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GEM-BELA-VRd: Belantamab mafodotin in combination with VRd for transplant-eligible NDMM

By Jennifer Reilly

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Oct 24, 2024

Learning objective: After reading this article, learners will be able to cite a new clinical development in newly diagnosed multiple myeloma.



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.This focused on ocular toxicities, as well as durability of response and MRD negativity rates over the different phases of treatment.1


Key learnings:

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.

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.

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.

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.

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.

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.

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.

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.

References

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