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Last update 01 Jul 2026

Selinexor

Last update 01 Jul 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

CRM1-nuclear-export-inhibitor, NEXPOVIO, Selinexor

+ [13]

Target

ACADS x XPO1

Action

inhibitors

Mechanism

ACADS inhibitors(acyl-CoA dehydrogenase short chain inhibitors), XPO1 inhibitors(Exportin-1 protein inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [9]

Active Indication

Follicular LymphomaRefractory Multiple MyelomaRelapse multiple myeloma+ [68]

Inactive Indication

Acute Myeloid Leukemia with FLT3/ITD MutationAcute Promyelocytic LeukemiaAdenocarcinoma of prostate+ [67]

Originator Organization

Karyopharm Therapeutics, Inc.

Active Organization

Antengene Corp. Ltd.

Karyopharm Therapeutics, Inc.

National Cancer Institute

+ [13]

Inactive Organization

The University of Texas MD Anderson Cancer Center

Takeda Pharmaceutical Co., Ltd.

Millennium Pharmaceuticals, Inc.

+ [1]

License Organization

FORUSTherapeutics, Inc.

Antengene Corporation Co., Ltd.

Foundation Medicine, Inc.

+ [12]

Drug Highest PhaseApproved

First Approval Date

United States (03 Jul 2019),

Multiple Myeloma

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

Structure/Sequence

Molecular FormulaC17H11F6N7O

InChIKeyDEVSOMFAQLZNKR-RJRFIUFISA-N

CAS Registry1393477-72-9

230

Clinical Trials associated with Selinexor

NCT07632170

/ Not yet recruitingNot ApplicableIIT

The Efficacy and Safety of Selinisole Combined With Azacitidine and Venetoclax in the Treatment of Newly Diagnosed High-risk Myeloid Tumors With TP53 Mutations: A Multicenter, Single-arm, Prospective Study

Patients with high-risk myeloid tumors accompanied by TP53 mutations have a poor survival prognosis, and there are still many unmet treatment needs. The current treatment regimens have many limitations. Selinisol, as a novel export protein inhibitor, has good anti-tumor activity. The current preclinical and preliminary clinical research results abroad suggest its effectiveness and safety. This study aims to evaluate the efficacy and safety of AZA combined with selinisole (with or without venetoclax) in the treatment of patients with high-risk myeloid tumors with TP53 mutations through a multicenter, prospective clinical study.

Start Date01 Nov 2026

Sponsor / Collaborator

Peking Union Medical College Hospital

NCT07626021

/ Not yet recruitingPhase 2IIT

An Open-Label, Single-Arm Phase II Study of Selinexor Monotherapy for Cytoreduction in Patients With BCR::ABL1-Negative Myeloproliferative Neoplasms

Myeloproliferative neoplasms are chronic blood cancers in which the bone marrow produces too many blood cells. Patients with Philadelphia chromosome-negative myeloproliferative neoplasms, including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may need treatment to reduce high blood cell counts, relieve disease-related symptoms, and lower the risk of complications. However, currently available cytoreductive treatments may be ineffective, poorly tolerated, or inconvenient for some patients.
Selinexor is an oral selective inhibitor of nuclear export that has shown antitumor activity in several hematologic malignancies. This study will evaluate the effectiveness and safety of selinexor used alone as cytoreductive treatment in patients with Philadelphia chromosome-negative myeloproliferative neoplasms who have an indication for cytoreductive therapy.
This is a prospective, single-arm, open-label phase II study conducted at a single center. Eligible participants will receive oral selinexor, with dose adjustments based on tolerability and blood cell counts. Participants will be followed for treatment response, symptom improvement, and side effects for up to 6 months. The results of this study may help determine whether selinexor could provide a potential treatment option for patients with Philadelphia chromosome-negative myeloproliferative neoplasms who have limited cytoreductive therapy choices.

Start Date01 Jul 2026

Sponsor / Collaborator

Zhongshan Hospital Xiamen University

NCT07479979

/ RecruitingPhase 1/2IIT

Phase Ib/II Study of Selinexor in Combination With Carfilzomib, Subcutaneous Isatuximab Administered Via Investigational Device and Dexamethasone (SCID) for Patients With Relapsed and/or Relapsed Refractory Multiple Myeloma

The primary objective of this Phase Ib/II trial is to study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab-OBDS (on body delivery system) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma, who have received at least one line of therapy. The phase Ib portion comprises the safety run-in with 6-12 patients, with the option to reduce the selinexor dose from 40 mg to 20 mg if the higher dose reaches the prescribed toxicity threshold. The Phase II portion of the trial will test the Recommended Phase 2 Dose (RP2D) in an expansion cohort of up to 50 patients.

