Source: Sharecast
The FTSE 100 drugmaker said the trial, involving 494 participants, demonstrated that Blenrep combined with bortezomib and ‘dexamethasone’, or BorDex, achieved a statistically significant reduction in mortality risk compared to a standard treatment regimen of daratumumab plus BorDex.
It said the survival advantage, a key secondary endpoint of the trial, added to the growing evidence supporting Blenrep's clinical efficacy.
Detailed data from the interim analysis, including safety findings, was set to be presented at the American Society of Hematology Annual Meeting on 9 December.
The results would be submitted to health authorities globally to support regulatory filings in the US, EU, UK, Japan, Canada, and Switzerland, with China already granting breakthrough therapy designation and priority review for Blenrep in combination with BorDex based on the DREAMM-7 findings.
GSK said the DREAMM - ‘DRiving Excellence in Approaches to Multiple Myeloma - programme, which included other phase three trials such as DREAMM-8, continued to explore Blenrep’s potential in various therapeutic combinations and earlier stages of treatment.
Plans were also underway for a new phase three study in newly diagnosed, transplant-ineligible multiple myeloma patients by year-end.
Multiple myeloma, one of the most prevalent blood cancers worldwide, often develops resistance to existing therapies, underscoring the need for innovative treatments like Blenrep.
GSK’s Blenrep, an antibody-drug conjugate targeting B-cell maturation antigen, is currently approved as a monotherapy in several markets, including Hong Kong and Israel.
“The overall survival results from the DREAMM-7 trial underscore the potential for this Blenrep combination to extend the lives of patients with relapsed/refractory multiple myeloma,” said Hesham Abdullah, GSK’s senior vice-president and global head of oncology research and development.
“This is a statistically significant and clinically meaningful advancement for patients and potentially transformative for treatment.
“We look forward to sharing these data with health authorities and presenting the full results at next month's American Society of Hematology Annual Meeting.”
At 0819 GMT, shares in GSK were down 0.84% at 1,350.5p.
Reporting by Josh White for Sharecast.com.