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IberDd for transplant-ineligible patients with NDMM: Results from the phase I/II CC-220-MM-001 trial
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The open-label, multicenter, phase I/II CC-220-MM-001 trial (NCT02773030) is evaluating iberdomide, an oral CELMoD, as a monotherapy and in combination with several different regimens in patients with multiple myeloma.1 Cohort K (n = 75) in the phase II dose-expansion portion of this trial investigated IberDd as a treatment for adult patients with NDMM who are TI or not receiving auto-HSCT as their first therapy. Results from cohort K of this trial were presented at the 21st IMS Annual Meeting by Rodríguez-Otero.1 |
| Key learnings |
| The ORR, ≥CR, and ≥VGPR rates were 94.7%, 57.3%, and 86.7%, respectively. Among patients with a ≥VGPR, the MRD negativity rate was 43.1%. The median time to first response was 1.0 months and the median DOR was not reached. |
| Responses deepened over time, with a ≥CR rate of 22.7%, 44.0%, and 57.3% after a median of 7, 11, and 14 months, respectively. |
| Treatment was well tolerated, with no new safety signals observed. The most common Grade ≥3 hematologic TEAE was neutropenia (34.7%), primarily occurring in the first two cycles of therapy. The most common non-hematologic Grade ≥3 TEAE was infections (38.7%). |
| In total, 17.3% of patients discontinued treatment. Three patients died due to TEAEs, with no deaths attributed to study treatment. |
| The high rates of rapid and deep responses and manageable safety profile support further evaluation of the IberDd regimen in TI patients with NDMM. Abbreviations: BCMA, B-cell maturation agent; CAR, chimeric antigen receptor; CRS, cytokine release syndrome; DLT, dose-limiting toxicity; GvHD, graft-versus-host disease; HLH, hemophagocytic lymphohistiocytosis; ICANS, immune effector cell-associated neurotoxicity syndrome; IMS, International Myeloma Society; MAS, macrophage activation syndrome; RRMM, relapsed/refractory multiple myeloma. |
Abbreviations: auto-HSCT, autologous hematopoietic stem cell transplantation; CELMoD, cereblon E3 ligase modulatory drugs; CR, complete response; DOR, duration of response; IMS, International Myeloma Society; IberDd, iberdomide, daratumumab, and dexamethasone; MRD, measurable residual disease; NDMM, newly diagnosed multiple myeloma; ORR, overall response rate; TEAE, treatment-emergent adverse event; TI, transplant-ineligible; VGPR, very good partial response.
References
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