Start Date01 Jul 2026

Sponsor / Collaborator

Hoosier Cancer Research Network

[+3]

100 Clinical Results associated with Selinexor

100 Translational Medicine associated with Selinexor

100 Patents (Medical) associated with Selinexor

709

Literatures (Medical) associated with Selinexor

31 Dec 2026·ANNALS OF MEDICINE

Efficacy and safety of Ruxolitinib-based combination therapy in the patients with Myelofibrosis (MF): a systematic review and meta-analysis

Review

Author: Li, Yuxin ; Sun, Wanling ; Cao, Yaofang ; Hui, Wuhan ; Tan, Shuai

BACKGROUND:

Myelofibrosis (MF) is a chronic myeloproliferative neoplasm. Although Ruxolitinib, a JAK1/2 inhibitor, remains the cornerstone of MF treatment, it does not reverse disease progression, and resistance frequently emerges. These limitations have prompted investigation into combination therapies targeting pathways beyond the JAK-STAT axis. This meta-analysis aims to evaluate the efficacy and safety of Ruxolitinib-based combination therapies in patients with MF.

METHODS:

We conducted a systematic search of databases for studies published through August 1, 2025. Thirteen distinct Ruxolitinib-based combination regimens were included. Primary efficacy endpoints were ≥35% spleen volume reduction at 24 weeks (SVR35) and ≥50% reduction in total symptom score (TSS50). Safety endpoints focused on the incidence of grade 3/4 thrombocytopenia and anemia. Subgroup analyses were performed based on prior JAK inhibitor exposure and therapeutic mechanism of action.

RESULTS:

A total of 19 studies comprising 1,088 patients were included in the meta-analysis. Among JAK inhibitor-naïve patients, the combination of Ruxolitinib with Selinexor demonstrated the highest efficacy (SVR35: 92%; TSS50: 78%), followed by Ruxolitinib plus BMS-986158 (SVR35: 90%). For patients with prior JAK inhibitor exposure, Ruxolitinib plus Siremadlin (SVR35: 45%) showed notable activity.

CONCLUSION:

For JAK inhibitor-naïve patients, Ruxolitinib-based combination regimens demonstrated satisfactory clinical responses and the potential for meaningful disease control. For patients with prior JAK inhibitor exposure, the addition of combination therapy drugs may further enhance the efficacy. Personalized treatment selection remains essential, as therapeutic efficacy is significantly influenced by prior JAK inhibitor exposure.

01 Oct 2026·CANCER LETTERS

NPM1 mutation promotes creatine anabolism by FTO-dependent m6A demethylation to drive macrophage M2 polarization in acute myeloid leukemia

Article

Author: Lei, Xin-Xing ; Long, Zi-Jie ; Liu, Jia-Jun ; Lin, Zhi-Li ; Wang, Jun-Dan ; Liu, Quentin ; Zhang, Ling ; Liao, Chen-Jia ; Peng, Zi-Zhen

Nucleophosmin 1-mutant (NPM1^MU) acute myeloid leukemia (AML) represents a distinct molecular subtype, yet the mechanisms underlying NPM1 mutation-driven malignant transformation remain incompletely understood. Here, we find prevalent copy number variations (CNVs) of N⁶-methyladenosine (m⁶A) key regulators in NPM1 wild-type (NPM1^WT) AML patients, whereas such alterations are rarely detected in NPM1^MU subgroup. Moreover, a reduction in m⁶A modification is observed in leukemic cells overexpressing NPM1^MU protein, concomitant with an increase in FTO expression. Co-immunoprecipitation shows that NPM1^MU protein mislocates in the cytoplasm and binds to FTO to block its ubiquitin-proteasome degradation through K422 specific site. Of note, creatine metabolism-related signaling and FTO-mediated macrophage M2 polarization signaling are enriched in NPM1^MU patients according to TCGA data analysis. Indeed, FTO promotes creatine anabolism in NPM1^MU leukemic cells by stabilizing the mRNA of GAMT, a key enzyme in the creatine synthesis pathway. Creatine facilitates macrophage M2 polarization, as evidenced by the upregulation of M2 polarization-related genes (CD206, CCL2, IL-10 and CXCL13). This effect is abrogated upon FTO knockdown in leukemic cells. Selinexor, an exportin 1 inhibitor to impede NPM1^MU export from nucleus, enhances FTO degradation and reduces macrophage M2 polarization. This work reveals that FTO-creatine signaling plays an oncogenic role in NPM1^MU AML, guiding more effective therapy strategies and clinical benefits for this distinctly leukemic entity.

