RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (South Korea), Priority Review (United States)

Structure/Sequence

Molecular FormulaC17H11F6N7O

InChIKeyDEVSOMFAQLZNKR-RJRFIUFISA-N

CAS Registry1393477-72-9

211

Clinical Trials associated with Selinexor

NCT06822972

/ Not yet recruitingPhase 2IIT

A Phase II Safety and Efficacy Study of Selinexor in Combination With Bispecific Antibody in Patients With Relapsed/Refractory Multiple Myeloma

The primary objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy.
The investigators will enroll 27 patients with RRMM who are receiving commercial bispecific antibody therapy. Patients will be on treatment for 12 months or until disease progression, and will be followed for 24 months. Study assessments include completing a drug diary, having a safety check in call, and have history, clinical assessments, and labs taken.
Twenty-seven patients will provide 80% power in a one-sample chi square test for a proportion assuming that the rate of negative MRD at 10-5 at 12 months post bispecific antibody therapy is 25% in historical control and 50% in the SEL+bispecific antibody experimental treatment group, under a one-sided 5% significance level.

Start Date01 May 2025

Sponsor / Collaborator

Duke University

NCT06853678

/ RecruitingNot ApplicableIIT

Selinexor Combined With Nab-paclitaxel and Adebrelimab as Second-line Treatment for ES-SCLC：A Prospective, Single-center, Single-arm Clinical Study

At present, the first-line standard treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) is immunotherapy combined with chemotherapy. For patients who relapse within 6 months after first-line chemotherapy, conventionally recommended chemotherapy drugs include topotecan, irinotecan, gemcitabine, paclitaxel or vinorelbine, etc., but due to limited benefits to patients, patients are also recommended to participate in relevant clinical studies. New treatment methods are constantly being explored in second-line treatment, including fluzoparib combined with adebelimumab. The current status of second-line treatment is still worrying.
Selinexor is a class of nuclear export selective inhibitors (SINEs) for the export protein receptor XPO1. PO1 promotes the transport of mRNA and cargo proteins, including tumor suppressor proteins (TSPs), hormone receptors (GRs), and immune response regulators. Selinexor covalently binds to the XPO1 protein, blocking the export of TSPs and GRs and accumulating them in the nucleus, preventing the translation of oncoprotein mRNA, stopping the cell cycle process, and initiating apoptosis. Multiple in vitro and in vivo studies have verified that selinexor combined with chemotherapy/radiotherapy/targeted therapy exhibits significant anti-tumor activity.
This study plans to use selinexor combined with adebrelimab and albumin-paclitaxel as a second-line treatment for ES-SCLC to explore the efficacy and safety of this regimen.

Start Date28 Feb 2025

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

NCT06813079

/ Not yet recruitingPhase 2IIT

ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial

The purpose of this study is to see if using Patient Derived Organoids (PDO) to choose a drug for the treatment of pancreatic cancer individually for each patient is useful. The study will look at the number of participants who have a response to their assigned drug.

Start Date17 Feb 2025

Sponsor / Collaborator

University Health Network

100 Clinical Results associated with Selinexor

100 Translational Medicine associated with Selinexor

100 Patents (Medical) associated with Selinexor

718

Literatures (Medical) associated with Selinexor

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Prognostic and functional role of the nuclear export receptor 1 (XPO1) in gastrointestinal cancers: a potential novel target?

Review

Author: Pichler, Renate ; Ormanns, Steffen ; Günther, Michael ; Neureiter, Daniel ; Amann, Arno ; Sokolova, Viktorija ; Gruber, Rebecca ; Pammer, Lorenz M ; Seeber, Andreas ; Klieser, Eckhard ; Kocher, Florian

