The novel antibody product daratumumab (Darzalex, Genmab/Janssen) has been approved by the US Food and Drug Administration for first-line use in the treatment of newly diagnosed multiple myeloma in patients who are ineligible for an autologous stem cell transplant (ASCT).
Daratumumab is indicated for first-line use together with the standard triplet of bortezomib (Velcade, Millenium), mephalan, and prednisone (VMP).
The drug is already approved for use in the treatment of relapsed/refractory multiple myeloma, in various drug combinations, and has recently been described as a new standard of care in this setting
The approval for the latest indication of first-line use is based on results from the phase 3 ALCYONE study (NCT02195479), which was presented at the 2017 annual meeting of the American Society of Hematology (ASH) and simultaneously published in the New England Journal of Medicine, as reported at the time by Medscape Medical News.
The study was conducted in 706 newly diagnosed patients with multiple myeloma who were ineligible for ASCT and who were randomly assigned to receive treatment with either daratumumab plus VMP (D-VMP) or VMP alone.
The results show that the addition of the antibody extended progression-free survival (PFS).
At a median follow-up of 16.5 months, the hazard ratio for PFS (D-VMP vs VMP) was 0.50 (P < .0001), which represented a 50% reduction in the risk for progression or death for the D-VMP cohort, the researchers reported at the meeting.
Median PFS was not reached in the D-VMP group (with up to 27 months of follow-up) and was 18.1 months in the VMP group.
These findings were consistent across all prespecified subgroups, including patients age 75 years or older and patients with high-risk cytogenetics.
The most common grade 3/4 treatment emergent adverse events for D-VMP vs VMP were neutropenia (39.9% vs 38.7%), thrombocytopenia (34.4% vs 37.6%), anemia (15.9% vs 9.8%), and pneumonia (11.3% vs 4.0%; one patient in each group stopped treatment because of pneumonia).
At the ASH meeting, an expert approached for comment, Ajai Chari, MD, PhD, associate professor of medicine and director of clinical research in the Multiple Myeloma Program at Mt Sinai Health System, New York, City, said, “We may be now looking at an alternative therapy for front-line treatment, in those who are ineligible for transplantation.”
While some patients may prefer drug therapy over a transplant, Dr Chari cautioned that these results do not speak to that issue. “This study will not answer the question of whether quadruple therapy will replace transplant because the population in this study is transplant ineligible,” he said. “That study will have to be done, to address the question of quadruple therapy as an alternative to transplant.”
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