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

(RTTNews) - GSK plc (GSK, GSK.L) announced Monday that DREAMM-8 phase III trial showed statistically significant and clinically meaningful improvement in primary endpoint of progression-free survival or PFS in relapsed/refractory multiple myeloma.

The positive results were reported in DREAMM-8 phase III head-to-head trial evaluating Blenrep (belantamab mafodotin), in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex, as a second line and later treatment for relapsed or refractory multiple myeloma.

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

Meanwhile, a positive overall survival or OS trend was observed but not statistically significant at the interim analysis. OS follow-up continues and further analyses are planned.

Multiple myeloma is the third most common blood cancer globally, which is generally considered treatable but not curable.

Blenrep is an antibody-drug conjugate comprising a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc., while the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

In the trial, at a median follow-up of 21.8 months, the median PFS was not yet reached with the belantamab mafodotin combination compared to 12.7 months in the bortezomib combination.

At the end of one year, 71% of patients in the belantamab mafodotin combination group compared to 51% in the bortezomib combination group were alive and had not progressed.

GSK further said the safety and tolerability profile of the belantamab mafodotin combination was broadly consistent with the known profile of the individual agents.

Similar to the results seen in the DREAMM-7 phase III head-to-head trial, in DREAMM-8 the belantamab mafodotin combination also resulted in clinically meaningful improvements consistently across secondary efficacy endpoints.

The company is presenting the latest data today at the 2024 American Society of Clinical Oncology or ASCO Annual Meeting in Chicago, IL.

These late-breaking data were featured in the official ASCO press programme and simultaneously published in the New England Journal of Medicine.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said, "With the robust results from the DREAMM-8 phase III head-to-head trial, we now have consistent data from two phase III trials supporting the potential for Blenrep combinations to redefine the treatment of multiple myeloma at or after first relapse. This is exciting news given the high unmet need for new and efficacious combinations once patients relapse or stop responding to initial treatments. We continue to share data and discuss our path forward with regulators."

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