China Approves BTD for Blenrep with BorDex in Multiple Myeloma

China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has awarded breakthrough therapy designation (BTD) to GSK's Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) for treating relapsed or refractory multiple myeloma. This designation is intended to speed up the development of therapies for severe and life-threatening conditions, particularly when there are limited existing treatments or where initial evidence suggests better patient outcomes compared to current options.

Hesham Abdullah, GSK’s global head for oncology research and development, emphasized the significance of this recognition in China, noting that it highlights the potential of Blenrep to revolutionize treatment outcomes for multiple myeloma patients. Abdullah expressed optimism about working with health authorities in China and around the world to make Blenrep-based combinations available to patients as quickly as possible.

The interim results of the Phase III DREAMM-7 trial, which achieved its primary endpoint, were instrumental in securing the BTD. The trial demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the combination of belantamab mafodotin and BorDex compared to the combination of daratumumab and BorDex in patients with relapsed or refractory multiple myeloma.

While the interim analysis showed a positive trend in overall survival (OS), it was not statistically significant at that stage. However, follow-up for overall survival is ongoing. The trial also showed clinically meaningful improvements in all secondary efficacy endpoints compared to the standard care combination. These secondary endpoints include overall survival, duration of response, and minimal residual disease negativity rate assessed through next-generation sequencing, as well as overall response rate, safety, and quality of life outcomes.

Safety and tolerability profiles for the belantamab mafodotin combination in the DREAMM-7 trial were consistent with those known for the individual agents involved. The trial, a multicenter, open-label, randomized study, evaluated the efficacy and safety of the belantamab mafodotin in combination with BorDex against a combination of daratumumab and BorDex. It involved patients with relapsed or refractory multiple myeloma who had undergone at least one previous line of treatment and whose disease had progressed during or after their most recent therapy.

A total of 494 participants were randomly assigned in a 1:1 ratio to either the belantamab mafodotin and BorDex combination or the daratumumab and BorDex combination. Blenrep, administered every three weeks at a dose of 2.5mg/kg intravenously, is an antibody-drug conjugate. It comprises a humanized B-cell maturation antigen monoclonal antibody linked to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen, while the monoclonal antibody is produced using Potelligent Technology licensed from BioWa, a member of the Kyowa Kirin Group.

Currently, Blenrep is approved as a monotherapy in Hong Kong, Israel, and Singapore. Multiple myeloma remains a growing health issue in China, with approximately 30,000 new cases diagnosed each year.