ADC Digest - August 2020

ADC Digest - August 2020

FDA approved GSK’s BLENREP (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma

06 Aug 2020

BLENREP (belantamab mafodotin-blmf, Tubulin polymerisation inhibitors; GSK)

  • Approved as monotherapy for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent
  • Approved under accelerated approval based on response rate
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials
  • The approval of BLENREP was based on the 6-month primary results from the pivotal DREAMM-2 study
  • Seattle Genetics achieved milestone payment under antibody-drug conjugate collaboration with GSK triggered by BLENREP FDA approval

BLENREP became the first anti-BCMA therapy approved anywhere in the world

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Our outlook: 

  • FDA approved GSK’s BLENREP, a first-in-class anti-BCMA under accelerated pathway based on the response rates from DREAMM-2 study
  • Multiple myeloma is often associated with poor patient outcomes due to the development of acquired resistance with the current SoC
  • BLENREP – a new option for relapsed or refractory multiple myeloma patients who have failed multiple lines of treatment

– Dr. Kowndinya, CI Scientists

Background:

  • BLENREP is a BCMA (B-cell maturation antigen) targeting antibody drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker
  • BLENREP employs a multi-faceted mechanism of action and is directed toward BCMA, a cell-surface protein that plays an important role in the survival of plasma cells and is expressed on multiple myeloma cells
  • The pivotal DREAMM-2 study demonstrated treatment with a single-agent BLENREP 2.5 mg/kg every three weeks shown clinically meaningful ORR of 31% (97.5% CI; 21-43) in patients who had received a median of seven prior lines of treatment (n=97)

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