GSK's Blenrep (belantamab mafodotin), in combination with bortezomib plus dexamethasone (BorDex), has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of relapsed or refractory multiple myeloma. This designation aims to expedite the development of therapies for serious conditions where current treatments are lacking or show limited improvement in patient outcomes.
The BTD was granted based on interim results from the Phase III DREAMM-7 trial, a head-to-head study comparing the Blenrep combination to daratumumab plus BorDex in patients with relapsed or refractory multiple myeloma. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the Blenrep arm.
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, stated, "Breakthrough Therapy Designation in China underscores the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after their first relapse. We look forward to continuing to work with the health authority in China and others worldwide to bring Blenrep-based combinations to patients as expeditiously as possible."
DREAMM-7 Trial Details
The DREAMM-7 trial is a multicenter, open-label, randomized Phase III study evaluating the efficacy and safety of belantamab mafodotin in combination with BorDex versus daratumumab and BorDex in patients with relapsed/refractory multiple myeloma who have received at least one prior line of therapy and have documented disease progression. The trial randomized 494 participants in a 1:1 ratio.
Belantamab mafodotin was administered intravenously at 2.5mg/kg every three weeks. The primary endpoint was PFS, assessed by an independent review committee. Key secondary endpoints included overall survival (OS), duration of response (DOR), and minimal residual disease (MRD) negativity rate, as determined by next-generation sequencing. Other secondary endpoints included overall response rate (ORR), safety, and patient-reported quality of life outcomes.
Clinical Significance
While a positive trend in overall survival (OS) was observed, it did not reach statistical significance at the interim analysis. Follow-up for OS is ongoing. The trial also demonstrated clinically meaningful improvements across other secondary efficacy endpoints, including deeper and more durable responses compared to the standard-of-care combination. The safety and tolerability profile of the belantamab mafodotin combination was consistent with the known profiles of the individual agents.
Multiple Myeloma in China
Multiple myeloma is a growing concern in China, with approximately 30,000 new cases diagnosed annually. The incidence of multiple myeloma in China has doubled, and mortality has increased 1.5-fold in the past three decades, highlighting the urgent need for effective treatment options, especially for patients with disease progression resistant to current standards of care.
Multiple myeloma, the third most common blood cancer globally, is generally treatable but not curable. Approximately 180,000 new cases are diagnosed worldwide each year. The disease often becomes refractory to available treatments, necessitating ongoing research into novel therapies.
About Blenrep
Blenrep is an antibody-drug conjugate (ADC) comprising a humanized B-cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. It is approved as monotherapy in Hong Kong, Israel, and Singapore.
