August 26, 2020: “GlaxoSmithKline announced the European Commission has granted conditional marketing authorisation for BLENREP (belantamab mafodotin) as monotherapy for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
BLENREP is a first-in-class humanised anti-BCMA (B-cell maturation antigen) treatment for these patients whose disease has progressed despite the current standard of care.
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “The approval of BLENREP marks an important step forward for patients in Europe where nearly 50,000 new cases of multiple myeloma are diagnosed each year.
Unfortunately, most of these patients will relapse or stop responding to current therapies so I am pleased that today’s news will give patients with limited treatment options access to the first approved anti-BCMA therapy.”
The approval is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study, including 13-month follow-up data.
These data demonstrated that treatment with single-agent BLENREP, administered as a 2.5 mg/kg dose every three weeks (Q3W), resulted in an overall response rate of 32%. The median duration of response was 11 months and median overall survival was 13.7 months.
The safety and tolerability profile were consistent with previously reported data on BLENREP.
The most commonly reported adverse events in the 2.5 mg/kg arm (greater than or equal to 20%) were keratopathy/microcyst-like epithelial changes or MECs (71%), thrombocytopenia (38%), anaemia (27%), blurred vision events (25%), nausea (25%), pyrexia (23%), increased aspartate aminotransferase (AST) (21%), infusion-related reactions (21%), and lymphopenia (20%).
Dr Katja Weisel, Deputy Director and Associate Professor of Haematology/Oncology in the Department of Oncology, Haematology and Bone Marrow Transplantation with Department of Pneumonology, University Medical Centre Hamburg-Eppendorf in Germany and an investigator for the DREAMM-2 trial, said: “Despite advances in treatment, multiple myeloma remains incurable and patients continue to cycle through therapies, with their prognosis worsening with each relapse.
The approval of BLENREP, with its novel mechanism of action, represents a new class of treatment that patients can turn to when their cancer stops responding to other standard of care options.”
BLENREP employs a multi-faceted mechanism of action and is directed toward BCMA, a cell-surface protein that plays an important role in the survival of plasma cells and is expressed on multiple myeloma cells.
Dr Brian G.M. Durie, Chairman of the Board of the International Myeloma Foundation, said: “The EC approval of BLENREP is good news for patients with refractory multiple myeloma whose cancer continues to progress and are in dire need of new treatment options.
We appreciate GSK’s efforts to bring this new therapy to patients in the EU and for the commitment to addressing the needs of the multiple myeloma community.”
BLENREP was granted PRIME designation in 2017 and the Conditional Marketing Authorisation Application was reviewed under European Medicines Agency’s accelerated assessment procedure, which is given if the EMA’s Committee for Medicinal Products for Human Use determines the treatment is of major interest from a public health perspective and represents a therapeutic innovation.
Earlier this month, the US Food and Drug Administration approved BLENREP as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent, following a priority review for the company’s Biologics License Application.
DREAMM-2
DREAMM-2 is an open label study of BLENREP. Patients in the trial had actively progressing multiple myeloma that had worsened despite current standard of care and were randomised to two arms to receive either 2.5 mg/kg or 3.4 mg/kg BLENREP Q3W.
Overall, patients in DREAMM-2 had more advanced disease, poorer prognosis and performance status and also had a greater number of prior lines of therapy in comparison with patients in DREAMM-1, the first time in human study of BLENREP.”
https://www.gsk.com/en-gb/media/press-releases/european-commission-approves-blenrep-belantamab-mafodotin-for-the-treatment-of-patients-with-relapsed-and-refractory-multiple-myeloma/
