GSK has announced positive results from an interim analysis of the phase III DREAMM-8 comparative trial evaluating belantamab mafodotin in combination with pomalidomide plus dexamethasone (PomDex), against a standard of care, bortezomib plus PomDex, as second-line and subsequent treatment for patients with relapsed or refractory multiple myeloma. These late-breaking data were presented during the annual meeting of the American Society of Clinical Oncology (ASCO).
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D at GSK, said: “With the strong results from the DREAMM-8 phase III head-to-head trial, we now have consistent data from two phase III trials supporting the potential of the belantamab mafodotin combinations to redefine the treatment of multiple myeloma from the first relapse. This is exciting news given the large unmet medical need for new, effective combinations once patients relapse or stop responding to initial treatments. We continue to share data and discuss our path forward with regulatory agencies”.
According to the study data, a statistically and clinically significant improvement (hazard ratio) was observed in the primary endpoint of progression-free survival (PFS). [HR]: 0.52 [intervalo de confianza (IC) del 95 %: 0,37-0,73]p value A benefit of belantamab mafodotin plus PomDex was observed in all prespecified subgroups, including those with poor prognostic characteristics, such as lenalidomide-refractory patients and patients with high-risk cytogenetics.
A positive overall survival (OS) trend was observed, but not statistically significant (HR: 0.77 [IC del 95 %: 0,53-1,14]) in this interim analysis. OS monitoring continues and further analysis is planned. At the end of one year, 83% (95% CI: 76-88) of patients were alive in the belantamab mafodotin combination group versus 76% (95% CI: 68-82) in the belantamab mafodotin combination group. bortezomib combination. The safety and tolerability profile of the belantamab mafodotin combination was broadly consistent with the known safety profiles of these individual drugs.
Suzanne Trudel, MD, Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada, commented: “The profound progression-free survival benefit seen in DREAMM-8 highlights the potential of belantamab mafodotin. , when used with pomalidomide and dexamethasone, to improve outcomes for patients with relapsed/refractory multiple myeloma. ANDThis combination may have the potential to redefine multiple myeloma treatment from first relapse, a setting in which patients may benefit from novel therapies.”.
Similar to the results observed in the phase III DREAMM-7 head-to-head trial, in DREAMM-8 the belantamab mafodotin combination also consistently produced clinically meaningful improvements in all secondary efficacy endpoints, demonstrating that the belantamab mafodotin combination resulted in deeper improvements and more durable responses compared to the bortezomib combination. Key improvements included complete response rate (CR) or better (more than two-fold improvement); negative minimal residual disease (MRD) rate (nearly five-fold improvement); and duration of response (median not yet reached with the belantamab mafodotin combination versus 17.5 months with the bortezomib combination).
Global health status quality of life, as measured by the EORTC-QLQ-C30, remained stable in both treatment arms over time, suggesting that treatment did not lead to any decrease in related quality of life. with general health.
