The U.S. Food and Drug Administration (FDA) has granted approval to daratumumab, administered concurrently with bortezomib, melphalan, and prednisone (VMP), for the treatment of patients with previously untreated multiple myeloma who are not candidates for autologous stem cell transplant (ASCT), according to a press release.1
The FDA based its approval on data from the phase 3 ALCYONE (MMY3007) study (ClinicalTrials.gov Identifier: NCT02195479), in which researchers randomly assigned 706 patients with newly diagnosed multiple myeloma to daratumumab plus VMP or VMP alone.
After a median follow-up of 16.5 months, results of the pre-specified interim analysis revealed that patients in the daratumumab arm had an overall response rate of 90.0% compared with 73.9% among patients in the control arm (P< .001). The rate of stringent complete response was significantly higher in the daratumumab arm (18% vs 7%), as well as the rate of complete response or better (42.6% vs 24.4%), compared with the control arm (P< .001).
The 18-month progression-free survival rate was 71.6% (95% CI, 65.5-76.8) among patients treated with daratumumab plus VMP compared with 50.2% (95% CI, 43.2-56.7) among patients treated with VMP alone (hazard ratio [HR], 0.50; 95% CI, 0.38-0.65; P< .001). The daratumumab group also had more than 3–fold improvement in minimal residual disease negativity with 22.3% compared with just 6.2% in the VMP alone arm (P< .001).
The most frequently reported grade 3 to 4 adverse effects included neutropenia, thrombocytopenia, anemia, infections, and infusion-related reactions.
Daratumumab was previously approved for patients with multiple myeloma who had previously failed 1 or more lines of therapy; in combination with VMP, it is now the first antibody-based treatment regimen approved as first-line therapy.
- Janssen announces Darzalex (daratumumab) US FDA approval for newly diagnosed patients with multiple myeloma who are transplant ineligible [news release]. Horsham, PA: PRNewswire; May 7, 2018. https://www.prnewswire.com/news-releases/janssen-announces-darzalex-daratumumab-us-fda-approval-for-newly-diagnosed-patients-with-multiple-myeloma-who-are-transplant-ineligible-300644142.html. Accessed May 8, 2018.
- Mateos MV, Dimopoulos MA, Cavo M, et al. Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma[published online February 8, 2018]. N Engl J Med. doi: 10.1056/NEJMoa1714678