Belantamab-Mafodotin (4) – Blenrep®

• Clinical trials
  • The DREAMM-8 trial is an ongoing, open-label, multicentre Phase IIItrial comparing belantamab-mafodotin in combination with pomalidomide and dexamethasone (BPd) against pomalidomide in combination with bortezomib and dexamethasone (PVd).

a) Adults with relapsed or refractory multiple myeloma who have received one to three prior lines of treatment; prior treatment includes lenalidomide

• An additional benefit is not proven.
• For the benefit assessment of belantamab-mafordotin in combination with pomalidomide and dexamethasone, the pharmaceutical manufacturer has submitted the results of the pivotal DREAMM-8 study as supplementary evidence, but does not use these to demonstrate an additional benefit.
• In the DREAMM-8 study, the combination therapy PVd was used exclusively in the comparator arm. For the majority of the patients included, PVd does not constitute the appropriate comparator therapy, as PVd was designated as a suitable comparator therapy within the context of individualised treatment only for patients who are refractory to an anti-CD38 antibody and lenalidomide.
• For the patient groups (1 to 3 or ≥ 4 prior treatments), only subgroup results are available for the refractory patient population. However, details regarding patient characteristics and the type and duration of prior treatments are lacking.
• Consequently, on the basis of the available information, it is not possible to adequately assess the extent to which PVd constitutes a suitable individualised therapy for the refractory patient population.
• The data presented from the DREAMM-8 study therefore do not allow for a comparison with the appropriate comparator therapy. Accordingly, the pharmaceutical manufacturer does not use the results of the DREAMM-8 study to derive any additional benefit.

b) Adults with relapsed or refractory multiple myeloma who have received at least four prior treatments; prior treatment includes lenalidomide

• The additional benefit is not proven.
• For the benefit assessment of belantamab-mafodotin in combination with pomalidomide and dexamethasone, the pharmaceutical manufacturer additionally submits the results of the pivotal DREAMM-8 trial, but does not use them to establish additional benefit.
• In the DREAMM-8 study, only the combination therapy PVd was used in the comparator arm. For the majority of patients included in the study, PVd does not constitute the appropriate comparator therapy, as PVd was designated as a suitable comparator therapy within the context of individualised treatment only for patients who are refractory to an anti-CD38 antibody and lenalidomide.
• For the patient groups (1 to 3 or ≥ 4 prior treatments), only subgroup results are available for the refractory patient population. However, details regarding patient characteristics and the type and duration of prior treatments are lacking.
• Consequently, on the basis of the available information, it is not possible to adequately assess the extent to which PVd constitutes a suitable individualised therapy for the refractory patient population.
• The data presented from the DREAMM-8 study therefore do not allow for a comparison with the appropriate comparator therapy. Accordingly, the pharmaceutical manufacturer does not use the results of the DREAMM-8 study to derive any additional benefit.

Courtesy translation only, please refer to the German original.