How is XPOVIO used?

XPOVIO is used in combination with dexamethasone (Sd) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) 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.

What types of patients can benefit from XPOVIO?

In a phase 2 clinical trial, XPOVIO (in combination with dexamethasone) was shown to be effective in:

• Patients who received at least 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?

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.

What are XPOVIO side effects?

The most common side effects seen in a clinical study with Sd 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

In this study, the most common serious side effects included:

• Low platelet counts (thrombocytopenia)

• Low numbers of white blood cells known as neutrophils (neutropenia)

• Gastrointestinal
• Low sodium levels (hyponatremia)
• Neurological
• Embryo-fetal toxicity

What have XPOVIO clinical trials shown?

The approval of XPOVIO was based on results from the STORM trial, a phase 2 trial to determine the efficacy of XPOVIO combined with dexamethasone (Sd) in patients with RRMM.

• The study included 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 Sd treatment was seen in 21% of patients.

How is XPOVIO currently being studied in myeloma?

XPOVIO is being evaluated in several clinical trials in the U.S.

• In combination with Velcade (bortezomib, Takeda Oncology) and dexamethasone for patients with relapsed/refractory myeloma (BOSTON trial; NCT03110562)
• 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 Ninlaro (ixazomib, Takeda Oncology) and dexamethasone for patients with relapsed/refractory myeloma (NCT02831686)
• In combination with high-dose melphalan before autologous stem cell transplantation for patients with newly diagnosed myeloma (NCT02780609)

Interested in learning more about XPOVIO clinical trials? Talk to an MMRF Nurse Patient Navigator  to learn more or use our clinical trials finder:

FIND CLINICAL TRIALS

Created July 2019

Please visit the sponsor’s official patient site for up-to-date information on XPOVIO.