XPOVIO® (selinexor) | RR DLBCL Treatment Response Rate With XPOVIO® (selinexor)

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How did patients respond to
treatment with XPOVIO^® (selinexor)?

In the clinical trial, 134 adults with relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL) were treated with XPOVIO 60 mg on Days 1 and 3 of every week. The FDA approval was based upon the results of this trial, and additional trials may be needed.

Chart showing XPOVIO® response rate

Response to XPOVIO was evaluated in patients regardless of status (n=39):

Their age
The number of treatments they had taken before
The type of diffuse large B-cell lymphoma (DLBCL) they have
If their DLBCL had stopped responding to other treatments
If they had previously had a stem cell transplant

XPOVIO has been shown to work when taken by itself in patients with RR DLBCL.
Patients who responded did not need to take XPOVIO with another anti‑cancer medicine.

How long did responses to XPOVIO last?

Patients who responded to XPOVIO had a rapid and meaningful response.

Chart showing overall response rate

Chart showing overall response rate

*The median duration of response (DOR) was a prespecified secondary outcome, determined by a particular statistical analysis. Limitations to this analysis for the data from this study include a small number of patients and the effect of data from patients with prolonged remission durations. Approximately half of the responders in this analysis had a DOR lasting less than 3 months.

The analysis of DOR is presented alongside an analysis demonstrating the number of patients responding at certain timepoints (3, 6, 12 months).

The median number is the middle point of a set of numbers, in which half the numbers are above the median and half are below.

Side Ef‌fects

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Taking XPOVIO

See the recommended dosing schedule

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Patient & Caregiver Support

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support and resources

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What is XPOVIO?

XPOVIO^® (selinexor) is a prescription medicine used:

in combination with bortezomib and dexamethasone (XVd) to treat adult
patients with multiple myeloma who have received at least one prior
therapy.

Your healthcare provider will do blood tests before you start taking XPOVIO, and often during the first 3 months of treatment, and then as needed during treatment.

XPOVIO can cause serious side effects, including:

Low platelet counts. Low platelet counts are common with XPOVIO and can lead to bleeding, which can be severe and can sometimes cause death.

What is XPOVIO?

XPOVIO^® (selinexor) is a prescription medicine used:

in combination with bortezomib and dexamethasone to treat adults with multiple myeloma who have received at least one prior therapy.
in combination with dexamethasone to treat adults with multiple myeloma that has come back (relapsed) or that did not respond to previous treatment (refractory), and
- who have received at least 4 prior therapies, and
- whose disease did not respond (refractory) to at least 2 proteasome inhibitor medicines, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody medicine

XPOVIO is approved based on patient response rate. There are ongoing studies to confirm the clinical benefit of XPOVIO for the following use:

to treat adults with certain types of dif‌fuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory) and who have received at least 2 prior systemic therapies

It is not known if XPOVIO is safe and effective in children less than 18 years of age.

Your healthcare provider will do blood tests before you start taking XPOVIO, and often during the first 3 months of treatment, and then as needed during treatment.

XPOVIO can cause serious side ef‍fects, including:

Low platelet counts. Low platelet counts are common with XPOVIO and can lead to bleeding, which can be severe and can sometimes cause death. Your healthcare provider may prescribe platelet transfusions or other treatments for your low platelet counts.
Tell your healthcare provider right away if you have any bleeding or easy bruising during treatment with XPOVIO.
Low white blood cell counts. Low white blood cell counts are common with XPOVIO and can sometimes be severe. You may have an increased risk of getting bacterial infections during treatment with XPOVIO. If needed, your healthcare provider may prescribe antibiotics if you have signs or symptoms of infection.
Serious infections. Infections are common with XPOVIO and can be serious and can sometimes cause death. This includes upper or lower respiratory tract infections, such as pneumonia, and an infection throughout your body (sepsis). Tell your healthcare provider right away if you have any signs or symptoms of an infection such as cough, chills, or fever during treatment with XPOVIO.
Neurologic side ef‌fects. XPOVIO can cause dizziness, fainting, decreased alertness, and changes in your mental status, including problems with thinking, seeing or hearing things that are not really there (hallucinations). These problems can sometimes be severe and life-threatening. Tell your healthcare provider right away if you get any of these symptoms. Do not drive or operate heavy or dangerous machinery until you know how XPOVIO affects you. Take precautions to prevent a fall.
Nausea, vomiting and/or diarrhea. Nausea, vomiting and/or diarrhea can occur when you take XPOVIO and can sometimes be severe. You may be at risk for becoming dehydrated. Your healthcare provider may prescribe anti-nausea or anti-diarrhea medicines.
Loss of appetite and weight loss. Loss of appetite and weight loss are common with XPOVIO. Tell your healthcare provider if you have a decrease or loss of appetite and if you are losing weight.
Decreased sodium levels in your blood. Decreased sodium levels in your blood are common with XPOVIO. Your healthcare provider may talk with you about your diet and prescribe IV fluids or salt tablets.
New or worsening cataract, cloudiness or loss of transparency of the lens in the eye. New or worsening cataract are common with XPOVIO. If a cataract forms, your vision may decrease, and you may need eye surgery to remove the cataract and restore your vision. Tell your healthcare provider right away if you have symptoms of a cataract such as double vision, blurred vision, or sensitivity to light or glare.

Common side ef‌fects of XPOVIO include:

tiredness
low red blood cell count (anemia). Symptoms may include tiredness and shortness of breath
constipation
shortness of breath
increased blood sugar
changes in body salt and mineral levels in your blood
changes in kidney and liver function blood tests

These are not all of the possible side effects of XPOVIO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1‑800‑FDA‑10881‑800‑FDA‑1088.

Before taking XPOVIO, tell your healthcare provider about all of your medical conditions, including if you:

have or have had a recent or active infection
have or have had bleeding problems
are pregnant or plan to become pregnant. XPOVIO can harm your unborn baby
are taking prescription and over-the-counter medicines, vitamins, and herbal supplements

Ability to have children: XPOVIO may af‌fect the ability of both women and men to have children. Talk to your healthcare provider if you have concerns about fertility.

Females who are able to become pregnant: Your healthcare provider will check to see if you are pregnant before you start taking XPOVIO. You should use ef‌fective birth control (contraception) during treatment with XPOVIO and for 1 week af‌ter your last dose, as XPOVIO can harm an unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with XPOVIO. Do not breastfeed during treatment with XPOVIO and for 1 week after your last dose of XPOVIO. It is not known if XPOVIO passes into your breast milk.

Males with female partners who are able to become pregnant should use ef‌fective birth control during treatment with XPOVIO and for 1 week af‌ter your last dose.

Please see the Medication Guide and the full Prescribing Information for XPOVIO.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‑888‑209‑93261‑888‑209‑9326 or FDA at 1‑800‑FDA‑10881‑800‑FDA‑1088 or www.fda.gov/medwatch.

© 2023 Karyopharm Therapeutics Inc.