC) in patients with FM who have received at least six months of treatment with a JAK1 / 2 inhibitor. We strongly hope that this study will provide further evidence to support the exploration of effective treatments for MF and ultimately provide a new treatment option for patients with MF in China. “
Dr. Jay mei, Founder, Chairman and CEO of Antengene, commented: “The approval by the NMPA of this clinical trial of selinexor in patients with myelofibrosis marks another important step in our efforts to develop selinexor in a wide range of diseases, and a big step towards it. expansion of the potential indications for this drug candidate. We are confident that selinexor will demonstrate clinical utility in the treatment of MF as we progress through this clinical development program. China. “
About Selinexor (XPOVIO®)
Selinexor is a first-order oral selective nuclear export inhibitor (SINE) discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), Selinexor is currently being developed by Antengene, which holds the exclusive rights to develop and market certain Asia Pacific markets, including Greater China, Korea, Australia, New Zealand and ASEAN countries, and has already obtained NDA approval in South Korea through a priority review process.
In July 2019, the United States Food and Drug Administration (FDA) has approved selinexor in combination with low-dose dexamethasone for the treatment of relapsed / refractory multiple myeloma (MMRR) and in june 2020 approved selinexor as monotherapy for the treatment of relapsed / refractory diffuse large B-cell lymphoma (LDGCB RR). In december 2020, selinexor also received FDA approval as a combination treatment for multiple myeloma after at least one prior treatment. In February 2021, selinexor has been approved by the Israeli Ministry of Health for the treatment of patients with RRMM or RR DLBCL and in March 2021, the European Commission (EC) has granted conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of adult patients with RRMM.
Selinexor is to date the first and only oral SINE compound approved by the FDA and the first drug approved for the treatment of MM and DLBCL. Selinexor is also being evaluated in several other mid and later phase clinical trials in multiple indications of solid tumors, including liposarcoma and endometrial cancer. In november 2020, at the Connective Tissue Oncology Society (CTOS 2020) Annual Meeting 2020, Antengene partner Karyopharm presented the positive results of the randomized, double-blind, placebo-controlled, crossover SEAL trial evaluating a single agent, oral selinexor versus corresponding placebo in patients with liposarcoma. Karyopharm also announced that the ongoing SIENDO Phase III trial of selinexor in endometrial cancer patients has passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) has recommended that the test proceeds as planned without any modification. The first results of the SIENDO trial are expected in the second half of 2021.
Antengene is currently conducting several clinical trials with selinexor for the treatment of MM, DLBCL, endometrial cancer, and peripheral T and NK / T lymphomas, and five of these trials are at an advanced stage (Phase II / III). .
Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading R&D-driven biopharmaceutical company focused on innovative drugs for oncology and other life-threatening diseases. Antengene aims to provide the most advanced anticancer drugs to patients in the Asia-Pacific region and around the world. Since its creation in 2017, Antengene obtained 16 Investigational New Drug Approvals (INDs), submitted 6 New Drug Applications (NDAs) in several Asia Pacific markets, with the NDA for selinexor in South Korea already approved through a priority review process. Leveraging partnerships as well as in-house drug discovery, Antengene has built a large and expanding pipeline of 13 clinical and preclinical assets, comprising 8 global rights assets and 5 assets with rights to Asia Pacific markets including Greater China Region. Driven by his vision of “Treating patients across borders“, Antengene is committed to meeting significant unmet medical needs by discovering, developing, manufacturing and marketing first-class / best-in-class therapeutic products.
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SOURCE Antengene Corporation Limited