GSK Plc (NYSE:GSK) has shared encouraging findings from the interim efficacy analysis of its DREAMM-7 phase III study, evaluating the anti-BCMA therapy, Blenrep (belantamab mafodotin), for relapsed/refractory multiple myeloma. The study successfully achieved its primary endpoint of progression-free survival (PFS).
According to the data, the combination of Blenrep with bortezomib plus dexamethasone (BorDex) demonstrated a statistically significant PFS benefit, surpassing the current standard of care regimen, daratumumab plus BorDex. This outcome marks a notable advancement in extending the time to disease progression or death for patients.
Additionally, the study revealed a strong and clinically meaningful overall survival (OS) trend. Further investigation will be conducted to follow up on OS, providing a comprehensive understanding of the therapy’s impact.
GSK intends to present the data from this interim efficacy analysis at an upcoming medical conference. Despite the challenges faced by the pharmaceutical industry, GSK’s shares have shown resilience, experiencing a 1.9% increase this year, in contrast to the industry’s decline of 22.7%.
It’s worth noting that Blenrep initially received accelerated approval as a monotherapy for relapsed or refractory multiple myeloma patients in 2020. This approval was based on the DREAMM-2 study’s overall response rate. However, the final approval hinged on confirmed clinical benefit from a randomized phase III study.
In November 2022, Blenrep faced a setback when sales were withdrawn from the U.S. market following the DREAMM-3 phase III confirmatory study’s failure to meet its primary endpoint of PFS, thereby not meeting FDA’s Accelerated Approval regulations.
Despite this setback, GSK remains committed to advancing research within the DREAMM clinical trial program. The ongoing DREAMM-8 phase III study is evaluating Blenrep in combination with pomalidomide and dexamethasone versus bortezomib in combination with pomalidomide and dexamethasone. Data from the DREAMM-8 study is anticipated in the second half of 2024.
While Blenrep retains approval in Europe, its sales have been significantly impacted by its withdrawal from the U.S. markets. Sales plummeted by 67% at a constant exchange rate in the first nine months of 2023. GSK continues to navigate the complexities of the market, focusing on the potential of Blenrep in combination therapies and the forthcoming data from ongoing studies.
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