In the last decades the survival of metastatic gastrointestinal (GI) cancer patients could have been significantly extended due to the introduction of targeted- and immunotherapy. However, only the minority of patients will experience long-lasting survival. Hence, novel therapeutics are clearly necessary for GI cancer patients. Molecular high-throughput profiling techniques have revealed potential novel targetable molecular alterations, emphasizing the necessity for tailored therapeutic approaches. Nuclear export proteins, particularly Exportin-1 (XPO1), have emerged as promising targets in cancer therapy due to their crucial role in cellular homeostasis and regulation of key cellular functions. Dysregulation of XPO1-mediated nuclear export leads to the functional loss of tumor suppressors and pro-apoptotic factors, facilitating cancer progression. Selinexor, a XPO1 inhibitor, has shown promising activity in preclinical and clinical studies, particularly in hematological malignancies. However, its efficacy in GI cancers remains underexplored. This review aims to elucidate the functional and pathophysiological role of XPO1 in GI cancers. Despite the potential of XPO1 inhibitors in suppressing cell proliferation and inducing apoptosis, comprehensive molecular landscape data and validation of selective inhibitors in GI cancers are lacking. Targeting XPO1 presents a significant therapeutic potential for the treatment of GI cancer patients. Further research is necessary to fully elucidate the molecular landscape according to XPO1 expression in GI tumors and to validate the efficacy of selective XPO1 inhibitors. These efforts are expected to contribute to the development of more effective and personalized therapeutic strategies for GI cancer patients.

01 Jun 2025·JOURNAL OF MOLECULAR STRUCTURE

Design, synthesis and pharmacological evaluation of triazolopyrimidines derivatives as novel agonists for benzodiazepine receptor

Author: Li, Mengjiao ; Yi, Shijia ; Liu, Zheng ; Yan, Hui ; Hu, Lina ; Lei, Kang ; Wang, Xuekun ; Wang, Shiben

In this paper, two series of triazolopyrimidines derivatives were designed, synthesized, and all the target compounds were structurally confirmed using ¹H NMR, ¹³C NMR and HRMS methods.Pharmacol. experiments were carried out using maximal electroshock (MES), s.c. pentylenetetrazole (scPTZ) and rotating rod (ROT) models for activity and neurotoxicity screening, and potential compounds were screened out for further determination of ED₅₀, TD₅₀ and in vitro binding experimentsFinally, compound 5,7-Bis(pentyloxy)-[1,2,4]triazolo[1,5-a]pyrimidine (6b) with best activity and lowest toxicity was obtained.The pharmacol. results showed that the ED₅₀ of compound 6b was MES = 11.3 mg/kg, PTZ = 9.5 mg/kg, which was superior to that of the carbamazepine (MES = 6.3 mg/kg) and ethosuximide (PTZ = 3.6 mg/kg).The IC₅₀ of compound 6b binding affinity toward the GABA_A receptor was 0.15 μM, and the GABA content experiments showed that compound 6b significantly increased the GABA content in the rat brain.In elevated plus maze (EPM) assay, compound 6b possessed anxiolytic effects.In silico studies, most of the target compounds have suitable physicochem. and pharmacokinetic data with the possibility of drug-forming properties, mol. docking results showed that compound 6b could generate more interactions with the amino acid residues of diazepam active site of GABA_A receptor.

01 Apr 2025·Recent Patents on Anti-Cancer Drug Discovery

Selinexor as a Therapeutic Target: Advances in Non-small Cell and Small Cell Lung Cancer Treatment Strategies

Article

Author: Zhang, Wenqi ; Liu, Qingyi ; Gao, Maogang ; Zheng, Bosheng ; Wang, Shize ; Liu, Guangjie ; Xie, Shaonan ; Han, Yaqing ; Liu, Yanjie

Selinexor treats lung cancer, particularly non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). This review summarizes the prevalence and types of lung cancer and emphasizes the challenges associated with current treatments like resistance and limited effectiveness. Selinexor is a selective inhibitor of nuclear export (SINE) that has emerged as a potential therapy that targets the nuclear export of tumor suppressor proteins. The mechanisms of selinexor, its potential in combination therapies, and challenges like side effects and drug resistance are explained in this review. Key findings highlight the effectiveness of selinexor in preclinical studies, particularly against KRAS-mutant NSCLC and in combination with chemotherapy for SCLC. The review concludes with a discussion of future directions and underscores the potential of selinexor to improve the treatment strategies for lung cancer.

