Blenrep Enhances Survival in DREAMM-7 Phase III Trial for Relapsed Multiple Myeloma

LONDON, UK I November 14, 2024 I GSK plc (LSE/NYSE: GSK) today revealed promising results from an interim analysis of the DREAMM-7 phase III clinical trial. The trial evaluated Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma. The combination therapy achieved the key secondary endpoint of overall survival (OS), demonstrating that belantamab mafodotin, when used with BorDex, significantly reduced the risk of death compared to the standard-of-care treatment with daratumumab plus BorDex.

Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D at GSK, highlighted the significance of these results. He stated that the overall survival data from the DREAMM-7 trial underscore the potential of the Blenrep combination to extend the lives of patients with relapsed or refractory multiple myeloma. He described the advancement as statistically significant, clinically meaningful, and potentially transformative for patient treatment. GSK anticipates sharing these findings with health authorities and presenting the complete results at the American Society of Hematology Annual Meeting next month.

The interim analysis, along with safety data, is set to be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition on December 9, 2024. The DREAMM (Driving Excellence in Approaches to Multiple Myeloma) clinical development program continues to explore the potential of belantamab mafodotin in earlier treatment lines and in combination with both novel and standard therapies. Besides DREAMM-7, the program includes the ongoing DREAMM-8 phase III trial, which evaluates belantamab mafodotin combined with pomalidomide and dexamethasone against bortezomib with pomalidomide and dexamethasone.

A phase III study targeting newly diagnosed, transplant-ineligible multiple myeloma patients is expected to commence by the end of 2024 as part of the DREAMM initiative. In the same year, combinations involving belantamab mafodotin have been filed in several regions, including the United States, European Union, Japan, United Kingdom, Canada, and Switzerland, for the treatment of relapsed or refractory multiple myeloma based on the outcomes of the DREAMM-7 and DREAMM-8 trials. Additionally, China's National Medical Products Administration has granted Breakthrough Therapy Designation and priority review for the regulatory application of belantamab mafodotin in combination with BorDex, leveraging the results of DREAMM-7.

The DREAMM-7 phase III clinical trial is a multicenter, open-label, randomized study designed to assess the efficacy and safety of belantamab mafodotin with BorDex versus daratumumab with BorDex in patients with relapsed or refractory multiple myeloma, who have undergone at least one prior treatment and shown disease progression. A total of 494 participants were randomized in a 1:1 ratio to receive either the belantamab mafodotin combination or the daratumumab combination. Belantamab mafodotin was administered at 2.5mg/kg intravenously every three weeks.

The primary endpoint of the trial is progression-free survival (PFS) as determined by an independent review committee. Key secondary endpoints include overall survival (OS), duration of response (DOR), and minimal residual disease (MRD) negativity rate assessed by next-generation sequencing. Other secondary endpoints encompass overall response rate (ORR), safety, and patient-reported quality of life outcomes.

Multiple myeloma, the third most common blood cancer worldwide, remains treatable but not curable, with over 180,000 new cases diagnosed annually. Research into new therapies is essential as the disease often becomes refractory to existing treatments.

Blenrep is an antibody-drug conjugate consisting of a humanized B-cell maturation antigen monoclonal antibody linked to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc., and the monoclonal antibody is produced using POTELLIGENT Technology from BioWa Inc., a member of the Kyowa Kirin Group. Blenrep is approved as monotherapy in Hong Kong, Israel, and Singapore.

GSK is committed to advancing oncology treatment, focusing on hematologic malignancies, gynecologic cancers, and other solid tumors through breakthroughs in immuno-oncology and tumor-cell targeting therapies. GSK is a global biopharma company dedicated to combining science, technology, and talent to stay ahead of disease.