By Reuters Staff
(Reuters Health) - 31/5/2019
More than two years after treatment, patients with newly-diagnosed multiple myeloma fare better with daratumumab added to the standard therapy of lenalidomide plus dexamethasone instead of standard therapy alone, according to published results from the MAIA study of 737 volunteers.
The rate of disease progression or death after a median follow-up of 28.0 months was 38.8% in the control group versus 26.4% with the three-drug combination known as DaraLenDex. The hazard ratio reduction was 44% (P<0.001).
Nearly 13,000 people in the U.S. die from multiple myeloma each year.
Janssen, which sells the drug under the brand name Darzalex, paid for the study. The U.S. Food and Drug Administration approved daratumumab -- in combination with three other drugs -- for newly-diagnosed multiple myeloma just over a year ago after it produced a 50% reduction in disease progression or death. That treatment is supposed to be for patients who are not eligible for an autologous stem cell transplant. The MAIA study involved a similar group of patients.
The MAIA team estimated that 70.6% of the DaraLenDex patients would be alive without disease progression at 30 months versus 55.6% with LenDex alone.
The rate of complete response or better was 47.6% with daratumumab and 24.9% without.
However, the rate of grade 3 or 4 neutropenia was 50.0% with daratumumab versus 35.3% in the control group. Lymphopenia and pneumonia were also significantly more common. Anemia was less common.
The findings, published in the May 30 edition of the New England Journal of Medicine, were unveiled in December at the annual meeting of the American Society of Hematology. The drug costs about $135,000 per year according to the website FiercePharma.
N Engl J Med 2019.