277

News (Medical) associated with Selinexor

21 Mar 2025

·www.prnewswire.com

Antengene Announces 2024 Full-Year Financial Results, Proprietary Programs Advancing to Pivotal Trials with Accelerating Multi-market Revenue Ramp Up

SHANGHAI and HONG KONG, March 21, 2025 /PRNewswire/ -- Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) today announced its full-year results for the period ending December 31, 2024, along with several significant milestones achieved in recent months. Dr. Jay Mei, Antengene's Founder, Chairman, and CEO, stated, "To Antengene, 2024 was indeed an extraordinary year in which we achieved remarkable progress on multiple fronts, including clinical development, R&D and commercialization. ATG-022, our Claudin 18.2 antibody-drug conjugate that is being evaluated in a Phase II study in Australia and China, has shown highly differentiated clinical potential, demonstrating efficacy not only in gastric cancer patients with mid to high Claudin 18.2 expressions, but also unprecedented clinical benefit for patients with low or ultra-low expressions. Furthermore, AnTenGagerTM TCE 2.0, Antengene's proprietary platform incorporating steric hindrance-masking technology, has shown impressive capabilities, with its preclinical data demonstrating a significantly more favorable safety profile than those of the first-generation TCE platforms, and potential clinical efficacy covering solid tumors, hematologic malignancies and autoimmune diseases. We will seek various forms of collaboration with global partners around this technology platform in order to fully unlock its potential value. ATG-201, a CD19 x CD3 TCE 2.0 developed on the AnTenGageTM TCE 2.0, is poised to enter clinical development in the second half of 2025. In addition to the rapid progress in R&D and clinical development, we also achieved impressive results in commercialization. Our first approved product, XPOVIO®, has clearly picked up momentum in its global expansion while having its second indication approved and included in the NRDL in China. Also during the reporting period, XPOVIO® was included for reimbursement in South Korea and Taiwan China, and approved for commercialization in Malaysia, Thailand, and Indonesia. To date, XPOVIO® has been approved in 10 APAC markets and included for reimbursement coverage in 5 of those markets. Currently, the company has a cash reserve of RMB 900 million which is sufficient to fund its continued operations over the next three years even without future revenue income. We look forward to updating you all on our progress in 2025, with the next one being the latest results on the AnTenGageTM TCE 2.0, scheduled for release at this year's AACR Annual Meeting." 1. Claudin 18.2 ADC Demonstrates Significant Clinical Value, with Multiple Programs Advancing Steadily at the Clinical Stage ATG-022（Claudin 18.2 Antibody-Drug Conjugate, ADC） Unique Therapeutic Potential: ATG-022 is a highly differentiated ADC demonstrated efficacy across the broadest range of CLDN18.2 expression levels. Clinical data show that ATG-022 not only effectively targets gastric cancer patients with high CLDN18.2 expression but is also effective in tumors with low and ultra-low CLDN18.2 expression. Additionally, ATG-022 has shown better safety profile without accumulative systemic toxicities, and much fewer dose-limiting toxicities and lower high grade adverse effects compared to other CLDN 18.2 ADCs in similar clinical development stages. It also has received two Orphan Drug Designations (ODDs) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric and pancreatic cancer. Ongoing CLINCH study: As of November 22, 2024, among 21 gastric cancer patients in the dose expansion phase with CLDN18.2 expression at IHC 2+ ≥ 20% achieved an Objective Response Rate (ORR) of 42.9% and a Disease Control Rate (DCR) of 95.2% (9 patients had Partial Responses [PR], 8 of which were confirmed; 11 patients had Stable Disease [SD]). Additionally, 10 patients with CLDN18.2 expression at IHC 2+ < 20% treated at efficacious doses of 1.8 – 2.4 mg/kg had an ORR of 30.0% (1 patient achieved a Complete Response [CR], 2 achieved PR, and all confirmed CR/PR cases had CLDN18.2 expression IHC 2+ < 5%), with a DCR of 50.0%. The patient who achieved a CR has demonstrated sustained remission and has been in the study for over 14 months as of the data cut-off date. The Phase II CLINCH study is progressing smoothly in China and Australia. Other Clinical Stage Programs ATG-037 (CD73 Small Molecule Inhibitor): ATG-037 has demonstrated pre-clinically the ability to overcome the "hook effect" that can limit efficacy and is commonly seen in anti-CD73 antibodies. Antengene entered into a global clinical collaboration with MSD and is currently evaluating this molecule in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with anti-PD-1 resistant melanoma and non-small cell lung cancer (NSCLC). At the 2024 European Society of Medical Oncology (ESMO) Congress, clinical data from the ongoing Phase I