01 Jul 2026·AMERICAN JOURNAL OF HEMATOLOGY

Navigating the Post‐ BCMA / GPRC5D Landscape: Efficacy of Selinexor, Bortezomib, and Dexamethasone After Sequential Immunotherapy Failure in Penta‐Refractory Multiple Myeloma—A Multicenter Analysis

Article

Author: Bartke, Leandra ; Harzer, Marie ; Brioli, Annamaria ; Khandanpour, Cyrus ; Cords, Leon ; Hillmann, Stefan M. ; Al‐Bazaz, Maximilian ; Weisel, Katja ; Holtick, Udo ; Bokemeyer, Carsten ; Artzenroth, Jule ; Kamili, Abdulaziz ; Leypoldt, Lisa ; Schaefers, Christoph ; Leitner, Theo ; Vorwerk, Jan ; Salwender, Hans ; Sonnemann, Piet ; Maulhardt, Markus ; Brinkert, Kerstin ; Kosch, Ricardo ; Richardson, Tim ; Alsdorf, Winfried

ABSTRACT:

Patients with relapsed/refractory multiple myeloma (RRMM) who are penta‐drug refractory, defined as resistant to two proteasome inhibitors, two immunomodulatory agents, and an anti‐CD38 monoclonal antibody, face a dismal prognosis, particularly after exposure to T‐cell–redirecting therapies. Selinexor, an oral exportin‐1 inhibitor, offers a distinct mechanism of action and may retain efficacy in this difficult setting. We conducted a retrospective analysis at six German tertiary centers (2023–2025) to evaluate the efficacy and safety of selinexor plus bortezomib and dexamethasone (SVd) in penta‐refractory MM after both BCMA‐ and GPRC5D‐targeted therapies. Eighteen patients were identified, with a median of seven prior lines of therapy. High‐risk cytogenetic abnormalities were present in seven cases, including del17p in six. The overall response rate (ORR) was 61%, including one complete, five very good partial, and five partial responses, and median progression‐free survival (PFS) was 4.3 months. Among nine patients (50%) with extramedullary disease (EMD), three achieved complete and one near‐complete EMD resolution. Two patients who had relapsed after CAR T‐cell treatment with idecabtagene vicleucel achieved partial and very good partial responses and were successfully transitioned to a second CAR T‐cell therapy with ciltacabtagene autoleucel. Hematologic toxicities under SVd were manageable, and no treatment‐related deaths occurred. SVd demonstrates meaningful activity in patients with penta‐refractory MM and prior failure of BCMA/GPRC5D‐targeted immunotherapies. The ORR of 61%, disease control in 78% of patients, and median PFS of 4.3 months support further evaluation of SVd in this highly refractory setting after failure of BCMA‐ and GPRC5D‐directed approaches.

343

News (Medical) associated with Selinexor

22 Jun 2026

·www.prnewswire.com

Antengene Announces Exclusive License Agreement with MPM BioImpact-Established K2 Therapeutics for ATG-106 and Option for Undisclosed Bispecific TCE

