GSK's Blenrep Receives Breakthrough Therapy Designation in China and Japan Review for Multiple Myeloma
核心洞察
GSK's Blenrep (belantamab mafodotin) gains Breakthrough Therapy Designation in China for relapsed or refractory multiple myeloma (搜索) when combined with bortezomib plus dexamethasone.
The designation is based on Phase III DREAMM-7 trial results, demonstrating statistically significant improvements in progression-free survival compared to daratumumab plus BorDex (搜索).
Japan's health authority also accepted Blenrep for review in combination with BorDex (搜索) or PomDex (搜索), supported by DREAMM-7 and DREAMM-8 trial data, offering new hope for patients.
GSK's Blenrep (belantamab mafodotin) has achieved significant regulatory milestones in China and Japan, marking advancements in the treatment of relapsed or refractory multiple myeloma (搜索). In China, the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation (BTD) to Blenrep when used in combination with bortezomib plus dexamethasone (BorDex (搜索)). Meanwhile, in Japan, the Ministry of Health, Labour and Welfare (MHLW) accepted Blenrep for review in combination with either BorDex or pomalidomide plus dexamethasone (PomDex (搜索)). These regulatory actions signal potential new treatment options for patients with multiple myeloma in these regions.
The BTD in China was based on interim results from the Phase III DREAMM-7 trial, a head-to-head study that demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) for belantamab mafodotin plus BorDex (搜索) compared to daratumumab plus BorDex in patients with relapsed or refractory multiple myeloma (搜索). The primary endpoint of PFS was met with a hazard ratio of 0.41 (95% CI, 0.31-0.53; P < .001), indicating a substantial reduction in the risk of disease progression or death.
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 (搜索) 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."
Rising Incidence of Multiple Myeloma
Multiple myeloma (搜索) is the third most common blood cancer globally, with over 180,000 new cases diagnosed each year. In China, approximately 30,000 new cases are reported annually, with incidence doubling and mortality increasing 1.5-fold in the past three decades. Similarly, in Japan, the number of patients diagnosed with multiple myeloma has been increasing, with over 7,200 new cases reported each year. These trends highlight the urgent need for novel and effective treatments for patients who progress on or become resistant to current standard-of-care therapies.
The acceptance of Blenrep for review in Japan is supported by data from the DREAMM-7 and DREAMM-8 Phase III trials. Both trials met their primary endpoints, demonstrating statistically significant and clinically meaningful improvements in PFS for belantamab mafodotin combinations compared to standard of care combinations in relapsed or refractory multiple myeloma (搜索).
DREAMM-7 and DREAMM-8 Trial Details
The DREAMM-7 trial (NCT04246047) is a multicenter, open-label, randomized trial evaluating the efficacy and safety of belantamab mafodotin in combination with BorDex (搜索) compared to a combination of daratumumab and BorDex in patients with relapsed/refractory multiple myeloma (搜索) who previously were treated with at least one prior line of multiple myeloma therapy. The primary endpoint is PFS as per an independent review committee. Key secondary endpoints include overall survival (OS), duration of response (DOR), and minimal residual disease (MRD) negativity rate.
The DREAMM-8 trial (NCT04484623) is a multicenter, open-label, randomized trial evaluating the efficacy and safety of belantamab mafodotin in combination with PomDex (搜索) compared to a combination of bortezomib and PomDex in patients with relapsed/refractory multiple myeloma (搜索) previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen. The primary endpoint is PFS as per an independent review committee. Key secondary endpoints include OS and MRD negativity rate.
About Blenrep
Blenrep is an antibody-drug conjugate comprising a humanised B-cell maturation antigen (BCMA (搜索)) 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. The regulatory actions in China and Japan, if successful, could expand the availability of Blenrep-based combinations to a broader patient population, addressing a critical unmet need in the treatment of relapsed or refractory multiple myeloma (搜索).