▎WuXiEdited by Kant Content Team

Recently, GSK announced at its investor meeting the impressive results of its antibody-drug conjugate (ADC) Blenrep (belantamab mafodotin) 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 treatment for RRMM patients in the 2nd line and beyond!

DREAMM-7 evaluates the efficacy of Blenrep in combination with bortezomib and dexamethasone (BorDex) compared to the current standard treatment regimen (daratumumab plus BorDex) for RRMM patients as a 2nd-line and later treatment option.The analysis shows,The median progression-free survival (PFS) for patients receiving Blenrep combination therapy (N=243) was 36.6 months (95% CI: 28.4-NR), nearly two years longer than the 13.4 months (95% CI: 11.1-17.5) observed in patients in the active control group (N=251). The risk of disease progression or death was reduced by nearly 60% in patients receiving Blenrep combination therapy.（HR：0.41，95% CI：0.31-0.53, p<0.00001), achieving the primary endpoint of this trial.

▲PFS Results of the DREAMM-7 Phase 3 Clinical Trial (Image Source: Reference [1])

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 demonstrated early, significant clinical benefits (HR: 0.57, 95% CI: 0.40-0.80, p=0.00049)., The follow-up for OS is still ongoing. Notably, 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.

▲OS Results of DREAMM-7 Phase 3 Clinical Trial (Image Source: Reference [1])

▲The proportion of patients receiving Blenrep combination therapy who achieved complete remission was more than twice that of the control group (Image source: Reference [1]).

The Phase 3 DREAMM-8 head-to-head trial evaluates the efficacy of Blenrep in combination with pomalidomide and dexamethasone (PomDex) versus the standard treatment of bortezomib plus PomDex as a 2nd-line and later therapy for patients with RRMM. The analysis shows,The median PFS for patients receiving Blenrep combination therapy (N=155) has not yet been reached (95% CI: 20.6-NR), compared to 12.7 months (95% CI: 9.1-18.5) for patients in the active comparator group (N=147). The risk of disease progression or death was reduced by nearly 50% in patients receiving Blenrep combination therapy.(HR: 0.52, 95% CI: 0.37-0.73, p<0.001), achieving the primary endpoint of this trial. Additionally, the Blenrep combination therapy demonstrated benefits across all pre-specified subgroup analyses.

▲PFS Results of the DREAMM-8 Phase 3 Clinical Trial (Image Source: Reference [1])

As for the key secondary endpoint OS, the median OS for patients in both groups has not yet been reached,However, the Blenrep combination therapy has shown a trend of superiority over the active control drug (HR: 0.77, 95% CI: 0.53-1.14)., Follow-up for OS is still ongoing.Notably, the Blenrep combination therapy also demonstrates significant depth in relief.Superior 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.

▲OS Results of DREAMM-8 Phase 3 Clinical Trial (Source: Reference [1])

▲The proportion of patients achieving complete response with Blenrep combination therapy more than doubled that of the control group (Image source: Reference [1])

Blenrep is an ADC targeting B-cell maturation antigen (BCMA), composed of a humanized anti-BCMA monoclonal antibody and the cytotoxic drug auristatin F, conjugated via 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``, becoming the world's first approved therapy targeting BCMA.``

References:

[1] 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

[2] GSK Reignites Blenrep Blockbuster Aspirations With Data from Phase III Studies. Retrieved June 18, 2024 from https://www.biospace.com/article/gsk-reignites-blenrep-blockbuster-aspirations-with-data-from-phase-iii-studies-/

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