ATG-106 is a first-in-class CDH6 x CD3 bispecific T cell engager (TCE) in preclinical development for the treatment of solid tumors K2 Therapeutics, established by MPM BioImpact, obtains exclusive global rights to develop and commercialize ATG-106 outside Greater China Antengene receives upfront and near-term considerations of approximately USD 20 million for ATG-106; eligible to receive up to USD 960.5 million in future milestones K2 Therapeutics enters into option agreement with Antengene to obtain exclusive global rights to develop and commercialize an undisclosed preclinical bispecific TCE candidate outside Greater China The deal underscores AnTenGager® platform's differentiated capabilities in developing next-generation novel TCEs with broad applicability, and also marks the second transaction involving an AnTenGager® TCE, following the global exclusive license agreement with UCB for ATG-201 announced in March 2026 BOSTON, SINGAPORE and HONG KONG, June 21, 2026 /PRNewswire/ -- Antengene Corporation Limited (" Antengene", SEHK: [6996 HK]), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, today announced that it has entered into an exclusive license agreement (" License Agreement") with K2 Therapeutics for ATG-106, a preclinical CDH6 x CD3 bispecific T cell engager (TCE) in development for solid tumors. Antengene also announced that it has entered into an option agreement (" Option Agreement") to grant K2 Therapeutics the option to obtain exclusive global rights to develop and commercialize an undisclosed preclinical bispecific TCE candidate. Across both the License Agreement and the Option Agreement, K2 Therapeutics' rights extend globally, excluding Greater China. K2 Therapeutics, established by MPM BioImpact, is a biotech company and scalable hub-and-spoke engine built for global impact, with search and development capabilities unconstrained by modality or geography. MPM BioImpact is a world-leading biotechnology investment firm, with over 30 years' experience creating and investing in innovative companies. "We are very pleased to expand our partnerships with our TCE pipeline with this important collaboration around our AnTenGager® platform," said Dr. Jay Mei, Founder, Chairman and Chief Executive Officer of Antengene. "We believe ATG-106, our CDH6 x CD3 bispecific TCE reflects the differentiated design of AnTenGager® TCEs and their potential in solid tumors. AnTenGager® TCEs are designed to address key challenges that have historically limited first-generation TCEs in solid tumors, particularly with respect to safety and tolerability. By combining steric hindrance-based masking with our proprietary fast on/off CD3 binder, AnTenGager® TCEs are designed to activate T cells in a disease-associated antigen-gated manner, with the potential to reduce cytokine release syndrome and T cell exhaustion while maintaining potent anti-tumor activity." Both ATG-106 and the undisclosed program leverage Antengene's proprietary AnTenGager® platform, which offers a differentiated TCE approach, where binding of the TCE arm (CD3) is sterically masked in the absence of target antigen binding providing potent activity and better tolerability. "We are excited to license ATG-106, a highly differentiated CDH6 x CD3 bispecific TCE, as well as a second promising TCE program enabled by the cutting-edge AnTenGager® platform," said Frank Neumann, M.D., Ph.D., Chief Medical Officer of K2 Therapeutics. "CDH6 is an attractive target given its overexpression in tumors such as ovarian and renal cancers, and its limited expression in normal adult tissues. We believe the unique design of ATG-106 has the potential to meaningfully advance the field of solid tumor TCEs. We look forward to advancing ATG-106 toward the clinic and to delivering meaningful benefit to patients." Under the License Agreement, Antengene is entitled to upfront and near-term considerations of approximately USD 20 million, consisting of cash and a minority equity stake in a newly