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Selinexor, daratumumab, and dexamethasone in patients with relapsed or refractory multiple myeloma

Cristina Gasparetto1, Suzanne Lentzsch2, Gary Schiller3

  • 1Duke Cancer Institute School of Medicine Duke University Durham North Carolina.

Ejhaem
|July 18, 2022
PubMed

Insights

Selinexor, daratumumab, and dexamethasone (SDd) showed promise in treating relapsed refractory multiple myeloma (RRMM). The recommended dose of 100 mg once weekly selinexor was well-tolerated and effective in patients refractory to other treatments.

Area of Science:

  • Hematology
  • Oncology
  • Clinical Pharmacology

Background:

  • Relapsed refractory multiple myeloma (RRMM) presents a significant challenge, with limited treatment options for patients progressing after standard therapies.
  • Proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs) are mainstays of MM treatment, but resistance is common.
  • Novel therapeutic strategies are crucial for improving outcomes in heavily pretreated RRMM patients.

Purpose of the Study:

  • To evaluate the safety, efficacy, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) of selinexor in combination with daratumumab and dexamethasone (SDd) for RRMM.
  • To establish an optimal dosing regimen for this novel combination therapy.
  • To assess the tolerability and preliminary efficacy of a proteasome inhibitor- and immunomodulatory agent-free regimen.

Main Methods:

  • A phase 1/2 study enrolled 34 patients with RRMM, who had received a median of 3 prior therapies.
  • Patients received selinexor (100 mg once weekly or 60 mg twice weekly) combined with daratumumab and dexamethasone.
  • Dose-limiting toxicities (DLTs) were assessed to determine the MTD and RP2D. Overall response rate (ORR) and progression-free survival (PFS) were evaluated.

Main Results:

  • The 100 mg once-weekly dose of selinexor was identified as the MTD and RP2D, with no DLTs observed in this cohort.
  • The most common treatment-related adverse events included thrombocytopenia (70.6%), nausea (70.6%), fatigue (61.8%), anemia (61.8%), and neutropenia (50.0%).
  • An overall response rate of 73% and a median progression-free survival of 12.5 months were observed in daratumumab-naïve patients.

Conclusions:

  • The selinexor, daratumumab, and dexamethasone (SDd) combination is well-tolerated and demonstrates promising efficacy in patients with relapsed refractory multiple myeloma.
  • The recommended phase 2 dose is 100 mg of selinexor once weekly.
  • This proteasome inhibitor- and immunomodulatory agent-free regimen warrants further investigation in RRMM patients, particularly those naïve to daratumumab after prior PI and IMiD therapy.
Keywords:
DaratumumabMultiple MyelomaSelinexor

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