Oral selinexor-dexamethasone for triple-class refractory multiple myeloma.
Open accessAbstract
BACKGROUND: Selinexor, a selective inhibitor of nuclear export compound that blocks exportin 1 (XPO1) and forces nuclear accumulation and activation of tumor suppressor proteins, inhibits nuclear factor κB, and reduces oncoprotein messenger RNA translation, is a potential novel treatment for myeloma that is refractory to current therapeutic options. METHODS: We administered oral selinexor (80 mg) plus dexamethasone (20 mg) twice weekly to patients with myeloma who had previous exposure to bortezomib, carfilzomib, lenalidomide, pomalidomide, daratumumab, and an alkylating agent and had disease refractory to at least one proteasome inhibitor, one immunomodulatory agent, and daratumumab (triple-class refractory). The primary end point was overall response, defined as a partial response or better, with response assessed by an independent review committee. Clinical benefit, defined as a minimal response or better, was a secondary end point. RESULTS: A total of 122 patients in the United States and Europe were included in the modified intention-to-treat population (primary analysis), and 123 were included in the safety population. The median age was 65 years, and the median number of previous regimens was 7; a total of 53% of the patients had high-risk cytogenetic abnormalities. A partial response or better was observed in 26% of patients (95% confidence interval, 19 to 35), including two stringent complete responses; 39% of patients had a minimal response or better. The median duration of response was 4.4 months, median progression-free survival was 3.7 months, and median overall survival was 8.6 months. Fatigue, nausea, and decreased appetite were common and were typically grade 1 or 2 (grade 3 events were noted in up to 25% of patients, and no grade 4 events were reported). Thrombocytopenia occurred in 73% of the patients (grade 3 in 25% and grade 4 in 33%). Thrombocytopenia led to bleeding events of grade 3 or higher in 6 patients. CONCLUSIONS: Selinexor-dexamethasone resulted in objective treatment responses in patients with myeloma refractory to currently available therapies. (Funded by Karyopharm Therapeutics; STORM ClinicalTrials.gov number, NCT02336815.).
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These efficacy results compare favorably with results in similarly heavily pretreated patients with relapsed or refractory myeloma treated with selinexor plus dexamethasone and belantamab mafodotin (median progression-free survival, 3.7 months and 2.9 months, respectively).
“These efficacy results compare favorably with results in similarly heavily pretreated patients with relapsed or refractory myeloma treated with two recently approved regimens, selinexor plus dexamethasone and belantamab mafodotin (median progression-free survival, 3.7 months and 2.9 months, respectively).5,17”
From Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. (2021) · cites this paper as [5]
Recently approved therapies such as selinexor, belantamab mafodotin, idecabtagene vicleucel, and ciltacabtagene autoleucel have had clinical benefit in patients with relapsed or refractory multiple myeloma.
“Recently approved therapies such as selinexor, 9 belantamab mafodotin, 10 idecabtagene vicleucel, 11 and ciltacabtagene autoleucel 12 have had clinical benefit in patients with relapsed or refractory multiple myeloma.”
From Talquetamab, a T-Cell–Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma (2022) · cites this paper as [9]
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Self-citation
- Authors
- Chari, A., Vogl, D. T., Gavriatopoulou, M., Nooka, A. K., Yee, A. J., Huff, C. A., Moreau, P., Dingli, D., Cole, C., Lonial, S., Dimopoulos, M., Stewart, A. K., Richter, J., Vij, R., Tuchman, S., Raab, M. S., Weisel, K. C., Delforge, M., Cornell, R. F., Kaminetzky, D., Hoffman, J. E., Costa, L. J., Parker, T. L., Levy, M., Schreder, M., Meuleman, N., Frenzel, L., Mohty, M., Choquet, S., Schiller, G., Comenzo, R. L., Engelhardt, M., Illmer, T., Vlummens, P., Doyen, C., Facon, T., Karlin, L., Perrot, A., Podar, K., Kauffman, M. G., Shacham, S., Li, L., Tang, S., Picklesimer, C., Saint-Martin, J.-R., Crochiere, M., Chang, H., Parekh, S., Landesman, Y., Shah, J., Richardson, P. G., & Jagannath, S.
- Affiliations
- Emory University (US)
- Johns Hopkins University (US)
- Mayo Clinic (US)
- Hackensack University Medical Center (US)
- University of North Carolina at Chapel Hill (US)
- University of Miami (US)
- Université Libre de Bruxelles (BE)
- Hôpital Necker-Enfants Malades (FR)
- Tufts Medical Center (US)
- From the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai (A.C., S.P., S.J.), and New York University Langone Medical Center (D.K.) — both in New York; the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia (D.T.V.); the School of Medicine, National and Kapodistrian University of Athens, Athens (M.G., M. Dimopoulos); the Winship Cancer Institute, Emory University, Atlanta (A.K.N., S.L.); Massachusetts General Hospital Cancer Center (A.J.Y.),...
- ORCID
- Chari, Ajai
- Vogl, Dan T.
- Gavriatopoulou, Maria
- Nooka, Ajay K.
- Yee, Andrew J.
- Huff, Carol A.
- Moreau, Philippe
- Dingli, David
- Cole, Craig
- Lonial, Sagar
- Dimopoulos, Meletios
- Stewart, A. Keith
- Richter, Joshua
- Vij, Ravi
- Tuchman, Sascha
- Raab, Marc S.
- Weisel, Katja C.
- Cornell, Robert F.
- Kaminetzky, David
- Hoffman, James E.
- Costa, Luciano J.
- Levy, Moshe
- Schreder, Martin
- Meuleman, Nathalie
- Frenzel, Laurent
- Mohty, Mohamad
- Choquet, Sylvain
- Schiller, Gary
- Comenzo, Raymond L.
- Engelhardt, Monika
- Vlummens, Philip
- Doyen, Chantal
- Facon, Thierry
- Karlin, Lionel
- Perrot, Aurore
- Podar, Klaus
- Kauffman, Michael G.
- Li, Lingling
- Tang, Shijie
- Parekh, Samir
- Landesman, Yosef
- Richardson, Paul G.
- Jagannath, Sundar
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-08-22
- Volume
- 381
- Issue
- 8
- Pages
- 727-738
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2969931905
- Semantic Scholar
- 5a966a1e1eeb042d1a1db75214410e82f8494172
- Cited by
- 666
- References
- 34
- Citations by year
- 2026: 45 · 2025: 66 · 2024: 80 · 2023: 99 · 2022: 122 · 2021: 136 · 2020: 106 · 2019: 10 · 2018: 1
- FWCI
- 66.88
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Digital Access to Libraries (Université catholique de Louvain (UCL), l'Université de Namur (UNamur) and the Université Saint-Louis (USL-B)) (submittedVersion, other-oa)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion, other-oa)
- Lirias (KU Leuven) (submittedVersion)
- Funders
- Karyopharm Therapeutics
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Keywords
- selinexor, dexamethasone, multiple myeloma, triple-class refractory myeloma, XPO1 inhibitor, CRM1, oral administration, overall response rate, progression-free survival, thrombocytopenia, adverse events, treatment safety, lenalidomide, bortezomib, daratumumab, immunomodulators
- MeSH terms
- Exportin 1 Protein, Administration, Oral, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Drug Administration Schedule, Female, Humans, Hydrazines, Male, Middle Aged, Multiple Myeloma, Thrombocytopenia, Triazoles, Biomarkers, Tumor, Survival Analysis, Receptors, Cytoplasmic and Nuclear, Drug Resistance, Neoplasm, Karyopherins, Young Adult, Intention to Treat Analysis
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