Blenrep Archives - Medical Design Sourcing

After withdrawal, GSK’s Blenrep shows promise in phase 3 DREAMM-7 study

In November 2022, GSK began the process of withdrawing Blenrep’s U.S. marketing authorization after the phase 3 DREAMM-3 trial failed to show an overall survival benefit compared to standard therapy. But GSK has signaled its hope that the B-cell maturation antigen (BCMA) antibody-drug conjugate could have a new lease on life with new data from the phase 3 DREAMM-7 study.

Blenrep shows promise in DREAMM-7 study as combination therapy

The study revealed that combining Blenrep (belantamab mafodotin) with the proteasome inhibitor bortezomib and the steroid dexamethasone (BorDex) improved progression-free survival by 59% compared to a combination of Darzalex (daratumumab) and BorDex. Additionally, progression-free survival was extended to 36.6 months with Blenrep plus BorDex, versus only 13.4 months with the daratumumab regimen. Finally, the DREAMM-3 study found an early but strong and clinically meaningful trend toward improved overall survival favoring the Blenrep …

Why GSK is pulling multiple myeloma drug Blenrep from U.S. market

FDA has requested that GSK plc (LSE/NYSE:GSK) withdraw the relapsed and refractory multiple myeloma drug Blenrep (belantamab mandolin-blmf) from the U.S. market.

GSK announced in a statement that it has initiated the process.

On November 7, the company announced that the drug did not meet its primary endpoint of progression-free survival (PFS) in the Phase 3 DREAMM-3 study. The humanized IgG1κ monoclonal antibody thus did not comply with FDA’s accelerated approval requirements.

In the study, Blenrep was pitted against Bristol Myers Squibb’s (Nasdaq:GILD), Pomalyst (pomalidomide) and dexamethasone.

GSK shares were up about a percentage point to $33.78.

The FDA approval covered patients with relapsed or refractory multiple myeloma treated with at least four earlier therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulator.

FDA notes that Blenrep is a first-in-class treatment.

GSK will …

GSK touts DREAMM clinical trial headway in multiple myeloma

GlaxoSmithKline (NYSE:GSK) will present 11 abstracts on Blenrep (belantamab mafodotin blmf) at the American Society of Hematology (ASH) Annual Meeting and Exposition on December 11–14. Presentations will include new data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial program and two collaborative studies focused on Blenrep.

The drug won FDA approval on August 5, 2020, for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies.

Featured presentations at ASH includes poster #2738, which will describe outcomes of regimen of belantamab mafodotin with the chemotherapies bortezomib and lenalidomide plus the steroid dexamethasone in transplant-ineligible patients with recently diagnosed multiple myeloma.

Another presentation will detail results from the BelaRd trial (poster #2736) from Hellenic Society of Hematology in collaboration with GSK exploring a similar cocktail mentione…