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DREAMM-9 updated interim analysis: Belantamab mafodotin in combination with SoC in transplant-ineligible NDMM
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Belantamab mafodotin (belamaf) is a first-in-class BCMA-directed ADC currently under evaluation as a single agent and in combination with other treatments in R/R and NDMM in the DREAMM clinical trial program.1 DREAMM-9 (NCT04091126) is an ongoing randomized phase I dose optimization study investigating belamaf in combination with VRd in patients with TI NDMM (N = 108).1 The trial includes eight cohorts (C1–8) with differing belamaf doses, schedules, and follow-up: C1, 1.9 mg/kg Q3/4W (n = 12); C2, 1.9 mg/kg Q6/8W (n = 12); C3, 1.4 mg/kg Q3/4W (n = 13); C4, 1.4 mg/kg Q6/8W (n = 12); C5, 1.9 mg/kg for 1 dose and then 1.4 mg/kg Q9/12W (n = 19); C6, 1.0 mg/kg Q3/4W (n = 15); C7, 1.4 mg/kg for 1 dose and then 1.0 mg/kg Q9/12W (n = 15); C8, 1.0 mg/kg Q12W (n = 10).1 An updated interim analysis of data across all cohorts from the DREAMM-9 trial was presented by Usmani at the 66th ASH Annual Meeting and Exposition.1 |
| Key learnings |
| ORRs ranged from 71–100%, with a 100% ≥VGPR rate in three cohorts, including those with lower doses and less frequent dosing schedules. ≥CR rates in C1–4 ranged from 62–92%, and responses deepened over time. |
| Higher belamaf starting doses were associated with deeper and faster MRD- rates, regardless of dosing interval. In C1, 100% of patients with a CR achieved MRD negativity. |
| Rates of belamaf-related Grade 3/4 AEs were lowest among cohorts with lower doses and longer dosing intervals. Belamaf-related Grade 3/4 AEs occurred in 33% of 105 safety-evaluable patients. The most frequent non-ocular Grade 3/4 AEs were thrombocytopenia (30%), neutropenia (26%), and COVID-19 pneumonia (14%). |
| These findings show that belamaf + VRd produced highly effective tumor responses across all dosing schedules in patients with TI NDMM, with higher doses of belamaf associated with higher rates of MRD negativity. |
Abbreviations: ≥CR, complete response or better; ≥VGPR, very good partial response or better; ADC, antibody–drug conjugate; AE, adverse event; belamaf, belantamab mafodotin; BCMA, B-cell maturation antigen; C, cohort; CR, complete response; MRD, measurable residual disease; NDMM, newly diagnosed multiple myeloma; ORR, overall response rate; QxW, every x weeks; RR, relapsed/refractory; TI, transplant ineligible; VRd, bortezomib, lenalidomide, and dexamethasone.
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