GSK’s Anti-BCMA ADC Belantamab Mafodotin Under Review for Priority Approval in China Based on Near Two-Year PFS Benefit in RRMM

Oct 15, 2024 10:11 CST Updated 10:11

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Today (October 15), the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China announced the latest information,Belantamab mafodotin injection, submitted by GSK, is proposed for inclusion in the priority review, targeting 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.. Publicly available information shows,Blenrep（belantamab mafodotin）Is aAntibody-drug conjugates (ADC) targeting B-cell maturation antigen (BCMA),It has been included by the CDE for the aforementioned indications.Breakthrough Therapy Drug.

In June this year, GSK announced Blenrep at the investor meeting 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 an ADC targeting BCMA, composed of a humanized anti-BCMA monoclonal antibody and the cytotoxic drug auristatin F linked by 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, treating patients with relapsed/refractory multiple myeloma who have previously received at least 4 therapies.

GSK is also exploringBlenrep 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 the risk of disease progression or death reduced by nearly 60% for patients on 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.。Moreover, 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 China Drug Clinical Trial and Information Disclosure Platform, GSK is currently 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 and 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, thisADC Therapy Targeting BCMA Proposed for Priority Review in China, Indicating Hope for Accelerated Access to Patients.

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Oct 15, 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

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