GSK is carving out a niche for Blenrep in the second-line multiple myeloma setting, for which it projects multi-blockbuster potential for the antibody-drug conjugate.
GSK on Thursday revealed additional data from the Phase III head-to-head DREAMM-7 study, touting significantly better survival outcomes in multiple myeloma patients treated with its antibody-drug conjugate Blenrep (belantamab mafodotin) than with Johnson & Johnson’s Darzalex (daratumumab).
DREAMM-7 is one of two studies—alongside DREAMM-8—that GSK is using to plot the comeback of Blenrep after pulling the drug from the market in November 2022 when it failed a confirmatory trial. In June 2024, the pharma unveiled progression-free survival data from DREAMM-7, touting a 60% greater reduction in the risk of death or disease progression with Blenrep versus Darzalex.
In an oncology-focused virtual investor event at the time, GSK management touted the “multi-blockbuster” potential of Blenrep, which it is positioning as a second-line treatment for multiple myeloma. CCO Luke Miels during the call estimated that Blenrep could hit peak sales of over $3 billion and potentially dethrone Darzalex as the standard of care in this indication.
Follow-up data from the head-to-head study on Thursday were sparse, with GSK revealing only that patients treated with a Blenrep-based regimen saw a “statistically significant and clinically meaningful reduction in the risk of death,” versus a Darzalex-based combo. The pharma will present data from DREAMM-7 at the upcoming 2024 American Society of Hematology Annual Meeting in December 2024.
GSK is also “sharing these data with health authorities,” Hesham Abdullah, senior vice president and global head of Oncology R&D, said in a statement. In July 2024, the European Medicines Agency accepted GSK’s marketing authorization application for Blenrep, combined with either bortezomib and dexamethasone or pomalidomide and dexamethasone, for relapsed or refractory multiple myeloma.
Blenrep targets the BCMA protein, which is expressed on multiple myeloma cells. The drug carries a microtubule inhibitor payload that, when released inside cancer cells, triggers their cell cycle arrest and death.
The FDA originally approved Blenrep under its accelerated pathway in August 2020, allowing its use as a monotherapy for patients with multiple myeloma who had progressed after previous treatments with an immunomodulatory agent, an anti-CD38 antibody and a proteasome inhibitor.
To keep Blenrep on the market, GSK ran the Phase III confirmatory DREAMM-3 study. In November 2022, however, the pharma announced that DREAMM-3 fell short of its primary efficacy endpoint, unable to significantly improve progression-free survival versus pomalidomide plus dexamethasone. GSK withdrew the drug a few days later.
