Blenrep Improves Survival in DREAMM-7 Trial for Relapsed Multiple Myeloma

LONDON, UK I November 14, 2024 I GSK plc (LSE/NYSE: GSK) today announced positive headline results from a planned interim analysis of the DREAMM-7 head-to-head phase III trial evaluating Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma. The trial successfully met the key secondary endpoint of overall survival (OS), demonstrating that belantamab mafodotin, when combined with BorDex, significantly reduced the risk of death compared to the standard of care daratumumab plus BorDex.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, commented on the results, stating, “The overall survival findings from the DREAMM-7 trial highlight the potential for this Blenrep combination to extend the lives of patients with relapsed/refractory multiple myeloma. This represents a statistically significant and clinically meaningful advancement for patients, and it could potentially transform treatment. We eagerly anticipate sharing these data with health authorities and presenting the full results at next month’s American Society of Hematology Annual Meeting.”

The interim analysis results, including safety data, will be presented at the upcoming 66th American Society of Hematology (ASH) Annual Meeting and Exposition on December 9, 2024, at 11:15 a.m. PT.

The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical development program continues to explore the potential of belantamab mafodotin in early lines of treatment and in combination with novel therapies and standard of care treatments. In addition to DREAMM-7, the program includes the ongoing head-to-head phase III DREAMM-8 trial, which is evaluating belantamab mafodotin in combination with pomalidomide and dexamethasone versus bortezomib in combination 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 program.

In 2024, belantamab mafodotin combinations have been submitted for approval in the US, European Union, Japan, United Kingdom, Canada, and Switzerland for the treatment of relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8 trials. In China, the National Medical Products Administration has granted Breakthrough Therapy Designation for belantamab mafodotin in combination with BorDex and has given priority review status for the regulatory application based on the results of DREAMM-7.

The DREAMM-7 phase III clinical trial is a multicenter, open-label, randomized trial assessing the efficacy and safety of belantamab mafodotin in combination with BorDex compared to a combination of daratumumab and BorDex in patients with relapsed/refractory multiple myeloma who have undergone at least one prior line of therapy, with documented disease progression during or after their most recent therapy.

A total of 494 participants were randomized on a 1:1 basis to receive either belantamab mafodotin in combination with BorDex or a combination of daratumumab and BorDex. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously every three weeks.

The primary endpoint of the study is progression-free survival (PFS) as evaluated by an independent review committee. The 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 include overall response rate (ORR), safety, and patient-reported and quality of life outcomes.

Results from DREAMM-7 were initially presented at the American Society of Clinical Oncology (ASCO) Plenary Series in February 2024, shared again at the 2024 ASCO Annual Meeting, and published in the New England Journal of Medicine.

Multiple myeloma, the third most common blood cancer globally, is generally treatable but not curable. There are over 180,000 new cases diagnosed worldwide each year. Research into new therapies is crucial as multiple myeloma often becomes refractory to available 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.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group. Blenrep is approved as monotherapy in Hong Kong, Israel, and Singapore.

GSK is a global biopharma company focused on maximizing patient survival through breakthroughs in immuno-oncology and tumor-cell targeting therapies, with a major emphasis on haematologic malignancies, gynecologic cancers, and other solid tumors.