established asset company and subsidiary of K2 Therapeutics, subject to the satisfaction of certain near-term conditions. Antengene is also eligible to receive developmental, regulatory and sales milestone payments of up to USD 960.5 million related to ATG-106, plus tiered royalties on future net sales. Under the Option Agreement, upon exercise of the option, Antengene is entitled to receive upfront and near-term considerations of approximately USD 20 million, consisting of an option exercise fee, near-term payment and upfront payment, as well as a minority equity stake in the related asset company. Antengene would also be eligible to receive developmental, regulatory and sales milestone payments of up to USD 960.5 million related to the undisclosed TCE program, plus tiered royalties on future net sales. About Antengene Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) is a global, R&D-driven, commercial-stage biotech company focused on developing first-in-class/best-in-class therapeutics for diseases with significant unmet medical needs. Its pipeline spans from preclinical to commercial stages, with key investigational candidates including ATG-022 (CLDN18.2 ADC), ATG-037 (oral CD73 inhibitor), ATG-101 (PD-L1 x 4-1BB bispecific antibody), ATG-125 (B7-H3 × PD-L1 bispecific ADC), ATG-207 (αCD3-TGF-β bifunctional fusion protein), as well as T cell engager (TCE) programs developed using Antengene's proprietary AnTenGager® platform. AnTenGager®, is Antengene's proprietary TCE 2.0 platform, featuring "2+1" bivalent binding for low expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform's broad applicability across autoimmune disease, solid tumors and hematological malignancies, with programs targeting CD19 x CD3 (ATG-201 for B cell-related autoimmune diseases; partnered with UCB), CDH6 x CD3 (ATG-106 for ovarian cancer and kidney cancer), ALPPL2 x CD3 (ATG-112 for gynecological tumors, digestive system malignancies, bladder cancer and NSCLC), LY6G6D x CD3 (ATG-110 for microsatellite-stable colorectal cancer), GPRC5D x CD3 (ATG-021 for multiple myeloma), LILRB4 x CD3 (ATG-102 for acute myeloid leukemia and chronic myelomonocytic leukemia) and FLT3 x CD3 (ATG-107 for acute myeloid leukemia). To date, Antengene has obtained 33 investigational new drug (IND) approvals in the U.S. and Asia, and obtained new drug application (NDA) approvals in 10 Asia Pacific markets. Its lead commercial asset, XPOVIO® (selinexor), is approved in the Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia, and has been included in the national insurance schemes in five of these markets (Mainland of China, Taiwan China, Australia, South Korea and Singapore). About K2 Therapeutics K2 Therapeutics is a biotech company built for global impact, with search and development capabilities unconstrained by modality or geography. K2 Therapeutics identifies the world's most innovative assets and translates them into great medicines through a disciplined development approach led by experienced drug developers. The Company aims to build a pipeline focused on high-potential first- and best-in-class assets with meaningful potential for patient impact worldwide. About MPM BioImpact MPM BioImpact is a world-leading biotechnology investment firm with over 30 years of expertise creating and investing in innovative companies to deliver transformative therapies to patients. Its experienced and dedicated team of investment professionals, entrepreneurs, advisors and leading scientists translate scientific discoveries into breakthrough medicines and potential cures. The Firm manages over $3.5 billion AUM across early-stage venture funds, private/public impact funds and public equities funds. For more information, visit 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, 2025, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] BD Contacts: Ariel Guo E-mail: [email protected] SOURCE Antengene Corporation Limited 21% more press release views with Request a Demo

