Characterization of Ophthalmic Examination Findings (OEF) and Impact on Reading and Driving in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Belantamab Mafodotin (Belamaf)

Introduction/Background/Significance: In the phase 3, randomized DREAMM-7 and DREAMM-8 trials, belamaf plus standard backbone therapies demonstrated significant progression-free survival benefit in patients with RRMM after ≥1 line of therapy, and significant overall survival benefit in DREAMM-7. Ocular events were common in patients treated with belamaf-based regimens but were reversible and effectively managed with dose modifications. Efficacy was maintained in these patients despite extended dose delays. The aim of this analysis is to provide a post hoc characterization of OEFs during treatment in patients from DREAMM-7 (data cutoff, October 2, 2023) and DREAMM-8 (data cutoff, January 29, 2024).

Materials and Methods/Case Presentation/Objective: DREAMM-7 (NCT04246047) compared belamaf, bortezomib, and dexamethasone (BVd) with daratumumab and Vd; DREAMM-8 (NCT04484623) compared belamaf, pomalidomide, and dexamethasone (BPd) with PVd. An OEF grade was determined based on severity of corneal exam findings and changes in best corrected visual acuity (BCVA). A grade of ≥2 drove protocol-recommended belamaf dose modifications, which included dose delays until resolution and dose reductions. However, a patient with a grade ≥2 OEF may have experienced only corneal exam findings or a mild BCVA change to < 20/50 without a meaningful vision change. Occurrences (≤5) and time to onset of grade ≥2 OEFs were assessed, and the impact of extended belamaf dose delays ( >9 weeks) on responses to treatment was evaluated.

Results/Description/Main Outcome Measure(s)

Of the 211 patients treated with BVd in DREAMM-7 who had normal BCVA at baseline, almost two-thirds did not experience a BCVA change of ≥20/50, despite most patients having ≥1 grade ≥2 OEF. Among those with a BCVA change to ≥20/50 on treatment, this change was experienced for ≈11% of their time on treatment. Patients with normal baseline BCVA were stratified into 2 groups according to bilateral BCVA change; no change to ≥20/50 and change from ≥20/50 to < 20/200. Recurrences of OEFs with or without meaningful changes in BCVA were common. For patients with multiple occurrences, the duration of each occurrence was consistent and predictable across groups, ranging from 12-13 weeks (< 20/50) and 12-16 weeks (≥20/50-< 20/200). Overall, ≥20/200 BCVA changes were rare (2%) and resolved in all patients with adequate follow-up. Similar results were observed with BPd in the DREAMM-8 trial. In patients with extended ( >9 week) belamaf dose delays in DREAMM-7 (n=127) and DREAMM-8 (n=82), 92% and 94%, respectively, maintained or deepened their response to treatment during their first extended dose delay.

Conclusions: Of patients with normal visual acuity at baseline who were receiving belamaf-containing regimens, almost two-thirds did not experience a clinically meaningful BCVA change of ≥20/50. Of the patients who did, this was experienced for ≈11% of time on treatment. Ocular monitoring frequency can be guided by the resolution data. The majority of patients maintained or deepened their responses during their first extended dose delay.

This abstract was accepted and previously presented at the European Hematology Association 2025 Congress. All rights reserved.

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Drug-linker technology licensed from Seagen Inc; monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa.