Maria-Victoria Mateos, MD, PhD, Hospital Universitario de Salamanca, Spain, shares the subgroup analyses from the phase 3 DREAMM-7 trial. These data demonstrated the efficacy of belantamab mafodotin plus bortezomib and dexamethasone as a potential new standard of care for patients with relapsed/refractory (R/R) multiple myeloma (MM) after at least 1 prior line of therapy, compared with daratumumab, bortezomib and dexamethasone treatment.

These results were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

Transcript:

Hello, my name is Maria-Victoria Mateos. I work as a hematologist and director of the myeloma unit at the [Hospital Universitario de Salamanca] in Spain. I am attending ASCO 2024, where I will have the opportunity to present the results of the DREAMM-7 clinical study.

DREAMM-7 is a phase 3 clinical trial conducted in relapsed refractory multiple myeloma after at least 1 prior line of therapy in which belantamab mafodotin in combination with bortezomib and dexamethasone have been compared with daratumumab in combination with bortezomib and dexamethasone.

The rationale of [the] combination of these studies is based on the fact that the vast majority of the newly diagnosed myeloma patients are [right now] receiving proteasome inhibitors immunomodulatory drugs and anti-CD38 monoclonal antibodies. This means that at first relapse and beyond, the majority of the patients are going to be triple-class exposed, and we need novel compounds, novel mechanisms of actions, for these patients.

[Belantamab mafodotin] [is] a (B-cell maturation antigen) BCMA antibody conjugated with monomethyl auristatin F. The clinical trial design, as I previously pointed out, compared the [belantamab mafodotin + bortezomib and dexamethasone (BVD) and daratumumab, bortezomib, and dexamethasone (DVD)]. Baseline characteristics of the patients were well-balanced, and to note, nearly 50% of the patients in both arms were previously exposed to lenalidomide and 32% of them were even refractory to lenalidomide. Approximately 27% of the patients presented high-risk cytogenetic abnormalities. The primary end point was progression-free survival, and the trial met its primary end point. After a medium follow-up of 28 months, [belantamab mafodotin + bortezomib and dexamethasone] (BELA-VD) resulted in a median progression for survival of 36.6 months versus 13.4 months for [daratumumab, bortezomib, and dexamethasone] (DARA-VD) with a hazard ratio of 0.4.

This means that the median [progression-free survival] (PFS) prolongation for BELA-VD in comparison with DARA-VD was 23 months. This superiority was maintained across the different group of patients including those with disease refractory to lenalidomide or patients with high-risk cytogenetic abnormalities. This superiority translated also into an early but strong trend to benefit in overall survival. [The] response rate [was] also superior for BELA-VD and the complete remission rate or better was the double for BELA-VD in comparison with DARA-VD. It's important to note that the minimal residual disease negativity rate was also superior for BELA-VD.

In terms of safety profile, numerically, BELA-VD resulted in a higher incidence of adverse events, hematological and non-hematological, but when this incident was adjusted to the time of exposition, the difference was not so evident. However, ocular toxicity keratopathy was the most frequent adverse event in relation with the administration of belantamab mafodotin. The most frequent one was blurred vision, reported in up to 77% of the patients, grade 3 to 4 in 34 [patients].

In order to evaluate the keratopathy, the best corrected visual equity was evaluated in the patients. I would like to remark that if we consider all patients with a visual equity normal at the moment of the baseline situation, 34% of the patients experienced a worsening in the visual equity to what we can call blurred vision, and only 2% of the patients [had] what we can call impaired vision.

Those modifications and those delays, the vast majority of the patients resolved. Quality of life has been evaluated and it's important to note that it was similar in both arms. All these data clearly support the use of BELA-VD as a new potential standard of care for relapsed/refractory multiple myeloma after at least 1 prior line of therapy, based on the data I've just presented. The efficacy data are robust, the safety profile is acceptable, and the administration of belantamab [mafodotin] is quite easy. Thank you very much.

Source:

Mateos MV, Robak P, Hus M, et al. DREAMM-7 update: Subgroup analyses from a phase 3 trial of belantamab mafodotin (belamaf) + bortezomib and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in relapsed/refractory multiple myeloma (RRMM). Presented at the ASCO Annual Meeting. May 31–June 4, 2024; Chicago, IL. Abstract 7503