License out/inDrug ApprovalNDA

15 Jun 2026

·www.prnewswire.com

Antengene Receives IND Approval for ATG-201 (CD19 × CD3 TCE) in Autoimmune Disease in China

June 9, 2026 -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, today announced that China's National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for the Phase I ATTRACT study of ATG-201, a CD19/CD3 bispecific T-cell engager antibody, for the treatment of B cell related autoimmune diseases. ATG-201 is a CD19 targeting bispecific TCE incorporating steric hindrance masking technology, designed to eliminate CD19-expressing B cells. This bispecific interaction with T and B cells through CD3 and CD19 has demonstrated potential in treating B cell-driven diseases by leveraging the body's own immune system for precise and potent action. Antengene plans to promptly initiate and advance the Phase I ATTRACT study in China, while concurrently preparing for the clinical development of ATG-201 in Australia. The ATTRACT study will be led by Prof. Zhanguo Li from Peking University People's Hospital as the principal investigator. This is a Phase I clinical study designed to evaluate the safety, tolerability and preliminary efficacy of ATG-201 monotherapy in adult patients with B cell related autoimmune diseases. The study will consist of two phases: dose escalation and dose expansion. The primary objectives of the study are to evaluate the safety and tolerability of ATG-201 monotherapy and to determine its recommended Phase II dose (RP2D). Secondary objectives include evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) profiles, immunogenicity, preliminary efficacy of ATG-201. Professor Zhanguo Li stated, "It is a great honor to lead the first-in-human (FIH) trial of Antengene's investigational drug ATG-201. Significant unmet clinical needs remain in patients with refractory B cell‑mediated autoimmune diseases, including low remission rates, high relapse risk, and long‑term safety concerns. ATG‑201, a dual CD3/CD19 T‑cell engager, redirects and activates autologous T cells to achieve precise elimination of pathogenic B cells—a novel mechanism that may overcome current therapeutic limitations. Our team, in close collaboration with the sponsor, Antengene, will rigorously conduct this Phase I study to evaluate the safety and preliminary efficacy." Antengene and UCB have entered into an agreement that grants UCB a worldwide exclusive license to develop, manufacture, and commercialize ATG-201, along with access to its associated manufacturing technology. Antengene will conduct the FIH phase I clinical trials in China and Australia, and thereafter transfer all further clinical development activities to UCB. The clinical trial application approval of ATG-201 by China's NMPA marks a critical step forward for Antengene as the company expands its strategic focus from oncology and hematology to include autoimmune diseases. This milestone demonstrates Antengene's determination and strong execution capabilities as it actively expands into autoimmune diseases, a therapeutic area with significant unmet need and growth potential. Looking ahead, Antengene will remain guided by unmet clinical needs, and continue to develop more first-in-class and/or best-in-class innovative therapies, bringing transformative treatment options to patients worldwide. Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a global, R&D-driven, commercial-stage biotech company focused on developing first-in-class/best-in-class therapeutics for diseases with significant unmet medical needs. Its pipeline spans from preclinical to commercial stages, with key investigational candidates including ATG-022 (CLDN18.2 ADC), ATG-037 (oral CD73 inhibitor), ATG-101 (PD-L1 x 4-1BB bispecific antibody), ATG-125 (B7-H3 × PD-L1 bispecific ADC), ATG-207 (αCD3-TGF-β bifunctional fusion protein), as well as T cell engager (TCE) programs developed using Antengene's proprietary AnTenGager® platform. AnTenGager®, is Antengene's proprietary TCE 2.0 platform, featuring "2+1" bivalent binding for low expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform's broad applicability across autoimmune disease, solid tumors and hematological malignancies, with programs targeting CD19 x CD3 (ATG-201 for B cell-related autoimmune diseases; partnered with UCB), CDH6 x CD3 (ATG-106 for ovarian cancer and kidney cancer), ALPPL2 x CD3 (ATG-112 for gynecological tumors, digestive system malignancies, bladder cancer and NSCLC), LY6G6D x CD3 (ATG-110 for microsatellite-stable colorectal cancer), GPRC5D x CD3 (ATG-021 for multiple myeloma), LILRB4 x CD3 (ATG-102 for acute myeloid leukemia and chronic myelomonocytic leukemia) and FLT3 x CD3 (ATG-107 for acute myeloid leukemia). To date, Antengene has obtained 33 investigational new drug (IND) approvals in the U.S. and Asia, and obtained new drug application (NDA) approvals in 10 Asia Pacific markets. Its lead commercial asset, XPOVIO® (selinexor), is approved in the Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia, and has been included in the national insurance schemes in five of these markets (Mainland of China, Taiwan China, Australia, South Korea and Singapore). The content above comes from the network. if any infringement, please contact us to modify.

License out/inINDDrug Approval

14 Jun 2026

·www.prnewswire.com

Menarini Group Reports Data from the Phase 3 SENTRY Trial of Selinexor Plus Ruxolitinib in Myelofibrosis at The European Hematology Association (EHA) 2026 Congress

