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FDA Grants Priority Review to Frontline Daratumumab for Multiple Myeloma

Silas Inman @silasinman
Published: Monday, Jan 22, 2018

Jan van de Winkel, PhD
Jan van de Winkel, PhD
The FDA has granted a priority review designation to daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The designation was based on findings from the ALCYONE study, which were published in the New England Journal of Medicine and presented at the 2017 ASH Annual Meeting.1,2

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The most common hematologic adverse events (AEs) of grade 3/4 severity with the daratumumab combination versus VMP alone, respectively, were neutropenia (39.9% vs 38.7%), thrombocytopenia (37.6% vs 34.4%), and anemia (19.8% vs 15.9%). The most common grade 3/4 nonhematologic AEs for daratumumab versus VMP, respectively, were peripheral sensory neuropathy (1% vs 4%), diarrhea (3% each), and pneumonia (11% vs 4%). Infusion-related reactions occurred in 27.7% of patients in the daratumumab group.

The rate of grade 3/4 infection was 23.1% for daratumumab compared with 14.7% for VMP alone. Infections led to treatment discontinuation for 1.4% of patients in the VMP group and 0.9% in the daratumumab group. Serious AEs occurred in 41.6% of patients in the daratumumab arm and for 32.5% of patients in the VMP group. AEs led to discontinuation for 4.9% of patients in the daratumumab group versus 9.0% for the control arm.

"ALCYONE strongly supports daratumumab-VMP as a standard of care in transplant-ineligible newly diagnosed multiple myeloma," lead investigator Maria-Victoria Mateos, MD, PhD, director of the Myeloma Unit at University Hospital of Salamanca-IBSAL Salamanca, Spain, said during a presentation of the results at the 2017 ASH Annual Meeting. "Daratumumab plus VMP reduced the risk of progression or death and induced significantly deeper responses. There were no new safety signals observed except for higher infection events that resolved."

In November 2016, the FDA approved daratumumab in combination with lenalidomide (Revlimid) and dexamethasone or bortezomib and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy. This indication was based on a 61% to 63% reduction in the risk of progression or death in the phase III CASTOR and POLLUX trials.

The agent continues to be explored across several clinical trials, including the phase III CASSIOPEIA study, which is looking at the daratumumab in combination with bortezomib, thalidomide, and dexamethasone for untreated transplant-ineligible patients with multiple myeloma (NCT02541383). Additionally, a subcutaneous administration route of the intravenous medication is also being explored in a phase III trial (NCT03277105). 
References
  1. Mateos M-V, DA Meletios, Cavo M, et al. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. 2017. DOI:10.1056/NEJMoa1714678.
  2. Mateos M-V, DA Meletios, Cavo M, et al. Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) in Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Ineligible for Transplant (ALCYONE). Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2017; Atlanta, Georgia. Abstract LBA-4.

 



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