The Food and Drug Administration (FDA) accepted a biologics license application (BLA) for Blenrep(belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for the treatment of patients with multiple myeloma who have previously received at least one line of therapy.
When a BLA is submitted, it means companies are requesting permission to introduce and distribute a drug for wider use, according to the FDA’s website.
“Relapsed/refractory multiple myeloma treatment could be transformed by additional, efficacious treatment options with manageable side effects and community-based administration,” Hesham Abdullah, senior vice president, global head oncology said in a news release from GSK, the manufacturer of Blenrep. “The evidence from DREAMM-7 and DREAMM-8 supporting our Blenrep combinations submission has been further strengthened by the statistically significant overall survival (OS) results from the DREAMM-7 trial. We look forward to working with the FDA on this review.”
Glossary
Progression-free survival: how long a person lives without their disease getting worse.
Overall survival (OS): the time from the start of treatment when a patient with cancer is still alive.
Primary end points: main goals measured at the end of a study to see if the treatment worked.
Minimal residual disease negativity rate: the percentage of patients who have no detectable cancer cells remaining after treatment.
Duration of response: the length of time a person's disease remains in remission after treatment.
The U.S. application is based on results from the Phase 3 DREAMM-7 and DREAMM-8 trials. Both trials showed statistically significant and clinically meaningful improvements in progression-free survival (PFS) for Blenrepcombinations compared to standard-of-care triplet combinations in relapsed or refractory multiple myeloma, meeting their primary end points.
In addition, both trials showed clinically meaningful improvements in secondary end points, including deeper and more durable responses, compared with standard-of-care regimens. The safety profile of Blenrepcombinations was generally consistent with the known profiles of the individual drugs.
The DREAMM-7 trial also met the key secondary end point of OS, showing a statistically significant and clinically meaningful benefit favoring the Blenrep combination. A positive trend in OS was observed in DREAMM-8 but was not statistically significant at the time of interim analysis. Follow-up for OS is still being measured. Efficacy and safety data from this analysis will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition on December 9.
A total of 494 participants were given treatment in the DREAMM-7 trial. This trial evaluated the efficacy and safety of Blenrep plus BVd compared with a combination of Darzalex (daratumumab) and bortezomib plus dexamethasone (DVd). The primary end point was PFS. Key secondary endpoints included overall survival, duration of response and the minimal residual disease negativity rate.
Regarding the DREAMM-8 trial, a total of 302 participants were giving treatment. This trial evaluated the efficacy and safety of Blenrep in combination with pomalidomide plus dexamethasone (BPd) compared to a combination of bortezomib and pomalidomide plus dexamethasone (PVd). The primary end point was PFS. Key secondary endpoints included overall survival and the minimal residual disease negativity rate.
Both trials were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Patients in the DREAMM-8 study were more heavily pre-treated compared with patients from the DREAMM-7 study, according to the news release.
According to the release, this year, six major regulatory filings for Blenrep combinations in the treatment of relapsed or refractory multiple myeloma have been accepted, driven by results from the DREAMM-7 and DREAMM-8 trials.
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