XPOVIO was studied in combination with Vd in the XVd trial1

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The XVd trial was a phase 3, global, randomized, open-label study of adult patients with MM who had received 1 to 3 prior therapies that compared XPOVIO + Vd with Vd1,2

XVd study design schema showing how XVd was studied compared to Vd in the XVd clinical trial XVd study design schema showing how XVd was studied compared to Vd in the XVd clinical trial

Primary endpoint1,2:

  • PFS

Select secondary endpoints1,2:

  • Overall response rate
  • Very good partial response or above
  • Grade ≥2 peripheral neuropathy
  • Overall survival
  • Duration of response
  • Time to next therapy
  • Safety and tolerability

The trial included patients with a broad range of characteristics, including1:

High-risk
cytogenetics

Renal
impairment

Age
≥65 Years

Prior anti-CD38
mAb exposure

Demographic
XVd
(n=195)
Vd
(n=207)
Median age, years
66 (40,87)
67 (38,90)
Age distribution, n (%)
<65 years
65-74 years
≥75 years

86 (44)
75 (38)
34 (17)

75 (36)
85 (41)
47 (23)
Sex, n (%)
Male
Female

115 (59)
80 (41)

115 (56)
92 (44)
Characteristic
XVd
(n=195)
Vd
(n=207)
Median years from diagnosis to randomization (range)
3.81 (0.4-23.0)
3.59 (0.4-22.0)
ECOG performance status score, n (%)
0-1
≥2

175 (90)
20 (10)

191 (92)
16 (8)
Creatinine clearance (mL/min), n (%)
<30
30-59
≥60

3 (1.5)
53 (27)
139 (71)

10 (5)
60 (29)
137 (66)
Revised international staging system at baseline, n (%)
I
II
III
Unknown

56 (29)
117 (60)
12 (6)
10 (5)

52 (25)
125 (60)
16 (8)
14 (7)
Number of prior therapies, n (%)
1
2
3

99 (51)
65 (33)
31 (16)

99 (48)
64 (31)
44 (21)
Type of known prior therapy, n (%)
Stem cell transplantation
Lenalidomide
Pomalidomide
Bortezomib
Carfilzomib
Daratumumab

76 (39)
77 (39)
11 (6)
134 (69)
20 (10)
11 (6)

63 (30)
77 (37)
7 (3)
145 (70)
21 (10)
6 (3)
Known high-risk cytogenetics, n (%)
Includes any of del(17p)/p53, t(14;16), t(4;14), 1q21

97 (50)

95 (46)
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XVd Trial Results

View the results of the XVd trial, including efficacy observed in certain subgroups.

Abbreviations: ECOG, Eastern Cooperative Oncology Group; IRC, independent review committee; mAb, monoclonal antibody; MM, multiple myeloma; PFS, progression-free survival; PO, by mouth; RRMM, relapsed or refractory multiple myeloma; SC, subcutaneous; Vd, bortezomib and dexamethasone; Xd, selinexor and dexamethasone; XVd, selinexor, bortezomib, and dexamethasone.

References: 1. XPOVIO (selinexor) [prescribing information]. Newton, MA. Karyopharm Therapeutics, Inc. 2. Grosicki S, Simonova M, Spicka I, et al. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial. Lancet. 2020;396(10262):1563-1573. doi:10.1016/S0140-6736(20)32292-3

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INDICATION

XPOVIO® (selinexor) is a prescription medicine approved in combination with bortezomib and dexamethasone (XVd) to treat adult patients with multiple myeloma who have received at least one prior therapy.

IMPORTANT SAFETY INFORMATION

Thrombocytopenia: XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia was reported in patients with multiple myeloma.

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. Monitor patients for signs and symptoms of bleeding. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction.

Neutropenia: XPOVIO can cause life-threatening neutropenia, potentially increasing the risk of infection.

Monitor more frequently during the first 3 months of treatment. Consider supportive measures, including antimicrobials and growth factors (e.g., G-CSF). Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction.

Gastrointestinal Toxicity: XPOVIO can cause severe gastrointestinal toxicities in patients.

Nausea/Vomiting/Diarrhea: Provide prophylactic antiemetics or treatment as needed.

Anorexia/Weight Loss: Monitor weight, nutritional status, and volume status at baseline and throughout treatment and provide nutritional support, fluids, and electrolyte repletion as clinically indicated.

Hyponatremia: XPOVIO can cause severe or life-threatening hyponatremia.

Monitor sodium level at baseline and throughout treatment.

Serious Infection: XPOVIO can cause serious and fatal infections. Atypical infections reported after taking XPOVIO include, but are not limited to, fungal pneumonia and herpesvirus infection.

Neurological Toxicity: XPOVIO can cause life-threatening neurological toxicities.

Coadministration of XPOVIO with other products that cause dizziness or mental status changes may increase the risk of neurological toxicity.

Advise patients to refrain from driving and engaging in hazardous occupations or activities, until the neurological toxicity fully resolves. Institute fall precautions as appropriate.

Embryo-Fetal Toxicity: XPOVIO can cause fetal harm when administered to a pregnant woman.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.

Cataracts: New onset or exacerbation of cataract has occurred during treatment with XPOVIO. The incidence of new onset or worsening cataract requiring clinical intervention was reported.

ADVERSE REACTIONS

The most common adverse reactions (ARs) (≥20%) in patients with multiple myeloma who received XVd were fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract, and vomiting.

Grade 3-4 laboratory abnormalities (≥10%) were thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia.

Fatal ARs occurred in 6% of patients within 30 days of last treatment. Serious ARs occurred in 52% of patients. Treatment discontinuation rate due to ARs was 19%. The most frequent ARs requiring permanent discontinuation in >2% of patients included fatigue, nausea, thrombocytopenia, decreased appetite, peripheral neuropathy and vomiting. Adverse reactions led to XPOVIO dose interruption in 83% of patients and dose reduction in 64% of patients.

USE IN SPECIFIC POPULATIONS

No overall difference in effectiveness of XPOVIO was observed in patients >65 years old when compared with younger patients. Patients ≥65 years old had a higher incidence of discontinuation due to an adverse reaction (AR) and a higher incidence of serious ARs than younger patients.

The effect of end-stage renal disease (CLCR <15 mL/min) or hemodialysis on XPOVIO pharmacokinetics is unknown.

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1-888-209-9326 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

© 2023 Karyopharm Therapeutics Inc.

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