STAMINA dose-escalation study were presented in a Mini Oral session. As of the latest data cut-off date on November 27, 2024, among the 26 evaluable patients with prior anti-PD-1 resistance who received ATG-037 in combination with pembrolizumab, 9 had NSCLC and 11 had melanoma. Among these patients, the ORR is 35% and DCR is 85%. These data indicate that ATG-037 has the potential to reverse anti-PD-1 resistance during the dose-escalation phase. Currently, the Phase II STAMINA dose optimization and expansion study is progressing smoothly in China and Australia. ATG-031 (Anti-CD24 Monoclonal Antibody): ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter clinical trials for cancer in the U.S. ATG-031 works by blocking CD24-Siglec10 and enhancing macrophage-mediated phagocytosis of cancer cells. Key study sites of ATG-031 include four renowned cancer centers in the United States: MD Anderson Cancer Center at the University of Texas, University of California, San Francisco (UCSF), University of Colorado, and Yale Cancer Center. The Phase I PERFORM study is progressing smoothly in the U.S. 2. The Exciting Proprietary AnTenGagerTM TCE 2.0 with Steric Hindrance-masking Technology Next-Generation TCE Platform: The AnTenGagerTM TCE 2.0 is Antengene's proprietary "2+1" TCE platform which features a steric hindrance-masking technology designed to enable disease-associated antigen (DAA)-dependent T-cell activation. This approach is intended to achieve potent therapeutic activity while reducing the risk of cytokine release syndrome (CRS). Compared to first-generation TCE platforms, AnTenGagerTM TCE 2.0 offers better safety and has broader applicability in different indications such as in solid tumors, hematological malignancies, and autoimmune diseases. Additionally, AnTenGagerTM TCE 2.0 has a longer half-life, which allows for reduced dosing frequency and improved clinical convenience. The company will continue to advance the development of AnTenGagerTM TCEs. Global Collaborations: Antengene will seek a range of collaborations with its global partners for the AnTenGageTM TCE 2.0, through platform access, co-development, and out-licensing, in order to enable the accelerated development of an ecosystem around TCE therapeutics and maximize the value of the technology platform. ATG-201 (CD19 x CD3 TCE 2.0): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed using the AnTenGagerTM TCE 2.0 for the treatment of B cell related autoimmune diseases. In preclinical studies, ATG-201 demonstrated superior B-cell depletion compared to benchmark molecules, along with reduced cytokine release. The company expects ATG-201 to enter clinical development in the second half of 2025. Antengene will continue to advance other preclinical programs, including ATG-042 (a selective PRMT5 inhibiting targeting MTAP-null tumors), ATG-106 (CDH6 x CD3 TCE 2.0) for ovarian and renal cancer, and ATG-110 (LY6G6D x CD3 TCE 2.0) for microsatellite stable (MSS) colorectal cancer. 3. Accelerating Global Expansion: Covering 10 APAC Markets Mainland of China: In July 2024, XPOVIO® received approval for a second indication in Mainland China, providing a new treatment option for Chinese DLBCL patients. In November 2024, this indication was included in the National Reimbursement Drug List (NRDL). As of now, both approved indications of XPOVIO® in China are covered under national insurance, further expanding patient access. South Korea: In June 2024, XPOVIO® received national reimbursement approval in Korea, effective from July 1, 2024. In October 2024, XPOVIO® was approved for an additional third indication in Korea. The company is actively working to expand reimbursement coverage for more indications in Korea. Taiwan Market: In February 2025, XPOVIO® received national reimbursement approval in Taiwan market, making it the fifth APAC market to secure reimbursement coverage after mainland of China, South Korea, Australia, and Singapore. ASEAN Markets: Since August 2024, XPOVIO® has been successively approved in Malaysia, Thailand, and Indonesia, marking significant progress in Antengene's commercialization strategy across the APAC region. XPOVIO® is now approved in 10 countries and regions across APAC for multiple indications. 4. Strong Cash Reserves to Support Continuous Growth As of December 31, 2024, the company held RMB 900 million in cash and bank balances, which is sufficient to fund the company's continuous growth and operations over the next three years even without additional financing. To learn more about the annual financial results of 2024, please see the full announcement on the "Investor Relations" section of the website. About Antengene Antengene Corporation Limited (" Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of " Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted new drug applications (NDAs) in 11 Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2024, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical ResultDrug ApprovalPhase 2Orphan Drug

