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    SADAL: a multicenter, single-arm, open-label study of XPOVIO® (selinexor) monotherapy for adult patients with relapsed or refractory diffuse large B‑cell lymphoma (RR DLBCL)1

    Study design

    • Study population: Patients with RR DLBCL, NOS, who had received 2 to 5 systemic regimens and were not eligible for autologous HSCT
    • Dosing: XPOVIO 60 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity
    • Primary endpoint: Overall response rate (ORR)

    Baseline patient characteristics (N=134)1


    Median age icon

    Median age: 67 years
    (range: 35-91)

    ≥65 YEARS: 61%
    ≥75 YEARS: 25%

    MALE: 59%
    FEMALE: 41%

    Median time from progression to start of XPOVIO therapy:
    7.3 weeks

    Median time from last systemic therapy to start of XPOVIO:
    5.4 months
    (3.6 months in patients with refractory disease)

    ECOG performance status score icon

    ECOG performance
    status score1



    0 OR 1: 88%

    CLcr (mL/minute) icon

    CLCR
    (mL/minute)2


    <30: 2.2%
    30-<60: 25.4%
    ≥60: 72.4%

    R-IPI icon


    R-IPI2


    VERY GOOD (0): 2.2%
    GOOD 1, 2: 49.3%
    POOR 3, 4, 5: 43.3%
    MISSING: 5.2%

    CLCR=creatinine clearance, ECOG=Eastern Cooperative Oncology Group, HSCT=hematopoietic stem cell transplantation, NOS=not otherwise specified, R-IPI=revised International Prognostic Index.

    Single-agent XPOVIO was studied in one of the largest clinical trials of adult patients with RR DLBCL, a population with diverse disease characteristics1

    Baseline disease characteristics (N=134)1

    De novo DLBCL NOS
    Transformed DLBCL
    75%
    23%
    GCB
    Non-GCB
    Not classified
    47%
    49%
    4%
    Double/triple expressor 20%
    Median prior systemic therapies
    • 2 prior systemic therapies
    • 3 prior systemic therapies
    • 4 or 5 prior systemic therapies
    2 (range: 1- 5)
    63%
    24%
    10%
    Prior autologous HSCT 30%
    Disease refractory to most recent therapy 28%
    Disease relapse <1 year after first anti-DLBCL treatment 53%
    Disease relapse <1 year following autologous HSCT 17%

    GCB=germinal center B cell.

    53% of patients had progressed in <1 year after receiving their
    first treatment, and 30% had received prior autologous HSCT1

    In adult patients with RR DLBCL who had received ≥2 prior therapies,

    Single-agent, oral XPOVIO delivered clinically significant responses

    Graphic showing overall response rate Graphic showing overall response rate
    50% of responses to XPOVIO were evident at the time of the first disease assessment
    (median time to first response: 1.9 months)1✝
    • Responses were assessed by an Independent Radiologic Review Committee (IRC) using Lugano 2014 criteria
    • Response to XPOVIO was not impacted by patient status2

    Selinexor (XPOVIO) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) with a category 2A recommendation as a ≥3-line treatment option for patients with RR DLBCL who have received ≥2 prior lines of systemic therapy, including patients with disease progression after transplant or CAR T-cell therapy.3

    *Includes CR + PR.

    The first clinical evaluation was conducted at 8 weeks.

    Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-cell lymphomas. V.4.2020. © 2020 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed August 14, 2020. 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.3

    ASCT=autologous stem cell transplantation, CAR=chimeric antigen receptor, CI=confidence interval, CR=complete response, PR=partial response, SD=stable disease.

    In adult patients with RR DLBCL who had received ≥2 prior therapies,

    Responses achieved with XPOVIO were rapid and clinically meaningful

    Percentage of patients (N=39) who still had a response at 3, 6, and 12 months

    Graphic showing XPOVIO® (selinexor) response rates Graphic showing XPOVIO® (selinexor) response rates

    *The median DOR was determined using a prespecified secondary Kaplan-Meier (K-M) analysis. Limitations to this analysis include small patient numbers and the effect of outliers with prolonged remission durations. Approximately half of the responders in this analysis had a DOR lasting <3 months.

    The K-M analysis of DOR is presented alongside an analysis demonstrating the number of patients responding at a certain timepoint (3, 6, 12 months).

    References: 1. XPOVIO (selinexor) [package insert]. Newton, MA: Karyopharm Therapeutics Inc.; June 2020. 2. Data on file. Karyopharm Therapeutics Inc. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas. V.4.2020. © 2020 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed August 14, 2020. 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.

    INDICATIONS

    • XPOVIO® (selinexor) in combination with dexamethasone is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody.
    • XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

    IMPORTANT SAFETY INFORMATION

    Thrombocytopenia: XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia was reported in patients with multiple myeloma (MM) and developed or worsened in patients with DLBCL.

    Thrombocytopenia is the leading cause of dosage modifications. Monitor platelet counts at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction.