▎WuXi AppTec Content Team Report

In June this year, GSK announced at an investor meeting the impressive results of Blenrep in two Phase 3 trials, DREAMM-7 and DREAMM-8, for the treatment of relapsed or refractory multiple myeloma (RRMM). GSK emphasized at the meeting that Blenrep is a potential blockbuster drug with the possibility of becoming the standard therapy for RRMM patients in second-line and subsequent treatments.

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 together by a non-cleavable linker., which can eliminate myeloma cells through multiple mechanisms of action. The drug received Breakthrough Therapy Designation from the U.S. FDA in 2017 and obtained FDA approval in August 2020.Accelerated Approval, for the treatment of relapsed/refractory multiple myeloma patients who have previously received at least four types of therapies. According to GSK's press release at the time, this is the world's first approved BCMA-targeted therapy.

In June this year, GSK announced BlenrepTwo Phase 3 TrialsResults from the DREAMM-7 and DREAMM-8 studies. Among these, DREAMM-7 evaluated the combination of Blenrep with bortezomib and dexamethasone (BorDex) compared to the current standard of care (DaratumumabCompared with adding BorDex, the efficacy in the 2nd-line and subsequent treatments for RRMM patients.

The analysis shows,The median progression-free survival (PFS) for patients receiving Blenrep combination therapy (N=243) was 36.6 months, nearly two years longer than the 13.4 months observed in the active comparator group (N=251). The risk of disease progression or death was reduced by nearly 60% in patients receiving Blenrep combination therapy., achieving the primary endpoint of the trial.

As 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.

DREAMM-8 Phase 3 Head-to-Head Trial Evaluates Blenrep in CombinationPomalidomideEfficacy of Dexamethasone (PomDex) Plus Standard Treatment Bortezomib and PomDex as Second-Line and Later Therapies for RRMM Patients. Analysis showed that the median PFS for patients receiving Blenrep combination therapy (N=155) has not been reached, while the PFS for the active control group (N=147) was 12.7 months.Blenrep Combination Therapy Reduces Risk of Disease Progression or Death by Nearly 50%, achieving the primary endpoint of this trial. In addition,Blenrep Combination Therapy Also Shows Deep RemissionSuperior to the active control group,The proportion of patients receiving Blenrep combination therapy who achieved complete remission was more than twice that of the control group.

In May 2022, GSK announcedBlenrepLanding in Boao Lecheng Pilot Zone, Hainan, for the treatment of multiple myeloma. According to the official website of the China Drug Clinical Trial and Information Disclosure Platform, GSK is conducting two clinical studies, including a Phase 1 study in China to evaluate the impact of belantamab mafodotin on Chinese subjects with relapsed/refractory multiple myeloma; and a Phase 3 study to evaluate belantamab mafodotin in combination with pomalidomide and dexamethasone compared to pomalidomide plus bortezomib and dexamethasone in treating subjects with relapsed/refractory multiple myeloma.

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Sep 2, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c