Xpovio - Selinexor Approved by FDA for the Treatment of Multiple Myeloma

Cancer Connect

by Dr. C.H. Weaver M.D. updated 12/2020

The FDA granted accelerated approval to Xpovio (selinexor) for use in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma in July 2019 based on the multi-center, single-arm Phase 2b STORM (Selinexor Treatment of Refractory Myeloma) study in approximately 122 patients with heavily pretreated, penta-refractory multiple myeloma. Researchers have subsequently determined more effective treatment combinations with Xpovio.

About Xpovio - Selinexor

Xpovio (selinexor-KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Xpovio functions by binding with and inhibiting 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.

This initial approval was based on data from a study that evaluated the effectiveness of the combination therapy in 83 patients with relapsed or refractory multiple myeloma. Overall 25.3% of patients responded to Xpovio and the median duration of response was 3.8 months.

Weekly Xpovio, Velcade (bortezomib) and Dexamethasone Improves Outcomes in MM

Once weekly Xpovio, Velcade, and dexamethasone (SVd) significantly delays myeloma progression compared to standard twice weekly Velcade and dexamethasone (Vd) for multiple myeloma according to results from the BOSTON study presented at the virtual 2020 ASCO Annual Meeting. (3)

The randomized, phase 3 BOSTON study evaluated once weekly SVd compared with twice weekly Vd for patients who received 1-3 prior anti-MM therapies in 402 patients with multiple myeloma. The average time to myeloma progression was ~14 months with SVd compared to 9.5 months with Vd and average survival duration exceeds the 25 months reported for Vd.

The most common side effects reported were thrombocytopenia fatigue and nausea. Importantly peripheral neuropathy was significantly less with SVd compared with Vd.

A once weekly regimen of Xpovio plus Velcade and dexamethasone could be a new standard and convenient therapy for patients with MM,

References:

  1. Market News
  2. Food and Drug Administration. FDA approves new treatment for refractory multiple myeloma.](https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-refractory-multiple-myeloma). Accessed July 03, 2019.
  3. Dimopoulos M, Delimpasi S, Simonova M, et al. Weekly selinexor, bortezomib, and dexamethasone (SVd) versus twice weekly bortezomib and dexamethasone (Vd) in patients with multiple myeloma (MM) after one to three prior therapies: Initial results of the phase III BOSTON study. Presented at: the 2020 ASCO Annual Meeting; May 29-31, 2020. Abstract 8501.
https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-refractory-multiple-myeloma).
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