20 Mar 2025

·www.globenewswire.com

Menarini Group Announces Collaboration with VisualDx to Aid in Identifying People Who May Have Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

BPDCN is an aggressive hematologic malignancy with a historically poor prognosisVisualDx is a clinical decision support system used by more than 2,300 hospitals, clinics, and medical schools around the world VisualDx’s system seeks to enhance identification of people who may have BPDCN, leveraging actual images of BPDCN skin lesions and artificial intelligence/machine learning (AI/ML) technologies incorporated into the VisualDx platform FLORENCE, Italy and NEW YORK, March 20, 2025 (GLOBE NEWSWIRE) -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, today announced that they are collaborating with VisualDx to enhance identification of people who may have BPDCN. This is an example of innovative companies working together to bring artificial intelligence/machine learning (AI/ML) tools to help identify BPDCN as a possible early differential diagnosis. The project includes leveraging actual images of BPDCN skin lesions and AI/ML technologies incorporated into the VisualDx platform. The AI model is now live within VisualDx. VisualDx is a physician-led company committed to improving medical decision-making, medical education and research. The VisualDx tool is a clinical decision support system used by more than 2,300 hospitals, clinics, and medical schools around the world. The software includes a comprehensive database of clinical images, submitted through partnerships with learning institutions and others, and vetted by clinicians, to assist healthcare professionals to identify skin concerns across all skin types. Through the AI image search, clinicians can better understand different skin conditions with the goal of supporting patients to get more accurate diagnoses throughout their care journeys. BPDCN is an aggressive orphan hematologic malignancy with a historically poor prognosis (approximately 8.7 to 14 months post diagnosis1) that typically presents skin lesions and can also involve the bone marrow, blood, central nervous system, lymph nodes and viscera. Dermatologists may be the first to recognize the signs of BPDCN and biopsy suspicious lesions. Pathologists can then test for BPDCN by testing for certain biomarkers which are highly expressed on BPDCN cells. Tagraxofusp-erzs is the only approved treatment for patients with BPDCN, and the first and only approved CD123-targeted therapy, in the United States, Europe and other global regions. "BPDCN is a rare and clinically aggressive hematologic malignancy, often presenting with cutaneous lesions. Due to its aggressive nature and the immature cell involvement, the prognosis can be poor if not treated promptly,” said Marina Konopleva, MD, Phd, Professor, Molecular Pharmacology, Director, Leukemia Program and Co-Director, Blood Cancer Institute, at Montefiore Einstein. “Early diagnosis plays a critical role in improving patient outcomes, and emerging AI/ML technologies may offer valuable support in the differential diagnosis and early identification of BPDCN." “BPDCN often first presents as a skin lesion and usually has a poor prognosis. There is a dire need for early diagnosis so that patients may access appropriate treatment options,” said Elcin Barker Ergun, CEO of the Menarini Group. “We are delighted to collaborate with VisualDx to provide healthcare teams with a tool using the latest artificial intelligence/machine learning (AI/ML) technology to help interpret challenging skin lesions.” VisualDx does not store any images uploaded by clinicians taking a picture of their patients’ skin exams. This helps maintain the patient’s privacy. About BPDCNBPDCN, formerly blastic NK-cell lymphoma, is an aggressive, orphan hematologic malignancy, often with cutaneous manifestations, with historically poor outcomes. BPDCN typically presents skin lesions and may also involve