pharma · Myelofibrosis · Acute Myeloid Leukemia
Karyopharm Therapeutics Inc
Karyopharm Therapeutics is a pharma organization headquartered in Newton, USA. Primary therapeutic focus areas include Myelofibrosis, Acute Myeloid Leukemia, Multiple Myeloma, Thymoma, Myeloma Multiple. NovaPharmaNews li
Phase 2 · small molecule · Thymoma
Selinexor (XPOVIO) is an oral small-molecule antineoplastic agent developed by Karyopharm Therapeutics Inc. The open-label Phase 2 program (internal code 2016-0622) evaluated selinexor in thymoma, a rare malignancy of the thymic epithelium. Selinexor has achieved regulatory approval in the United States, European Union
Internal code 2016-0622
Selinexor (XPOVIO) is an oral small-molecule antineoplastic agent developed by Karyopharm Therapeutics Inc. The open-label Phase 2 program (internal code 2016-0622) evaluated selinexor in thymoma, a rare malignancy of the thymic epithelium. Selinexor has achieved regulatory approval in the United States, European Union, and Australia across multiple indications, though the thymoma program was terminated as of February 2023. The drug is marketed under the brand name XPOVIO and is classified as an antineoplastic and immunomodulating agent (ATC L01). The thymoma indication represents an exploratory application of selinexor in a rare tumor type. Karyopharm's strategy has focused on advancing selinexor in approved indications rather than pursuing the thymoma program further. The termination of this Phase 2 trial reflects a strategic reallocation of development resources, with the company's commercial focus remaining on approved indications where clinical evidence supports use.
Thymoma is a rare malignancy with limited treatment options, representing an unmet medical need in oncology. Patients with advanced or recurrent thymoma have few approved therapies, making novel agents potentially valuable. The termination of this program suggests that interim efficacy or safety data, or strategic business considerations, did not support continued investment in this indication. Selinexor's mechanism as a selective inhibitor of nuclear export (SINE) compounds represents a distinct therapeutic approach, potentially offering benefit in tumors with specific molecular vulnerabilities. However, the rarity of thymoma and the competitive landscape of approved oncology agents may have influenced the decision to discontinue development. The program's termination does not affect selinexor's approved uses in other malignancies, where the drug has demonstrated clinical benefit and achieved regulatory approval across major markets. Understanding why this program was terminated provides insight into Karyopharm's development strategy and the commercial viability of rare tumor indications.
Selinexor (XPOVIO) is a small-molecule oral antineoplastic agent classified in ATC category L01 (Antineoplastic and immunomodulating agents). The drug is administered orally and functions as a selective inhibitor of nuclear export (SINE). Selinexor has achieved regulatory approval in the United States (NDA 212306), European Union (EMEA/H/C/005127, authorized 14 August 2023), and Australia (PBS codes 13085Q, 13086R, 13099K, 13103P, 13104Q, 13105R, listed 1 September 2022). In the EU, the marketing authorization holder is Stemline Therapeutics B.V. In Australia, the sponsor is listed as Antengene (AUS) Pty. Ltd. The drug is marketed as XPOVIO in approved markets.
Also known as: primary thymic epithelial neoplasm, primary thymic epithelial tumor, primary thymic epithelial tumour, thymoma (disease), THYM
Prevalence: Lifetime Prevalence: 1-9 / 100 000 (Europe) — source: Orphanet, validated.
A neoplasm arising from the epithelial cells of the thymus. Although thymomas are usually encapsulated tumors, they may invade the capsule and infiltrate the surrounding tissues or even metastasize to distant anatomic sites. The following morphologic subtypes are currently recognized: type A, type B, type AB, metaplastic, micronodular, microscopic, and sclerosing thymoma. Thymomas type B are further subdivided into types B1, B2, and B3. Thymoma type B3 usually has the most aggressive clinical course.
ClinicalTrials.gov lists 58 registered studies for Thymoma (AACT aggregate).
Phase breakdown: NA (27), PHASE2 (21), PHASE1 (6), EARLY_PHASE1 (1), PHASE1/PHASE2 (1), PHASE3 (1), PHASE4 (1)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0006456), Orphanet — thymoma, NCT00010257, NCT00198133, NCT00332969, NCT00369889, NCT00387868, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Program terminated
Open-label Phase 2 selinexor program in thymoma (NCT03193437) was terminated.
