A phase 1/2 study showed that iberdomide, daratumumab, and dexamethasone (IBERDd) had a manageable safety profile when used in transplant-ineligible, newly diagnosed multiple myeloma (MM).
The study was presented by Abdullah Mohammad Khan, MBBS, of The Ohio State University Comprehensive Cancer Center, as part of the SOHO 2025 Annual Meeting.
Initial data from the CC-220-MM-001 trial showed activity and tolerability of this combination in a relapsed or refractory MM population.
This analysis assessed 75 untreated patients (median age, 75 years) who were not recommended for transplant due to age or comorbidities. Patients received IBER at 1.0, 1.3, and 1.6 mg doses (n=25 per dose level) plus subcutaneous daratumumab 1,800 mg and oral dexamethasone 40 mg (20 mg if older than 75 years).
Most patients (56%) were men, and 41.3% had high-risk cytogenetics.
After a median follow-up of 13.9 months, IBERDd resulted in an overall response rate of 94.7%, including 86.7% achieving a very good partial response (VGPR) or better and 57.3% achieving a complete response or better.
Among patients who achieved a VGPR or better (n=65), the measurable residual disease-negativity rate at 10−5 was 43.1%. Median time to response was 1 month.
Grade 3/4 treatment-emergent adverse events occurred in nearly all patients (94.7%), most commonly neutropenia (n=56; 74.7%). Grade 3/4 infections occurred in 38.7% patients.
IBER dose interruptions or reductions due to adverse events occurred in 80.0% and 37.3% of patients, respectively.
As of May 29, 2024, 62 patients (82.7%) continued on this treatment.
The study indicated maximal pharmacodynamic activity at the IBER 1.0 mg dose.
“Preliminary data on IBERDd in [transplant-ineligible, newly diagnosed] MM show notable efficacy and a manageable safety profile and no new safety signals across all [three] IBER doses,” the authors concluded.
Reference
Balari AS, Khan AM, Oriol A, et al. Iberdomide (IBER), daratumumab (DARA), and dexamethasone (DEX) (IberDd) in transplant-ineligible (TNE) newly diagnosed multiple myeloma (NDMM): results from the phase 1/2 CC-220-MM-001 trial. Abstract #MM-101. Presented at the Society of Hematologic Oncology 2025 Annual Meeting; September 3-6, 2025; Houston, Texas.
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