New drug for multiple myeloma approved in China, reducing patient mortality risk by 42%

GlaxoSmithKline announced on April 20th that Beilei Rui ® Mabelantuzumab for injection has been approved in China for use in adult patients with multiple myeloma who have received at least first-line treatment in the past. Clinical studies have shown that the combination therapy of this drug can reduce the risk of death by 42% and prolong the median progression free survival by nearly three times, bringing new hope for the treatment of recurrent multiple myeloma patients.

Multiple myeloma is the third most common blood cancer worldwide and is generally considered a treatable but incurable disease. In the past three decades, the incidence rate of multiple myeloma in China has doubled, with about 30000 new cases and 50% more deaths each year. A prominent feature of this disease is its tendency to relapse, and often leads to resistance to existing treatments after relapse, resulting in extremely limited treatment options. For patients who have already received first-line treatment, how to delay disease progression and prolong survival is an urgent issue in clinical practice.

The approved injectable Mabelantuzumab is an antibody conjugated drug (ADC) that targets the B cell mature antigen (BCMA). It is currently the only anti BCMA therapy approved in China for the treatment of second-line and above multiple myeloma. Its approval is based on a phase III clinical study called -7. This study compared the efficacy of the combination therapy of Mabelantuzumab for injection with bortezomib and dexamethasone (BVd regimen) and the combination therapy of Daretumumab (DVd regimen) head to head. The results showed that the median progression free survival in the BVd group reached 36.6 months, nearly three times that of the DVd group (13.4 months); The risk of death decreased by 42%, with a three-year overall survival rate of 74% in the BVd group and 60% in the DVd group. In terms of safety, research has confirmed that the ocular side effects associated with injectable Mabelantuzumab can be effectively managed through appropriate dosage adjustments and follow-up, as the incidence of discontinuation of ocular side effects does not exceed 9%.

Hesham Abdullah, Senior Vice President and Global Head of Oncology at GlaxoSmithKline, said, "This time, Beilei Rui ® Approved in China, it provides a new option for anti BCMA treatment for recurrent or refractory multiple myeloma patients receiving second-line or higher treatment. Its differentiated mechanism of action is expected to delay disease progression and prolong patient survival. In addition, as the only anti BCMA antibody conjugated drug (ADC) currently available, Beilei Rui ® It can be used throughout the outpatient process without the need for complex medication preparation plans or hospitalization treatment, and can be used in different treatment scenarios