bone marrow, blood, central nervous system, lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. The World Health Organization (WHO) termed this disease “BPDCN” in 2008; previous names included blastic NK cell lymphoma and CD4+/CD56+ hematodermic neoplasm. About ELZONRIS® (Tagraxofusp-erzs)U.S. Indication: ELZONRIS is a prescription medicine used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients 2 years and older. Full prescribing information for the U.S. can be found at www.elzonris.com IMPORTANT SAFETY INFORMATION, ELZONRIS®Boxed WARNING: CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended. Warnings and Precautions Capillary Leak Syndrome Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with ELZONRIS. In patients receiving ELZONRIS in clinical trials, the overall incidence of CLS was 53% (65/122), including Grade 1 or 2 in 43% (52/122) of patients, Grade 3 in 7% (8/122) of patients, Grade 4 in 1% (1/122) of patients, and four fatalities (3%). The median time to onset was 4 days (range - 1 to 46 days), and all but 5 patients experienced an event in Cycle 1. Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g/dL. During treatment with ELZONRIS, monitor serum albumin levels prior to the initiation of each dose of ELZONRIS and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonary edema, hypotension or hemodynamic instability. Hypersensitivity Reactions ELZONRIS can cause severe hypersensitivity reactions. In patients receiving ELZONRIS in clinical trials, hypersensitivity reactions were reported in 43% (53/122) of patients treated with ELZONRIS and were Grade ≥ 3 in 7% (9/122). Manifestations of hypersensitivity reported in ≥ 5% of patients include rash, pruritus, and stomatitis. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur. Hepatotoxicity Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients receiving ELZONRIS in clinical trials, elevations in ALT occurred in 79% (96/122) and elevations in AST occurred in 76% (93/122). Grade 3 ALT elevations were reported in 26% (32/122) of patients. Grade 3 AST elevations were reported in 30% (36/122) and Grade 4 AST elevations were reported in 3% (4/122) of patients. Elevated liver enzymes occurred in the majority of patients in Cycle 1 and were reversible following dose interruption. Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Withhold ELZONRIS temporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved. Adverse Reactions Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST. Please see full Prescribing Information, including Boxed WARNING.To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About The Menarini GroupThe Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit menarini.com. About Stemline Therapeutics Inc.Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers. About VisualDxVisualDx is a company dedicated to improving medical decisions through augmented thinking and timely visualization. It is committed to reducing disparities in medicine and believes technology can bridge gaps in knowledge to bring about more equitable care. VisualDx has become the standard professional resource at more than 2,300 hospitals, clinics and medical schools worldwide by combining problem oriented clinical search with the world's best curated medical image library, plus medical knowledge from experts and sophisticated machine learning algorithms to help with differential diagnosis, variation, treatment, and patient communication. Learn more at www.visualdx.com Media ContactsThe Menarini GroupValeria Speroni CardiEmail: pressoffice@menarini.com Stemline Therapeutics, Inc.Cheya PopeEmail: media@menarinistemline.com 1 Pagano L, et al Haematological. 2013;98 (2): 239-246 and Pemmaraju N Curr Hematol Malig Rep. 2017; 12(6): 510-512

Drug ApprovalClinical Result

05 Mar 2025

·www.prnewswire.com

XPOVIO® (selinexor) Approved for Commercialization in Indonesia, Further Expanding Antengene's Commercial Presence in APAC

