FDA Accepts GSK’s Biologics License Application of Blenrep for Relapsed or Refractory Multiple Myeloma

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The FDA has accepted GSK’s Biologics License Application (BLA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BVd) and in combination with pomalidomide plus dexamethasone (BPd) for the treatment of relapsed or refractory multiple myeloma [RRMM] in patients previously treated with at least one therapy. According to the company, the BLA was supported by positive results from the Phase III DREAMM-7 and DREAMM-8 trials, and marks the sixth major regulatory filing acceptance this year for a Blenrep combination based on results of these trials.¹

“[RRMM] treatment could be transformed by additional, efficacious treatment options with manageable side effects and community-based administration. The evidence from DREAMM-7 and DREAMM-8 supporting our Blenrep combinations submission has been further strengthened by the statistically significant overall survival results from the DREAMM-7 trial. We look forward to working with the FDA on this review,” said Hesham Abdullah, SVP, global head oncology, GSK, in a press release.

The multicenter, open-label, randomized DREAMM-7 clinical trial is evaluating the efficacy and safety of Blenrep in combination with BVd compared to a combination of daratumumab and bortezomib plus dexamethasone (DVd) in patients with RRMM who received prior treatment with at least one line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. As part of the trial, 494 participants were randomly assigned in a 1:1 ratio to receive either BVd or DVd. The primary endpoint of the study was progression-free survival (PFS) as per an independent review committee, with key secondary endpoints including overall survival (OS), duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing.

The multicenter, open-label, randomized DREAMM-8 trial is evaluating the efficacy and safety of Blenrep in combination with BPd compared to a combination of bortezomib and pomalidomide plus dexamethasone (PVd). Patients in this study were more heavily pre-treated in that all had prior exposure to lenalidomide compared to patients enrolled in DREAMM-7. A total of 302 patients were randomly assigned in a 1:1 ratio to receive either BPd or PVd. The primary endpoint of the study is PFS as per an independent review committee, with secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing.

Results from both trials found that the Blenrep combinations demonstrated clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses compared to the respective standard of care combinations.¹ In DREAMM-7, Blenrep demonstrated a 59% reduction in the risk of disease progression or death compared to the daratumumab combination. The median PFS was 36.6 months with a median follow up of 28.2 months.

Grade 3 or higher non-ocular adverse events included thrombocytopenia, neutropenia, pneumonia, and anemia.²

The FDA has set a Prescription Drug User Fee Act action date for the BLA of July 23, 2025.¹

According to the National Cancer Institute, the current five-year survival rate for patients with multiple myeloma is 61.1%. Additionally, it is estimated that 12,540 people in the United States will die by the end of the year as a result of multiple myeloma, which accounts for 2% of all cancer deaths in the United States. Based on data from 2018 to 2021, an estimated 0.8% of men and women will be diagnosed with multiple myeloma at some point during their lifetime. On average, the rate of multiple myeloma has been decreasing by 1.8% on an annual basis.³

References

1. Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma. GSK. November 25, 2024. Accessed December 2, 2024. https://www.gsk.com/en-gb/media/press-releases/blenrep-combinations-accepted-for-review-by-the-us-fda-for-the-treatment-of-relapsedrefractory-multiple-myeloma/

2. DREAMM-7 phase III trial shows Blenrep combination nearly tripled median progression-free survival versus standard of care combination in patients with relapsed/refractory multiple myeloma. GSK. February 5, 2024. Accessed December 2, 2024. https://www.gsk.com/en-gb/media/press-releases/dreamm-7-phase-iii-trial-shows-pfs-improvement-and-strong-os-trend-for-blenrep-combo-versus-soc-combo-in-multiple-myeloma/

3. Cancer Stat Facts: Myeloma. NIH. Accessed December 2, 2024. https://seer.cancer.gov/statfacts/html/mulmy.html