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On Sunday 16 June at the 24th Congress of the European Hematology Association (EHA), Darrell White, Dalhousie University, Nova Scotia, CN, on behalf of Christina Gasparetto, Duke University Cancer Center, North Carolina, US, presented a phase Ib/II trial on selinexor (S), daratumumab (D), and dexamethasone (d; SDd) in patients with relapsed or refractory multiple myeloma (RRMM).1
Selinexor is a first-in-class selective inhibitor of exportin-1 (XPO1), which is involved in nuclear protein exportation and is found in myeloma cells. Pre-clinical evidence indicates that selinexor blocks the translation of oncoproteins and that it works synergistically with dexamethasone to induce cytotoxicity in vitro2 and in heavily-pretreated MM patients.3
The primary objectives of this multicenter, open-label study were the determination of the maximum tolerated dose and recommended SDd phase II dose, as well as safety and preliminary SDd efficacy in patients with RRMM.
Table 1. Key baseline characteristics:
ASCT, autologous stem cell transplant; IMiDs, immunomodulatory drugs; PIs, proteasome inhibitors; SDd, Selinexor, daratumumab and dexamethasone |
|
Baseline characteristic |
Patient cohort (N=34) |
---|---|
Median age (range) |
68 (44–83) |
Male patients |
56% |
Median time from diagnosis to SDd treatment (range) |
5.6 (<1–14) |
Median number of prior lines (range): Treated: Refractory to PIs Treated: Refractory to IMiDs ASCT Daratumumab treated |
3 (2–10) 100%:85% 100%:76% 71% 6% |
Table 2. Preliminary efficacy outcomes:
MR, minimal response; ORR, overall response rate; PD, progressive disease; PR, partial response; SD, stable disease; VGPR, very good partial resonse |
||
|
Daratumumab-naïve patients (n=30) |
Total cohort (n=32) |
---|---|---|
ORR |
73% |
69% |
VGPR |
37% |
34% |
PR |
37% |
34% |
MR |
13% |
13% |
Clinical benefit rate (ORR+MR) |
86% |
81% |
SD |
13% |
16% |
PD |
- |
3% |
The recommended phase II SDd dose for the treatment of RRMM patients was 100mg of selinexor, 16mg/kg daratumumab plus 40mg dexamethasone, administered once a week. No DLTs occurred at this dose level and the safety profile was tolerable and manageable. Preliminary efficacy outcomes indicate that SDd treatment leads to deep and durable responses in RRMM patients with an ORR of 73% in daratumumab-naïve patients and 69% in the total cohort.
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