- XPOVIO® is the first and only approved XPO1 inhibitor in Indonesia. - From the second half of 2024 to now, XPOVIO® was successively approved in Thailand, Malaysia and Indonesia, significantly expanding Antengene's commercial presence in APAC. To date, XPOVIO® has been approved for multiple indications in ten markets across the APAC region. - XPOVIO® has been approved for health insurance coverage in the mainland of China, Taiwan market, Australia, Singapore and South Korea. SHANGHAI and HONG KONG, March 5, 2025 /PRNewswire/ -- 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, today announced that the Indonesia National Agency of Drug and Food Control (BPOM) has approved a New Drug Application (NDA) for XPOVIO® (selinexor) for three indications: (1) In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy;(2) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory MM (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), at least two immunomodulatory agents (IMiDs), and an anti‐CD38 monoclonal antibody; and (3) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy who are not eligible for haematopoietic cell transplant. With a novel mechanism of action, XPOVIO® is the world's first approved orally-available, selective XPO1 inhibitor, which has already been approved in ten countries and regions in APAC, and has been included in the national insurance schemes in five of these markets (the mainland of China, Taiwan market, Australia, Singapore and South Korea). The ASEAN region, with its steady economic growth and a population exceeding 600 million, has become a market of significant potential for global biomedical development. The accelerating aging population in ASEAN has increased the overall disease burden on patients and local communities, leading to a growing demand for novel therapeutics. Currently, Antengene is actively expanding its presence into APAC markets in efforts to introduce more innovative medicines to the ASEAN region in the future, improving the level of healthcare in these regions and benefiting more patients in need. While bringing XPOVIO® to more APAC markets, Antengene is also striving to expand the indications of XPOVIO®. Leveraging the drug's novel mechanism of action, Antengene is currently developing multiple combination regimens of XPOVIO® for the treatment of various indications including myelofibrosis (MF) and endometrial cancer. About XPOVIO® (selinexor) XPOVIO® is the world's first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses. By blocking the nuclear export protein XPO1, XPOVIO® can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO® delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO® is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of XPOVIO® in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]). About Antengene Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalNDA

100 Deals associated with Selinexor

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KEGG	Wiki	ATC	Drug Bank
D11222	Selinexor	L01XX66	DB11942

