GSK presents intermediate results in relapsed or refractory patients at ASCO
In patients with relapsed or refractory multiple myeloma, treatment with belantamab mafodotin in combination with bortezomib and dexamethasone (BorDex) nearly tripled median progression-free survival compared with standard daratumumab therapy more BorDex. These are the results released today by the pharmaceutical company GSK, relating to an intermediate analysis of the Dreamm-7 phase 3 study which is presented today during the ‘plenary series’ of the American Society of Clinical Oncology (ASCO).
The analysis – we read in a note – highlights a statistically and clinically significant improvement with the combination belantamab mafodotin (243), with a 59% reduction in the risk of disease progression (Pfs) or death compared to the combination of daratumumab ( 251). With a median follow-up of 28.2 months, the median Pfs was 36.6 months with the belantamab mafodotin combination compared to 13.4 months with daratumumab treatment. The Pfs effect, the primary endpoint, was observed in all prespecified subgroups, including those refractory to lenalidomide and those with high-risk cytogenetics. The safety and tolerability profile of the belantamab mafodotin combination was consistent with the known profile of the individual agents. “The substantial progression-free survival benefit and strong overall survival trend compared to a standard-of-care combination with daratumumab – says Hesham Abdullah, senior vice president, Global Head Oncology, R&D, GSK – reinforces our belief in the potential of combination of belantamab mafodotin in redefining the treatment of multiple myeloma at or after first relapse. We plan to share these findings with health authorities around the world.”
The combination of belantamab mafodotin also led to clinically meaningful improvements in all secondary efficacy endpoints, including a doubling of the complete response rate, minimal residual disease (MRD) negativity rate, and median duration of response (Dor). At the interim analysis, a strong and clinically significant overall survival (OS) trend was observed, with a 43% reduction in the risk of death, which however did not yet reach the provisional criteria for statistical significance of OS. Follow-up continues and further analyzes are planned.
“These results from Dreamm-7 – adds María-Victoria Mateos, head of the Myeloma and Clinical Trials Unit, Department of Hematology and professor of Medicine at the University of Salamanca, Spain, and principal investigator of the study – show how belantamab mafodotin in combination with BorDex represents a significant improvement over the daratumumab-based regimen in the second-line treatment of multiple myeloma. Anti-Bcma (Anti-B-cell maturation antigen) therapies are helping to improve outcomes for multiple myeloma patients and the availability of a standard option, such as belantamab mafodotin, which can be administered in a The oncology treatment in which most patients are treated – he concludes – has the potential to transform the way we treat myeloma during or after the first relapse”.
Multiple myeloma is a blood cancer, the third most common globally. Every year, around the world, there are an estimated 176 thousand new cases. The pathology often becomes resistant to available therapies, which is why the search for new treatments is important.