The combination of selinexor plus ruxolitinib met the first co-primary endpoint demonstrating a statistically significant improvement of spleen volume reduction (SVR35) of 49.8% for the combination arm vs 28% for the control arm at week 24. Post-hoc analysis from the phase 3 SENTRY trial suggests SVR35 may predict overall survival (OS); new data from the phase 1 SENTRY trial demonstrates a similar finding. Data selected by EHA's Scientific Program Committee for late-breaking oral presentation. Data stems from the pivotal study conducted in collaboration with Karyopharm Therapeutics, Inc. FOR MEDICAL AND PHARMACEUTICAL TRADE MEDIA ONLY FLORENCE, Italy and NEW YORK, June 14, 2026 /PRNewswire/ -- 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, announced that new data related to the pivotal Phase 3 SENTRY trial will be presented as a late-breaking oral[i] at The European Hematology Association (EHA) 2026 Congress. SENTRY (NCT04562389), a pivotal Phase 3 trial, is a randomized, double-blind, placebo-controlled trial of 60 mg selinexor in combination with ruxolitinib in frontline myelofibrosis (MF) (n=353), versus ruxolitinib monotherapy. Conducted by Karyopharm Therapeutics, Inc., in collaboration with the Menarini Group, SENTRY was designed to evaluate two co-primary endpoints: spleen volume reduction of 35% or more (SVR35) and absolute total symptom score (Abs-TSS). The trial met the first co-primary endpoint, demonstrating that patients who were treated with the combination of selinexor plus ruxolitinib achieved a clear and statistically significant improvement in SVR35, compared to patients who received ruxolitinib alone. These results highlight that the combination arm enabled rapid, deep and sustained spleen volume reductions. "Achievement of spleen reduction is the essential goal of myelofibrosis treatment. Importantly, the spleen reduction results seen in SENTRY were rapid, deep and durable, and associated with potential overall survival benefit for the patients receiving the combination," said Dr. Claire Harrison, Professor of Myeloproliferative Neoplasms and Deputy Chief Medical Officer at Guy's and St. Thomas' NHS Foundation Trust. "We are encouraged that these results represent a potential new therapeutic advance for our patients who are in dire need of better options." Other key highlights include: Absolute Total Symptom Score (Abs-TSS): The combination arm demonstrated a comparable benefit to ruxolitinib alone, with a 9.9 point improvement in Abs-TSS at week 24, in patients who received the combination, compared to a 10.9 point improvement in patients who received ruxolitinib alone. The difference across the two arms was not statistically significant, and the combination arm did not meet this second co-primary endpoint. Overall Survival (OS): While these data were immature at the time of analysis, a promising early OS signal, a pre-specified secondary endpoint, was observed with the selinexor combination compared to ruxolitinib alone. The study showed a greater than 50% reduction in the risk of death for patients receiving the selinexor combination (HR 0.43). Spleen Volume Reduction: Consistent SVR35 benefit was observed across prespecified subgroups. Notably, at week 24, superior spleen volume reduction was achieved by the selinexor combination, regardless of the ruxolitinib dose, including by patients receiving less than 15 mg of ruxolitinib per day. Variant Allele Frequency (VAF) Reduction: This pre-specified exploratory endpoint, which is associated with SVR35, was observed in 32% of patients in the selinexor plus ruxolitinib arm at week 24 versus 23.9% of patients treated with ruxolitinib alone, indicating the combination's potential for disease modification. Safety and Tolerability: The combination demonstrated a manageable safety and tolerability profile consistent with the known profile of selinexor and ruxolitinib individually. No new safety signals were observed. "The strength of the spleen response and the encouraging early overall survival data observed in the SENTRY study creates hope for a potential new treatment option for patients suffering from this devastating disease with dismal outcomes," said Elcin Barker Ergun, CEO of the Menarini Group. "Our dedication and commitment to bring transformational treatments to patients facing cancer is stronger than ever." About Myelofibrosis (MF) Myelofibrosis (MF) is a type of blood cancer that belongs to a group of diseases called Myeloproliferative Neoplasms (MPNs). These diseases are caused by the overgrowth of abnormal blood-forming cells in the bone marrow, which leads to the formation of scar tissue. This scarring makes it difficult for the body to produce healthy blood cells. The incidence of MF is rare, with only about one or two people diagnosed each year for every 100,000 individuals, and the median survival after diagnosis is six years. Additionally, for people living with MF, their quality of life can be compromised by symptoms including fatigue, an enlarged spleen, and low blood counts, all of which are caused by the disease. 1,2,3 To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at [email protected]. All of the relevant information can be found at Please see Summary of Product Characteristics (SmPC) and European Public Assessment Report at . Please refer to local prescribing information where selinexor is approved for full information. Menarini Group holds licensing rights for selinexor and currently markets it in numerous European countries and global territories. In the U.S., Karyopharm Therapeutics markets selinexor and the full prescribing information is available here. About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $5.5 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 . 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. References 1. Myelofibrosis. NORD (National Organization for Rare Disorders). 2. Myelofibrosis. The Leukemia & Lymphoma Society (LLS). 3. Myelofibrosis. Mayo Clinic. [i] The safety and efficacy of the investigational combinations and unapproved indications discussed in this press release have not been established by the FDA, EMA, or any other regulatory authority. 21% more press release views with Request a Demo

Clinical ResultPhase 3License out/inDrug Approval

100 Deals associated with Selinexor

External Link

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	China	Karyopharm Therapeutics, Inc.	14 Dec 2021
Relapse multiple myeloma	China	Karyopharm Therapeutics, Inc.	14 Dec 2021
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
Post-polycythemia vera myelofibrosis	Phase 3	United States	Karyopharm Therapeutics, Inc.	11 Mar 2021
Post-polycythemia vera myelofibrosis	Phase 3	Australia	Karyopharm Therapeutics, Inc.	11 Mar 2021
Post-polycythemia vera myelofibrosis	Phase 3	Belgium	Karyopharm Therapeutics, Inc.	11 Mar 2021
Post-polycythemia vera myelofibrosis	Phase 3	Bulgaria	Karyopharm Therapeutics, Inc.	11 Mar 2021
Post-polycythemia vera myelofibrosis	Phase 3	Canada	Karyopharm Therapeutics, Inc.	11 Mar 2021
Post-polycythemia vera myelofibrosis	Phase 3	Czechia	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


