ASH 2018 — Selinexor yields 26% ORR in highly refractory MM


  • Wayne Kuznar
  • Univadis
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Takeaway

  • Selinexor plus low-dose dexamethasone induces response for 1 in 4 patients with multiple myeloma (MM) who are refractory to multiple lines of prior therapy.

Why this matters

  • The oral exportin 1 (XPO1) inhibitor is the first investigational drug to show activity in this patient population. 
  • Expected median OS in heavily pretreated patients with disease progression is only ~1.7 months, and there are currently no therapies with clinical benefit in triple class refractory MM.

Study design

  • STORM Part 2 study, a single-group trial of 122 patients (median age, 65 years) with MM previously treated with bortezomib, carfilzomib, lenalidomide, pomalidomide, daratumumab, an alkylator, and/or glucocorticoids. 
  • 100% were quad-refractory; 68% were penta-refractory (including anti-CD38 agent); and 96% were refractory to all 3 drug classes represented by carfilzomib, pomalidomide, and daratumumab.
  • Median number of prior regimens, 7 (over the course of 6.6 years).
  • 29.5% received ≥9 prior lines.
  • Selinexor (80 mg)+dexamethasone (20 mg) was administered twice weekly on days 1 and 3 of a 28-day cycle.
  • Funding: Karyopharm

Key results

  • Overall response rate, 26.2%.
    • 19.7% with very good partial response (PR).
    • 6.5% with very good or better PR, including 2 patients with stringent complete responses.
  • Median PFS, 3.7 months (5.3 months in patients with at least a PR).
  • Median OS, 8.6 months (15.6 months in patients with at least a minimal response).
  • 79.7% required dose modification because of adverse events (AEs), mostly during the first 2 cycles.
  • Two patients with progression after CAR-T therapy had a PR.
  • Nonhematologic AEs included nausea (69.1%), fatigue (56.1%), and anorexia (52.0%).
  • Hematologic AEs included thrombocytopenia (67.5%), anemia (48.0%), neutropenia (36.6%), and leukopenia (29.3%).

Limitation

  • Single-group study.

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