GlaxoSmithKline reports positive results for its relapsed/refractory multiple myeloma candidate.

 Multiple myeloma is the second most common blood cancer in the United States. While it is considered to be treatable, no cure has yet been developed. Relapses are common and more difficult to treat.

GlaxoSmithKline (GSK) is hopeful that its investigational anti-B-cell maturation antigen (BCMA) antibody–drug conjugate GSK2857916 will provide patients with a new treatment option. GSK2857916 comprises a humanized BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The candidate has received breakthrough therapy designations from the U.S. Food and Drug Administration and priority review from the European Medicines Agency.

Recently, GSK reported (https://www.gsk.com/en-gb/media/press-releases/gsk-announces-further-positive-data-from-dreamm-1-study-of-anti-bcma-antibody-drug-conjugate/) results from part 2 of its DREAMM-1 study of 35 patients with relapsed/refractory multiple myeloma that received GSK2857916. DREAMM-1 is a first-in-human, open-label study intended to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity and clinical activity of GSK2857916 in patients with relapsed/refractory multiple myeloma expressing BCMA. Part 1 was a dose-escalation phase, while part 2 was a dose-expansion phase.

In part 2 of the DREAMM-1 study, 60% of patients receiving GSK2857916 achieved an overall response rate (ORR) identical to that reported in the interim analysis after more than a year of follow-up. Notably, the number of patients achieving a complete response increased to 15% during the additional one-year follow-up period. In addition, the median progression-free survival increased from 7.9 to 12 months. Importantly, no new safety signals were identified during this treatment period.

GSK is currently conducting several clinical trials with GSK2857916 in relapsed/refractory multiple myeloma and other advanced hematologic malignancies expressing BCMA.