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GEM-BELA-VRd: Belantamab mafodotin in combination with VRd for transplant-eligible NDMM
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At the 21st IMS Annual Meeting 2024, González-Calle presented results from the GEM-BELA-VRd (NCT04802356) trial, which investigated the safety and efficacy of the addition of belantamab mafodotin to the standard-of-care regimen of VRd for the treatment of patients with transplant-eligible NDMM.1 This focused on ocular toxicities, as well as durability of response and MRD negativity rates over the different phases of treatment.1 |
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During the induction phase, the most common AEs were ocular, with 40% of patients experiencing blurred vision, with a BCVA of 20/50. However, blurred vision resolved in 94% of patients following adjunctive therapy or dose adjustments. Treatment discontinuation due to ocular AEs occurred in 2% of patients. |
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In the consolidation phase, a BCVA of 20/50 was observed in 19% of patients, with 88% of cases resolving after adjunctive therapy or dose adjustments. There were no discontinuations due to ocular toxicity during this phase. |
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At 1 year of maintenance, a BCVA of 20/50 was observed in 26% of patients, with 91% of cases resolving through adjunctive therapy or dose adjustments. During this phase, 4% of patients discontinued treatment due to ocular toxicity. |
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The ORR remained consistent across all treatment phases at 94%, with the proportion of CR increasing from 36% during induction to 82% at 1 year of maintenance. |
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The proportion of patients with MRD negativity also increased throughout the treatment phases, from 60.9% at induction to 91.2% after 1 year of maintenance. |
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At 24 months, the PFS and OS rates were both 85% in the total cohort treated with Bela-VRd. These rates were similar in patients with high-risk cytogenetics. |
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The safety profile of the Bela-VRd combination was largely comparable to that of the VRd regimen, with the exception of an increase in ocular toxicities. In most cases, ocular toxicities were resolved through dose adjustments. |
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Efficacy data are also promising, with durable responses and increasing MRD negativity observed throughout the different phases of treatment, indicating further investigation of belantamab mafodotin in the newly diagnosed setting. |
Abbreviations: AE, adverse event; BCVA, best corrected visual acuity; Bela-VRd, belantamab mafodotin-bortezomib-lenalidomide-dexamethasone; CR, complete response; IMS, International Myeloma Society; MRD, measurable residual disease; NDMM, newly diagnosed multiple myeloma; OS, overall survival; PFS, progression-free survival; VRd, bortezomib-lenalidomide-dexamethasone.
- González-Calle V. Belantamab mafodotin in combination with VRd for the treatment of newly diagnosed transplant eligible multiple myeloma patients: Results from the phase II, open label, multicenter, GEM-BELA-VRd trial. Oral abstract #64. Presented at: 21st International Myeloma Society Annual Meeting; Sep 25–28, 2024; Rio de Janeiro, BR.
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