UK-based pharmaceutical company GSK plc (NYSE: GSK) has reported positive results from a Phase III trial for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma (RRMM). The DREAMM-7 head-to-head study demonstrated that GSK’s BCMA-targeted antibody drug conjugate (ADC) achieved the key secondary endpoint of overall survival (OS), significantly reducing the risk of death when combined with BorDex versus the standard of care daratumumab plus BorDex.
Study Highlights and Efficacy
In the DREAMM-7 study, the combination of Blenrep with BorDex showed a significant improvement in overall survival compared to the standard therapy, positioning it as a potential new option for patients with RRMM. This achievement is particularly noteworthy given the challenges faced by patients with relapsed or refractory forms of multiple myeloma, where new treatment options are crucial.
Regulatory History and Global Filings
Blenrep was conditionally approved in the US in 2020 for the treatment of RRMM but was withdrawn from the market in 2022 following its failure to demonstrate efficacy in the confirmatory Phase III DREAMM-3 study. Despite this setback, the positive results from the DREAMM-7 and DREAMM-8 trials have led to filings for belantamab mafodotin combinations in the US, European Union, Japan, United Kingdom, Canada, and Switzerland in 2023 for the treatment of RRMM. In China, the drug has been awarded Breakthrough Therapy Designation (BTD) and priority review status for the same indication, reflecting its potential impact on the treatment landscape for multiple myeloma globally.-Fineline Info & Tech
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