EMA Accepts GSK Application for Blenrep Combinations in Multiple Myeloma Treatment

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The European Medicines Agency (EMA) has accepted GSK’s marketing authorization application (MAA) seeking approval of Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) for treating relapsed or refractory multiple myeloma (RRMM). EMA’s Committee for Medicinal Products for Human Use will soon begin its formal review of the MAA to make a recommendation to the European Commission, according to a July 19, 2024 company press release.

The MAA is based on interim results from two Phase III trials (DREAMM-7 and DREAMM-8), which both met their respective primary endpoints. The trials showed statistically significant and clinically meaningful improvements in progression-free survival for the belantamab mafodotin combinations compared to standard-of-care combinations in RRMM. The DREAMM-7 trial is evaluating the combination of belantamab mafodotin with BorDex versus daratumumab plus BorDex. The DREAMM-8 trial is evaluating the combination of belantamab mafodotin with PomDex versus bortezomib plus PomDex.

“[This] milestone reinforces the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after first relapse. We are working to bring Blenrep to patients as quickly as possible given the high unmet need and the clinically robust effects of the Blenrep combinations in the DREAMM-7 and DREAMM-8 [P]hase III head-to-head trials,” said Hesham Abdullah, senior vice-president, global head Oncology, R&D, GSK, in the press release.

Both Phase III trials also showed a positive overall survival (OS) trend, but the trend was not statistically significant at the time the interim analysis was conducted, according to the press release. Follow-up for OS is ongoing. Results did show clinically meaningful improvements across all other secondary efficacy endpoints, however, including deeper and more durable responses compared to respective standard-of-care therapy combinations. “The safety and tolerability profiles of the belantamab mafodotin combinations in DREAMM-7 and DREAMM-8 trials were broadly consistent with the known profiles of the individual agents,” GSK stated in the press release.

Multiple myeloma, the third most common blood cancer globally, is considered treatable but not curable (1,2). Approximately more than 180,000 new cases are diagnosed annually on a global basis. The diagnosis includes approximately 50,000 new cases in Europe (3).

Blenrep is an antibody-drug conjugate. The drug consists of a humanized B-cell maturation antigen monoclonal antibody (mAb) that is conjugated to auristatin F (cytotoxic agent) by a non-cleavable linker. According to GSK, the drug linker technology was licensed from Seagen. The mAb is produced using POTELLIGENT Technology, which was licensed from BioWa, a member of the Kyowa Kirin Group.

References

1. Sung, H.; Ferlay, J.; Siegel, R.; et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021,71 (3), 209–249. DOI:10.3322/caac.21660
2. Kazandjian, D. Multiple Myeloma Epidemiology and Survival: A Unique Malignancy. Semin. Oncol. 2016, 43 (6), 676–681. DOI:10.1053/j.seminoncol.2016.11.004
3. Ferlay, J.; Ervik, M.; Lam, F.; et al. Multiple Myeloma. In Global Cancer Observatory: Cancer Today; International Agency for Research on Cancer, 2024 [accessed July 23, 2024].

Source: GSK