What is XPOVIO®?
XPOVIO, also known as selinexor, is a first-in-class oral selective inhibitor of nuclear The MMRF played a role in the development of XPOVIO, and the Multiple Myeloma Research Consortium (MMRC) is currently facilitating clinical trials evaluating its use in combination with other myeloma agents.
export (SINE). XPOVIO is manufactured by Karyopharm Therapeutics.

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How is XPOVIO used?
For the treatment of patients with relapsed or refractory multiple myeloma (RRMM), XPOVIO is approved for use in the following ways:- In combination with dexamethasone (Xd) for patients who have received at least four prior antimyeloma treatment regimens and are refractory to at least two proteasome inhibitors, at least two immunomodulatory drugs, and an anti-CD38 monoclonal antibody
- In combination with Velcade (bortezomib, Takeda Oncology) and dexamethasone (XVd) for patients who have received at least 1 prior therapy
What types of patients can benefit from XPOVIO?
XPOVIO (in combination with dexamethasone with or without Velcade) was shown to be effective in:- Patients who received at least one to four prior therapies
- Patients who were refractory to their previous treatment(s)
- Patients who previously received high-dose chemotherapy and stem cell transplant
How does XPOVIO work?
XPOVIO binds to and inhibits the nuclear export protein XPO1, leading to the accumulation of tumor-suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells while largely sparing normal cells.How is XPOVIO administered?
In the Xd regimen, XPOVIO is given orally at a dose of 80 mg along with dexamethasone (20 mg orally) twice a week (both drugs on days 1 and 3 of a 28-day cycle) until disease progression.In the XVd regimen, XPOVIO is given orally at a dose of 100 mg once a week on day 1 of each week with dexamethasone (20 mg orally) twice a week (on days 1 and 2 of each week) and Velcade (1.3 mg/m 2 subcutaneously) once a week on day 1 of each week for four weeks followed by one week off until disease progression.
What are XPOVIO side effects?
In clinical studies the most common side effects seen with XPOVIO included:- Low platelet counts (thrombocytopenia)
- Fatigue
- Nausea
- Anemia
- Decreased appetite
- Decreased weight
- Diarrhea
- Vomiting
- Low sodium levels (hyponatremia)
- Low numbers of white blood cells known as neutrophils (neutropenia)
- Low numbers of white blood cells overall (leukopenia)
- Constipation
- Shortness of breath
- Upper respiratory tract infection
- Cataract
- Low platelet counts (thrombocytopenia)
- Low numbers of white blood cells known as neutrophils (neutropenia)
- Gastrointestinal
- Low sodium levels (hyponatremia)
- Neurological
- Embryo-fetal toxicity
How are side effects of XPOVIO managed?
Blood tests and body weight are monitored at baseline and during treatment as needed, with more frequent monitoring during the first three months of treatment. Patients should maintain appropriate fluid and caloric intake throughout their treatment.What have XPOVIO clinical trials shown?
The efficacy of XPOVIO in combination with dexamethasone (Xd) in RRMM patients was based on results from the STORM trial, a phase 2 trial of 122 patients, 83 of whom had received at least four prior antimyeloma treatment regimens and were refractory to at least two proteasome inhibitors, at least two immunomodulatory drugs, and an anti- CD38 monoclonal antibody. Response to Xd treatment was seen in 25% of patients.The efficacy of XPOVIO in combination with Velcade-dexamethasone in patients with RRMM was shown in a phase 3 clinical trial (BOSTON), in which 402 patients participated. All patients received Vd; one half of the patients also received XPOVIO (XVd).
The BOSTON study showed the following:
- Treatment with XVd resulted in a 30% reduction in the risk of death or disease progression and this benefit was also seen across various subgroups including patients older than 65 years, patients who are frail, patients with high-risk cytogenetic abnormalities, and patients who had previously received Revlimid (lenalidomide, Bristol Myers Squibb) therapy.
How is XPOVIO currently being studied in myeloma?
XPOVIO is being evaluated in several clinical trials in the U.S.- In combination with backbone treatments for patients with relapsed/refractory myeloma (STOMP trial; NCT02343042)
- In combination with Kyprolis (carfilzomib, Amgen) and dexamethasone for patients with relapsed/refractory myeloma (SINE trial; NCT02199665)
- In combination with Kyprolis, Darzalex (daratumumab, Janssen), or Pomalyst (pomalidomide, Bristol Myers Squibb) in patients with myeloma (NCT04661137)
- In combination with Ninlaro (ixazomib, Takeda Oncology) and dexamethasone for patients with relapsed/refractory myeloma (NCT02831686)
FIND CLINICAL TRIALS
Updated December 2020
Please visit the sponsor’s official patient site for up-to-date information on XPOVIO.