By late 2024, GSK plans to initiate a Phase III study for newly diagnosed multiple myeloma patients who are not eligible for a transplant. Credit: GSK.

GSK has announced positive headline interim analysis outcomes from a Phase III trial, which is evaluating Blenrep (belantamab mafodotin) along with bortezomib and dexamethasone (BorDex) for relapsed or refractory multiple myeloma (r/r MM) as a later or second-line treatment.

The head-to-head, randomised, multi-centre, open-label, DREAMM-7 trial assesses the efficacy and safety of Blenrep in conjunction with BorDex.

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It enrolled 494 subjects who were randomised to receive either the Blenrep combination or daratumumab with BorDex.

The primary endpoint is progression-free survival (PFS), with key secondary endpoints, including overall survival (OS), duration of response (DOR), and minimal residual disease (MRD) negativity rate.

This trial met its key secondary endpoint of OS, indicating a significant reduction in the risk of death when compared to the standard of care.

The Driving Excellence in Approaches to Multiple Myeloma (DREAMM) programme is actively exploring the potential of Blenrep in various treatment combinations and stages of MM, including the ongoing DREAMM-8 Phase III trial, comparing the therapy with pomalidomide and dexamethasone against bortezomib with the similar therapies.

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By late 2024, the company plans to initiate a Phase III study for newly diagnosed multiple myeloma patients who are not eligible for a transplant.

GSK Oncology, R&D global head and senior vice-president Hesham Abdullah said: “The overall survival results from the DREAMM-7 trial underscore the potential for this Blenrep combination to extend the lives of patients with r/r MM.

“This is a statistically significant and clinically meaningful advancement for patients and potentially transformative for treatment.”

Regulatory filings for Blenrep combinations have been submitted in several regions, including the EU, Japan, UK, Canada, Switzerland, and the US, based on the outcomes of the DREAMM-7 and DREAMM-8 trials.

It has received breakthrough status and priority review for its combination with BorDex from China’s National Medical Products Administration (NMPA).

An antibody-drug conjugate, Blenrep combines a B-cell maturation antigen monoclonal antibody with the cytotoxic agent auristatin F. It received approval as a monotherapy in Israel, Singapore, and Hong Kong.

In November 2023, the company reported positive headline outcomes from the Phase III DREAMM-7 head-to-head clinical trial of Blenrep for MM.