NCT04562389 (SENTRY, EHA2026)	Phase 3	Myelofibrosis	353	Selinexor+Ruxolitinib	rapuoozpzi(jjwqksxrro) = ppmpjxebvb mcctugwakx (wuxbgmkvym ) View more	Positive	02 Jun 2026
				Placebo+Ruxolitinib	rapuoozpzi(jjwqksxrro) = xxmfkxounj mcctugwakx (wuxbgmkvym ) View more
NCT02835222 (ASCO2026)	Phase 2	Acute Myeloid Leukemia	57	Selinexor + standard intensive induction and consolidation chemotherapy	zxinbvgtxk(rnimwqqngb) = bmfovxfbnc chrlhcqnuz (xznbqkbbjv ) View more	Positive	29 May 2026
				Standard intensive induction and consolidation chemotherapy	zxinbvgtxk(rnimwqqngb) = aqczdbpiyt chrlhcqnuz (xznbqkbbjv ) View more
EHA2026	Phase 2	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome	20	Decitabine, Venetoclax, and Selinexor (DVS) regimen	wwawhqbeyt(celqukxfvp) = wvfxychzrb snkzibmpcu (uzeglzqrun ) View more	Positive	12 May 2026
NCT06062641 (EHA2026)	Phase 2	Diffuse large B-cell lymphoma recurrent TP53 mutation \| TP53 deletion	47	Selinexor + R-GDP	hvhmnmqthk(nwrogitgcz) = tthnqzesgg jxhqnkzhxd (grlebrdyne ) View more	Positive	12 May 2026
ChiCTR2300069941 (EHA2026)	Phase 1	AIDS-Related Diffuse Large Cell Lymphoma First line	10	Selinexor plus R-EPOCH (HIV-associated DLBCL)	nhxsfghwrb(dbzspovoce) = ljhytdkiyj tnlatkombl (ibtorvtxtf ) View more	Positive	12 May 2026
EUCTR2021-006229-23-IT (EHA2026)	Phase 2	Peripheral T-Cell Lymphoma	30	Selinexor+Ifosfamide+Etoposide+Dexamethasone	hxtnxagxrm(stopaoorga) = hvyjxiwrkv wnucwhnnwk (mnnmgdtxvm ) View more	Negative	12 May 2026
ChiCTR2500104950 (EHA2026)	Phase 2	Refractory acute myeloid leukemia	16	Selinexor + Decitabine + Dose-Adjusted CMG	wwwdtamibq(uysufmldqd) = rzaoqoipwa hjrkesxmzu (srgdztzpun ) View more	Positive	12 May 2026
				Selinexor + Decitabine + Dose-Adjusted CMG (early salvage therapy (1-2 prior lines))	wwwdtamibq(uysufmldqd) = nttvurxvzs hjrkesxmzu (srgdztzpun ) View more
EHA2026	Not Applicable	Acute Myeloid Leukemia \| Refractory acute myeloid leukemia	45	XAB regimen	bzsrvnsycd(gnmqgkibxg) = eoldzcmkpc zclacmqmhk (sbpwsbdodt ) View more	Positive	12 May 2026
				XAB regimen (newly diagnosed (ND) AML)	bzsrvnsycd(gnmqgkibxg) = lebobreiom zclacmqmhk (sbpwsbdodt ) View more
EHA2026	Phase 1	High Risk Myelodysplastic Syndrome	6	Standard regimen: Azacitidine 75 mg/m² D1-7 + Selinexor 60 mg D1,8,15 (28-day cycle)	wqnuncrffn(astpxxvywy) = jkjygdselz vhkjjsvhiz (geoivcldsc )	Positive	12 May 2026
NCT05980806 (SENTRY2, EHA2026)	Phase 2	Myelofibrosis	58	Selinexor 40 mg QW	buvfkxnbhv(jqdypovcdj) = uqndfjihyt rmdbasmhml (oiewmreiop ) View more	Positive	12 May 2026
				Selinexor 60 mg QW	buvfkxnbhv(jqdypovcdj) = lyhgrxzvug rmdbasmhml (oiewmreiop ) View more

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