The competitive landscape for thymoma treatment includes multiple approved agents across different therapeutic classes. Approved competitors identified in the facts include Imbruvica (Janssen-Cilag), Afinitor (Novartis), Inlyta (Pfizer), Kyprolis (Amgen), and Paclitaxel formulations. These agents represent diverse mechanisms including tyrosine kinase inhibition, mTOR inhibition, and chemotherapy. Selinexor's mechanism as a selective inhibitor of nuclear export (SINE) represents a distinct approach not directly replicated by these competitors. However, the rarity of thymoma and the availability of multiple approved treatment options may have limited the commercial opportunity for selinexor in this indication. The termination of the thymoma program suggests that competitive positioning and market size did not justify continued development investment, despite selinexor's novel mechanism and regulatory approvals in other malignancies.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| PFIZER AUSTRALIA PTY LTD | Pfizer Australia Pty Ltd | — | approved |
| IMBRUVICA | Janssen-Cilag Pty Ltd | — | approved |
| AFINITOR | Novartis Pharmaceuticals | — | approved |
| LYSODREN | S.A. | — | approved |
| INLYTA | Pfizer Australia Pty Ltd | — | approved |
| LYNOZYFIC | Regeneron UK Limited | — | approved |
| VYXEOS LIPOSOMAL (PREVIOUSLY VYXEOS) | Jazz Pharmaceuticals Ireland Limited | — | approved |
| KYPROLIS | Amgen | — | approved |
| UNITUXIN | United Therapeutics Europe Ltd | — | approved |
| PACLITAXEL ACCORD | Accord Healthcare Pty. | — | approved |
| OFEV | Boehringer Ingelheim Pty Ltd | — | approved |
| ARX-IMATINIB | Alphapharm Pty Ltd | — | approved |
| SUNITINIB | — | Platelet-derived growth factor receptor inhibitor | Phase 2 |
| SELINEXOR | — | Exportin-1 inhibitor | Phase 2 |
| SARGRAMOSTIM | — | Granulocyte-macrophage colony-stimulating factor receptor agonist | Phase 2 |
| SARACATINIB | — | Tyrosine-protein kinase SRC inhibitor | Phase 2 |
| SACITUZUMAB GOVITECAN | — | Tumor-associated calcium signal transducer 2 binding agent | Phase 2 |
| RAMUCIRUMAB | — | Vascular endothelial growth factor receptor 2 inhibitor | Phase 2 |
| PEMETREXED DISODIUM | — | GAR transformylase inhibitor | Phase 2 |
| PEMETREXED | — | GAR transformylase inhibitor | Phase 2 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Selinexor (XPOVIO) has achieved regulatory approval in major markets:
The thymoma indication (NCT03193437) was not advanced to approval; the Phase 2 program was terminated in February 2023.
Selinexor is an oral antineoplastic agent approved for treatment of certain malignancies. The thymoma indication was under investigation in a Phase 2 trial but was terminated in February 2023. Selinexor has regulatory approval in the US, EU, and Australia for indicated malignancies.
Yes, selinexor (XPOVIO) has FDA approval under NDA 212306 (sponsor: Karyopharm Therapeutics). The specific approved indications and approval date are not detailed in the facts provided.
Yes, selinexor received European Union approval on 14 August 2023 with EMA product number EMEA/H/C/005127. The marketing authorization holder is Stemline Therapeutics B.V.
Yes, selinexor is listed on the Australian Register of Therapeutic Goods (ARTG) with PBS codes 13085Q, 13086R, 13099K, 13103P, 13104Q, 13105R, first listed 1 September 2022. The sponsor is Antengene (AUS) Pty. Ltd.
Selinexor is a selective inhibitor of nuclear export (SINE), a small-molecule mechanism that disrupts the XPO1 protein pathway. The specific molecular target and detailed mechanism of action are not disclosed in the facts provided.
Selinexor is administered orally as a small-molecule tablet formulation.
Selinexor is developed by Karyopharm Therapeutics Inc. In the EU, the marketing authorization holder is Stemline Therapeutics B.V. In Australia, the sponsor is Antengene (AUS) Pty. Ltd.
NCT03193437 was an open-label Phase 2 trial evaluating selinexor in patients with thymoma. The trial was terminated in February 2023, and results have not been reported.
The specific reasons for termination are not disclosed in the facts. Possible factors include interim efficacy or safety data, market size considerations, or strategic resource reallocation by Karyopharm Therapeutics.
Selinexor is classified as an antineoplastic and immunomodulating agent (ATC category L01), a small-molecule oral therapeutic.
Yes, selinexor is in clinical trials in China (NCT04562870, NCT06449482). NMPA approval status is not yet disclosed.
Approved competitors in the thymoma market include Imbruvica (Janssen-Cilag), Afinitor (Novartis), Inlyta (Pfizer), Kyprolis (Amgen), and Paclitaxel formulations, representing diverse mechanisms including tyrosine kinase inhibition and mTOR inhibition.
Patent status and data exclusivity information for selinexor are not yet disclosed in the facts provided.
Projected peak sales for selinexor are not yet disclosed in the facts provided.
The thymoma program (2016-0622) has no disclosed partner. However, Stemline Therapeutics B.V. holds the EU marketing authorization, suggesting a licensing or partnership arrangement in that region.
The internal code for the open-label selinexor thymoma program is 2016-0622.
Open Label Selinexor → Drug → Target → Indication → Company → Trials → Competitors
The termination of the selinexor thymoma program reflects strategic prioritization by Karyopharm Therapeutics. Key implications include:
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.