FX.co ★ GSK: DREAMM-8 Phase III Trial Shows Positive Results In Relapsed/refractory Multiple Myeloma

GSK plc (GSK, GSK.L) announced on Monday that the DREAMM-8 phase III trial demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma.

The positive outcomes were observed in the DREAMM-8 phase III head-to-head trial, which evaluated the efficacy of Blenrep (belantamab mafodotin) in combination with pomalidomide plus dexamethasone (PomDex) compared to the standard of care, comprising bortezomib plus PomDex, as a second-line and later treatment option for relapsed or refractory multiple myeloma.

In the trial, the Blenrep combination reduced the risk of disease progression or death by nearly 50% compared to the standard of care combination.

Additionally, a positive trend in overall survival (OS) was noted, though it was not statistically significant at the interim analysis. OS follow-up is ongoing, and further analyses are planned.

Multiple myeloma ranks as the third most common blood cancer worldwide, often deemed treatable but not curable.

Blenrep is an antibody-drug conjugate that combines a humanized B-cell maturation antigen monoclonal antibody with the cytotoxic agent auristatin F via a non-cleavable linker. This drug linker technology is licensed from Seagen Inc., and the monoclonal antibody is produced using POTELLIGENT Technology, which is licensed from BioWa Inc., a subsidiary of the Kyowa Kirin Group.

At a median follow-up of 21.8 months, the median PFS for the belantamab mafodotin combination was not yet reached, compared to 12.7 months for the bortezomib combination.

After one year, 71% of patients in the belantamab mafodotin combination group were alive and had not experienced disease progression, compared to 51% in the bortezomib group.

GSK also stated that the safety and tolerability profile of the belantamab mafodotin combination aligned with the known profiles of the individual agents.

Consistent with results from the DREAMM-7 phase III trial, the DREAMM-8 trial showed that the belantamab mafodotin combination led to clinically meaningful improvements across secondary efficacy endpoints.

The latest findings are being presented today at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. These late-breaking data were highlighted in the official ASCO press program and published simultaneously in the New England Journal of Medicine.

Hesham Abdullah, Senior Vice President and Global Head of Oncology, R&D at GSK, commented, "The robust results from the DREAMM-8 phase III head-to-head trial alongside consistent data from two phase III trials highlight the potential for Blenrep combinations to redefine treatment for multiple myeloma at or after the first relapse. This is particularly exciting given the substantial unmet need for new and effective combinations once patients relapse or stop responding to initial treatments. We are actively sharing data and discussing our pathway forward with regulators."

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