FDA approves selinexor for relapsed/refractory myeloma


  • David Reilly
  • Oncology drug update
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Takeaway

  • The US Food and Drug Administration (FDA) has approved selinexor in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM).
  • Selinexor is indicated for patients who have received ≥4 prior therapies and whose disease is resistant to several other forms of treatment, including ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-CD38 antibody.

Why this matters

  • Many patients eventually develop resistance to the most commonly used antimyeloma drugs currently available.
  • This is the first FDA approval in the selective inhibitor of nuclear export (SINE) class.

Study design

  • Phase 2b STORM study to investigate selinexor+dexamethasone in 83 patients refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab.
  • 65 (range, 40-86) years median patient age.
  • 81% had undergone prior stem cell transplantation.
  • 57% had high-risk cytogenetics.
  • Funding: Karyopharm Therapeutics Inc.

Key results

  • 25.3% (95% CI, 16.4%-36%) overall response rate (ORR).
  • 4 (range, 1-10) weeks median time to first response.
  • 3.8 months (95% CI, 2.3-not estimable) median duration of response.
  • Common hematologic adverse events (AEs) with selinexor+dexamethasone included leukopenia, neutropenia, thrombocytopenia, and anemia.
  • Other AEs included vomiting, nausea, fatigue, and hyponatremia.

Limitations

  • Accelerated approval; continued approval may be contingent upon confirmatory trial results.

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