GSK Submits NDA in China for Belantamab Mafodotin, a Potential Blockbuster BCMA-Targeted ADC for Relapsed/Refractory Multiple Myeloma

Dec 07, 2024 08:23 CST Updated 08:23

GSK

Pharmaceutical R&D Manufacturer

▎WuXi AppTec Content Team Report

Today (December 6), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) shows,GSK's submission of the marketing application for Maralixibat injection has been accepted. According to public information, this is a GSK-developedBlenrep（belantamab mafodotin），Is aAntibody-Drug Conjugates (ADC) Targeting B-Cell Maturation Antigen (BCMA). The product has been previously included in the CDE's priority review andBreakthrough Therapy Drug, for the indication ofIn combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.。

In June this year, GSK announced Blenrep at the investor conference forRelapsed or Refractory Multiple Myeloma (RRMM)Second-line and subsequent treatmentsTheTwo items 3Phase TrialImpressive results. In the DREAMM-7 study, the median progression-free survival (PFS) for patients receiving Blenrep combination therapy was 36.6 months.Nearly 2 years longer than the active control group, and the complete remission rate was more than twice that of the control group.GSK emphasized at the meeting that Blenrep is a potential blockbuster drug with the possibility of becoming the standard treatment for RRMM patients in the 2nd line and beyond.

Screenshot source: CDE official website

Blenrep is a BCMA-targeted ADC,Composed of a humanized anti-BCMA monoclonal antibody and the cytotoxic drug auristatin F (auristatin F) conjugated via a non-cleavable linker., which can eliminate myeloma cells through multiple mechanisms of action. The drug received FDA approval in the United States in August 2020.Accelerated Approval, for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 4 prior therapies.

GSK is also exploringBlenrep is used to treat more types of multiple myeloma patients.In June this year, GSK announced BlenrepTwo Phase 3 TrialsResults of the DREAMM-7 and DREAMM-8 studies. Among them,DREAMM-7Evaluated Blenrep in combination with bortezomib and dexamethasone (BorDex), compared with the current standard of care (DaratumumabAdd BorDex) In comparison, as RRMM patientsSecond-line and subsequent treatmentsEfficacy in China. This is preciselyThe indication for which Blenrep is proposed to be included in the priority review in China.

DREAMM-7 Study Meets Primary Endpoint，The median progression-free survival (PFS) for patients receiving Blenrep combination therapy was 36.6 months, nearly two years longer than the 13.4 months observed in the active control group, with a nearly 60% reduction in the risk of disease progression or death for patients receiving Blenrep combination therapy.。For the key secondary endpoint of overall survival (OS), the median OS for both groups has not yet been reached,But Blenrep combination therapy has shown early, significant clinical benefits.。In addition, the Blenrep combination therapy also outperformed the active control group in terms of depth of response.The proportion of patients treated with Blenrep combination therapy who achieved complete response (CR) was more than twice that of the control group.

According to the official website of the Chinese Drug Clinical Trial and Information Disclosure Platform, GSK is conducting three international multicenter (including China) Phase 3 clinical trials for this product.Including one of the aforementionedDREAMM-7 Study, and:

DREAMM 8 Study, aiming toEvaluation of Blenrep in CombinationPomalidomideEfficacy of Dexamethasone (PomDex) Combined with Standard Treatment Bortezomib Plus PomDex as Second-line and Later Therapies for RRMM Patients.
DREAMM 3 Study, aimed at patients who have received more than 2 lines of treatmentEvaluation in RRMM ParticipantsBlenrepEfficacy and Safety of Monotherapy Compared with Pomalidomide Plus Low-Dose Dexamethasone (pom/dex).

This time, thisThe ADC therapy targeting BCMA has been submitted for marketing approval in China, indicating that the product may benefit more patients in the near future.

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Dec 7, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the European Medicines Agency. Retrieved July 22, 2024, from https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-in-multiple-myeloma-application-accepted-for-review-by-the-european-medicines-agency/

[3] Meet GSK management Oncology Getting ahead of cancer. Retrieved June 18, 2024 from chrome- https://www.gsk.com/media/11251/getting-ahead-of-oncology-presentation.pdf

This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media platforms, but unauthorized republication by media or organizations in any form to other platforms is prohibited. For reprint authorization and other cooperation inquiries, please contact wuxi_media@wuxiapptec.com.

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it imply that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.