GlaxoSmithKline PLC's experimental drug GSK2857916 lowered the levels of blood cancer in certain patients during an early-stage study.
The phase 1/2 study, named Dreamm-1, showed that the drug lowered the levels of disease in 60% of patients in the trial with multiple myeloma whose cancer had returned or was not responding to treatment. This data was identical to what was seen in a prior interim analysis , after more than a year of follow-up.
Multiple myeloma is an incurable blood cancer that forms in plasma cells — a type of white blood cell — that are responsible for producing antibodies. The disease, which is the second most common blood cancer in the U.S., is characterized by a recurring pattern of remission and relapse.
GSK2857916 is an investigational anti-B-cell maturation antigen, or BCMA, antibody-drug conjugate. The normal function of BCMA is to promote plasma cell survival, but it has been shown at high levels to be important for myeloma cell growth and survival.
GSK's drug works by binding to the BCMA on the surface of the tumor cell and restricts certain chemical processes, which in turn result in the death of the tumor cell and inhibits replication of tumor cells that overexpress BCMA.
In addition, data from the trial showed that 15% of patients treated with GSK2857916 had no detectable levels of cancer over the additional one year follow-up period. The results also showed that patients were able to survive for a median of 12 months without the disease worsening, up from 7.9 months reported in the interim analysis.
A total of 35 heavily pre-treated patients were enrolled in part 2 of the Dreamm-1 study independent of BCMA levels in their system. In this part of the study, 71% of patients who had not been previously treated with Johnson & Johnson's Darzalex, or daratumumab, saw a reduction in levels of multiple myeloma. Meanwhile, only 38.5% of patients who had previously received Darzalex experienced a reduction in their cancer.
The U.S. Food and Drug Administration and the European Medicines Agency granted the drug breakthrough therapy and PRIME designations, respectively, in 2017.