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    STORM Part 2 clinical trial: A multicenter, single-arm, open-label study of adult patients with relapsed refractory multiple myeloma (RRMM)1

    • In STORM Part 2, 122 adult patients were treated with XPOVIO® (selinexor) 80 mg in combination with dexamethasone 20 mg on Days 1 and 3 of every week in 28-day cycles
    • The approval of XPOVIO + dexamethasone was based upon the efficacy and safety in a prespecified subgroup analysis of the 83 adult patients whose disease was refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab, as the benefit-risk ratio appeared to be greater in this more heavily pretreated population than in the overall trial population (N=122)

    The clinical trial included patients who had high-risk cytogenetics and rapidly progressing disease2

    100%

    of patients (N=83) were refractory to1

    • Lenalidomide
    • Pomalidomide
    • Bortezomib
    • Carfilzomib
    • Daratumumab
    57%

    of patients had high-risk cytogenetics1

    Includes any of the following:

    • del(17p/p53)
    • t(14;16)
    • t(4;14)
    • 1q21
    22%

    median
    increase in
    disease burden3

    between screening and first day of therapy (n=107)

    • 81% of patients enrolled had received a prior stem cell transplant
    Baseline patient demographics1
    N=83
    Median age
    65 years
    Age ≥75 years
    15%
    Male
    61%
    Female
    39%
    Median years from diagnosis to start of study treatment
    7 (range: 1-23)
    Median prior treatment regimens*
    8 (range: 4-18)
    ≥8 prior treatment regimens4
    54.2%
    *Treatment regimen=line of therapy.

    XPOVIO + dexamethasone clinical trial results demonstrated clinically significant responses in adult patients with RRMM whose disease was refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab (N=83)1

    Graphic used to show the differences in overall response rate of patients Graphic used to show the differences in overall response rate of patients
    Selinexor + dexamethasone is included in the National Comprehensive Cancer Network Guidelines (NCCN Guidelines®) as a category 2A recommendation for patients who have received at least 4 prior therapies and whose disease is refractory to at least 2 PIs, at least 2 IMiDs, and an anti-CD38 mAb5

    Patients responded to XPOVIO + dexamethasone within a median of 4 weeks1

    Graphic Graphic
    Patients stayed on XPOVIO treatment for a median of 8 weeks (range: 1-60 weeks)

    The primary endpoint of STORM Part 2 was overall response based on International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma1,6,7

    Progressive disease (PD)

    Evidence of increasing disease activity based on 25% increase from lowest response value in serum or urine M-protein; difference in involved and uninvolved free light chain (FLC) levels; bone marrow plasma cell percentage irrespective of baseline status; appearance of new lesions; and/or ≥50% increase in circulating plasma cells

    Stable disease (SD)

    Time-to-progression estimates. Stable disease does not meet criteria for responses identified below or for progressive disease

    Minimal response (MR)

    Relapsed refractory disease only. M-protein reduction of ≥25% but ≤49% and a 50%-89% reduction in 24-hour urine M-protein. A ≥50% reduction in the size of soft tissue plasmacytomas is also required if present at baseline

    Partial response (PR)

    Serum M-protein reduction ≥50% and a 24-hour urinary M-protein reduction by ≥90% or <200 mg per 24 hours. If unmeasurable, a ≥50% decrease in the difference between involved and uninvolved serum free light chain (sFLC) levels is required*

    Very good partial response (VGPR)

    Serum and urine M-protein levels detectable by immunofixation but not electrophoresis or serum M-protein reduction ≥90% and urine M-protein level <100 mg per 24 hours

    Complete response (CR)

    Negative immunofixation for serum and urine and disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow aspirates

    Stringent complete response (sCR)

    Complete criteria for CR and includes normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (κ/λ ratio ≤4:1 or ≥1:2 for κ and λ patients, respectively, ≥100 plasma cells)

    *If serum and urine M-protein and serum free light chain assay are unmeasurable, ≥50% reduction in plasma cells is required provided baseline bone marrow plasma cells were ≥30%. In addition,
    a ≥50% reduction in the size of soft tissue plasmacytomas is also required if present at baseline.

    Identifying patients eligible for treatment with XPOVIO

    Image of a patient classified as high-risk, rapidly progressing disease
    High-risk, rapidly progressing disease

    Disease information

    High-risk cytogenetics 1q21 gain and t(14;16)8,9

    Treatment course

    1st regimen5
    Carfilzomib + lenalidomide + dexamethasone followed by ASCT
    2nd regimen, maintenance5
    Bortezomib + lenalidomide + dexamethasone
    3rd regimen3,5
    Daratumumab + pomalidomide + dexamethasone
    4th regimen5
    Cyclophosphamide + carfilzomib + dexamethasone
    5th regimen1
    XPOVIO + dexamethasone
    Image of a patient with penta refractory relapsed refractory multiple myeloma
    Penta refractory RRMM

    Disease information

    Stage 1 IgG, transplant eligible, standard risk t(11;14)

    Treatment course

    1st regimen5
    Bortezomib + lenalidomide + dexamethasone followed by ASCT
    2nd regimen, maintenance5
    Lenalidomide + dexamethasone
    3rd regimen5,10
    Ixazomib + lenalidomide + dexamethasone
    4th regimen5
    Carfilzomib + lenalidomide + dexamethasone
    5th regimen5
    Daratumumab + pomalidomide + dexamethasone
    6th regimen1
    XPOVIO + dexamethasone

    ASCT=autologous stem cell transplant.

    Patient Profiles

    Review profiles of eligible patients

    Download

    References: 1. XPOVIO (selinexor) [package insert]. Newton, MA: Karyopharm Therapeutics Inc.; July 2019. 2. Gandhi UH, Senapedis W, Baloglu E, et al. Clinical implications of targeting XPO1-mediated nuclear export in multiple myeloma. Clin Lymphoma Myeloma Leuk. 2018;18(5):335-345. 3. Chari A, Vogl DT, Gavriatopoulou M, et al. Oral selinexor-dexamethasone for triple-class refractory multiple myeloma. N Engl J Med. 2019;381(8):727-738. 4. Data on file. Karyopharm Therapeutics Inc. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma. V.2.2020. © 2020 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed November 15, 2019. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. 6. Palumbo A, Rajkumar SV, San Miguel JF, et al. International Myeloma Working Group consensus statement for the management, treatment, and supportive care of patients with myeloma not eligible for standard autologous stem-cell transplantation. J Clin Oncol. 2014;32(6):587-600. 7. Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016;17(8):e328-e346. 8. Rajan AM, Rajkumar SV. Interpretation of cytogenetic results in multiple myeloma for clinical practice. Blood Cancer J. 2015;5:e365. 9. Sonneveld P, Avet-Loiseau H, Lonial S, et al. Treatment of multiple myeloma with high-risk cytogenetics: a consensus of the International Myeloma Working Group. Blood. 2016;127(24):2955-2962. 10. Sonneveld P, Broijl A. Treatment of relapsed and refractory multiple myeloma. Haematologica. 2016;101(4):396-406.