Belantamab Mafodotin Plus PomDex Boosts PFS in R/R Multiple Myeloma

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The phase 3 DREAMM-8 trial (NCT04484623) of belantamab mafodotin (Blenrep) given in combination with pomalidomide and dexamethasone (PomDex) for the treatment of relapsed/refractory (R/R) multiple myeloma met its primary end point of progression-free survival (PFS), according to findings observed at a prespecified interim analysis.¹

In the DREAMM-8 study, investigators are evaluating belantamab mafodotin plus PomDex vs the standard of care treatment consisting of bortezomib plus PomDex as a second-line and later option for the treatment of patients with R/R multiple myeloma. The PFS result was unblinded early based on the recommendation by an independent data monitoring committee.

Further positive headline results from this analysis showed that the combination of belantamab mafodotin and PomDex showed significantly extended time to disease progression or death compared with bortezomib plus PomDex, and for overall survival (OS), there was a trend favoring the experimental combination. OS continues to be followed.

“The results seen in both DREAMM-7 [NCT04246047] and DREAMM-8 provide strong clinical evidence of the robust efficacy shown with belantamab mafodotin in use with standard of care combinations. We now look forward to discussing these data with regulators,” said Hesham Abdullah, senior vice president, global head oncology, research and development, GSK, in a press release. “If approved, we believe these combinations have the potential to redefine the treatment of relapsed or refractory multiple myeloma and advance the standard of care.”

In addition to the positive efficacy findings, the regimen including belantamab mafodotin demonstrated promising safety and tolerability. This study showed data that were broadly consistent with the known safety profile of each agent individually.

“This is exciting news for patients given the high unmet medical need for both efficacious and easily administered therapies with differing mechanisms of action,” added Abdullah in the press release.

The combination of belantamab mafodotin (Blenrep) with bortezomib (Velcade) and dexamethasone (BorDex) is also being evaluated in the phase 3 DREAMM-7 trial.² Findings from this study were recently presented at the American Society of Clinical Oncology (ASCO) Plenary Series: February Session.

Looking at the interim analysis from the phase 3 study, the combination demonstrated a statistically significant and clinically meaningful improvement in PFS vs daratumumab plus BorDex in the second-line and later treatment of patients with R/R multiple myeloma, meeting the primary end point of the study.

According to Maria-Victoria Mateos, MD, PhD, head of myeloma and clinical trials unit, hematology department and professor of medicine at the University of Salamanca, Spain, and DREAMM-7 principal investigator, these findings support the belantamab mafodotin combination as a potential new standard-of-care option for this patient population.

“Belantamab mafodotin in combination with BorDex could offer the potential for a BCMA-targeted treatment option with wide patient eligibility and an in-office infusion process in a community oncology treatment center, potentially improving the patient experience,” Mateos told Targeted Oncology^TM in an interview.

Behind the DREAMM-8 Study in Multiple Myeloma

DREAMM-8, a multicenter, open-label, randomized trial, is evaluating the efficacy and safety of belantamab mafodotin plus PomDex and enrolled a total of 302 patients.

In this second phase 3 trial evaluating the belantamab mafodotin combination in a head-to-head fashion to a standard of care in the second-line or later setting, patients with R/R multiple myeloma who have previously been treated with at least 1 prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, are eligible for enrollment.³

Patients must have been aged 18 years or older, have documented disease progression during or after their most recent therapy, have a confirmed diagnosis of multiple myeloma as defined by the international myeloma working group criteria, have an ECOG performance status of 0 to 2, have at least 1 aspect of measurable disease, have undergone autologous stem cell transplant or are considered transplant ineligible, have adequate organ system functions, and have all prior treatment-related toxicities resolved to ≤ grade 1 at the time of enrollment, except for alopecia, to be eligible for the study.

The primary end point of the study is PFS, and secondary end points include OS, overall response rate, duration of response, minimal residual disease negativity as assessed by next-generation sequencing, safety, and patient-reported and quality of life outcomes.

REFERENCES:

1. GSK announces positive results from DREAMM-8 phase III trial for Blenrep versus standard of care combination in relapsed/refractory multiple myeloma. News release. GSK plc. March 7, 2024. Accessed March 7, 2024. https://tinyurl.com/5n6mz3jv

2. Mateos MV, Robak P, Hus M, et al. Results from the randomized phase III DREAMM-7 study of belantamab mafodotin (belamaf) + bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in relapsed/refractory multiple myeloma (RRMM). Presented at: 2024 February ASCO Plenary Series. Abstract 439572.

3. Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma (DREAMM 8). ClinicalTrials.gov. Accessed March 7, 2024. https://clinicaltrials.gov/study/NCT04484623