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Follicular Lymphoma	Indonesia	Antengene Corp. Ltd.	05 Mar 2025
Refractory Multiple Myeloma	Macao	Antengene Corp. Ltd.	06 Dec 2023
Relapse multiple myeloma	Macao	Antengene Corp. Ltd.	06 Dec 2023
Diffuse large B-cell lymphoma recurrent	Israel	Karyopharm Therapeutics, Inc.	04 Feb 2021
Diffuse large B-cell lymphoma refractory	Israel	Karyopharm Therapeutics, Inc.	04 Feb 2021
Diffuse Large B-Cell Lymphoma	United States	Karyopharm Therapeutics, Inc.	22 Jun 2020
Multiple Myeloma	United States	Karyopharm Therapeutics, Inc.	03 Jul 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory acute myeloid leukemia	Phase 3	China	Antengene Corp. Ltd.	29 Jan 2023
Relapsing acute myeloid leukemia	Phase 3	China	Antengene Corp. Ltd.	29 Jan 2023
Endometrial Carcinoma	Phase 3	China	Antengene Corp. Ltd.	27 Oct 2021
Endometrial Carcinoma	Phase 3	China	Karyopharm Therapeutics, Inc.	27 Oct 2021
Myelofibrosis	Phase 3	United States	Karyopharm Therapeutics, Inc.	11 Mar 2021
Myelofibrosis	Phase 3	Belgium	Karyopharm Therapeutics, Inc.	11 Mar 2021
Myelofibrosis	Phase 3	Bulgaria	Karyopharm Therapeutics, Inc.	11 Mar 2021
Myelofibrosis	Phase 3	Canada	Karyopharm Therapeutics, Inc.	11 Mar 2021
Myelofibrosis	Phase 3	Czechia	Karyopharm Therapeutics, Inc.	11 Mar 2021
Myelofibrosis	Phase 3	Denmark	Karyopharm Therapeutics, Inc.	11 Mar 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03992339 (SEARCH study \| SEARCH, CTgov)	Phase 2	Diffuse Large B-Cell Lymphoma	60	ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle	xnmygfeylr = hmiygwdcuv sakaindzfn (phngorybbf, hmbrovzvwn - gandpeuutb) View more	-	07 Feb 2025
NCT02419495 (Pubmed \| Cancer Med) Manual	Phase 1	Advanced Renal Cell Carcinoma	29	Selinexor + Nivolumab	hbvzivsvll(yxhtcvcvsm) = including 10% with hyponatremia, 7% with neutropenia, and 7% with thromboembolic events. nidbclawzw (abazwphlxv )	Positive	01 Feb 2025
				Selinexor + NivolumabNivolumab + Ipilimumab
NCT02419495 (Pubmed \| J Immunother Precis Oncol)	Phase 1	Uveal Melanoma	10	Selinexor 60 mg PO twice weekly + Pembrolizumab	hqmlqfmits(agnhuxsjzd) = yhcqpsjxbp tlgmuezyqu (ituafqakic, 4 - notreached) View more	Positive	01 Feb 2025
				Selinexor 60 mg PO once weekly + Nivolumab and Ipilimumab	hqmlqfmits(agnhuxsjzd) = myvnxmebgh tlgmuezyqu (ituafqakic, 7 - notreached) View more
NCT04421378 (XPORT-GBM-029 \| CTNI-18, CTgov)	Phase 1/2	Glioblastoma Multiforme \| Recurrent Glioblastoma	74	Selinexor (Arms A+B+C+D+E: Selinexor)	jswfvgrvxm = tlfhhhjqrw xnnjbgvdwa (njtrugjiwn, bibhkmxaam - lfqcybefrh)	-	16 Dec 2024
				Selinexor (Arm A: Selinexor + Radiation Therapy)	ripocdzrth = almprvtelj vyujvjhwvr (dcpcucvnxt, prhaqwnhhp - tnzywmmdal) View more
NCT04939142 (BENCH, ASH2024) Manual	Phase 3	Multiple Myeloma	154	Selinexor + Bortezomib + Dexamethasone	cjsdiuxicg(qyqdbbinfm) = zmlhypmnnz dhyxkdxgdz (kixetmudev ) View more	Positive	09 Dec 2024
				Bortezomib + Dexamethasone	cjsdiuxicg(qyqdbbinfm) = meyqzsimpo dhyxkdxgdz (kixetmudev ) View more
NCT04425070 (TOUCH, ASH2024) Manual	Phase 1/2	Extranodal NK-T-Cell Lymphoma	17	Selinexor + Tislelizumab	vkwkomzvvh(xhvcaodgqn) = wihshjmeyi msftludrid (nbfotzpdtx ) View more	Positive	09 Dec 2024
				Selinexor + Tislelizumab (CPIs exposed pts)	vkwkomzvvh(xhvcaodgqn) = kbjyqzfdst msftludrid (nbfotzpdtx ) View more
ASH2024 Manual	Phase 2	Myelofibrosis	40	Selinexor + Ruxolitinib	aizwvmazeg(mrnlssvafl) = pwwxfsvsgf gccnvgrnlq (dtbhsywyxw ) View more	Positive	09 Dec 2024
ASH2024	Not Applicable	Multiple Myeloma	-	Selinexor/dexamethasone/pomalidomide	qvzqllpwft(xabvuhgeyj) = Toxicity and tolerability were consistent with previous selinexor trials and generally manageable, with 11% of patients discontinuing treatment early due to adverse events. gtukjmkhvc (ntpxjeajdj )	-	08 Dec 2024
ASH2024	Not Applicable	Multiple Myeloma	-	Selinexor 60 mg QW	jdjwqbzuuf(sbatbnrscl) = Entire cohort: 54.3%/33.3%, SPd60: 65.0%/25.0%, SPd40: 31.3%/18.8% wnitleuhor (dujbzmnzdi ) View more	-	07 Dec 2024
				Selinexor 40 mg QW
ASH2024	Not Applicable	Multiple Myeloma	-	Selinexor 40 mg QW + Lenalidomide 25mg + Dexamethasone 20mg	nyqcbtdxgc(jmhecmievk) = Grade 3 events included: Anxiety (N=1) clfutlsdmn (vryoeybjrf ) View more	-	07 Dec 2024

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