Daratumumab significantly improved survival when added to the current two-drug regimen for multiple myeloma, according to published data from a phase III study.
Patients treated with the anti-CD38 antibody in addition to the current standard treatment combination of bortezomib and dexamethasone had a 61% progression-free survival rate compared with a 27% rate seen in controls who received only bortezomib and dexamethasone.
The study results were presented initially at the annual meeting of the American Society of Hematology in 2015.
After an average follow-up of 7 months, 67 disease-progression events or deaths occurred in the daratumumab group, compared with 122 in the control group. Overall treatment response rates also were significantly higher in the daratumumab group compared with controls (83% vs. 63%), reported Antonio Palumbo, MD, of the University of Turin, Italy, and his associates in the CASTOR study.
The multicenter, randomized trial included 251 multiple myeloma patients in the daratumumab group 247 patients in the control group. Demographics were similar between the groups; the median patient age was 64 years.
Although more than 95% of patients in each group reported at least one adverse event, fewer than 10% of patients in each group discontinued treatment as a result. The most common adverse events associated with discontinuation were peripheral sensory neuropathy and pneumonia (N Engl J Med 2016;375:754-66).
The study was funded by Janssen Research and Development.