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ASH 2018: Daratumumab Combination Therapy in Newly Diagnosed Multiple Myeloma

By: Sarah Campen, PharmD
Posted: Wednesday, December 5, 2018

The addition of daratumumab to a lenalidomide-based treatment regimen appears to significantly improve survival in patients with newly diagnosed multiple myeloma who are ineligible for transplant. In fact, the combination therapy reduced the risk of disease progression or death by 45%. Thierry Facon, MD, of Lille University Hospital, France, and colleagues presented the results of the phase III MAIA study at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract LBA-2).

The combination of daratumumab to a lenalidomide-based treatment “certainly has the potential to change the upfront therapy of newly diagnosed myeloma and the transplant-ineligible patients,” stated Robert Rifkin, MD, FACP, of Rocky Mountain Cancer Center, during a news briefing prior to the ASH Annual Meeting.

The study included 737 patients who were ineligible for high-dose chemotherapy with autologous stem cell transplantation (due to age of 65 or older or comorbidities). A total of 44% of patients were at least 75 years old. Participants were randomly assigned 1:1 to receive treatment with lenalidomide and dexamethasone with or without daratumumab.

At the interim analysis, with a median follow-up of 28 months, a hazard ratio of 0.55 (P < .0001) indicated a 45% decrease in the risk of disease progression or death for patients in the daratumumab arm. Adding daratumumab also resulted in “deeper responses,” with a complete response or better observed in 47.6% of patients treated with daratumumab compared with 24.7% of those treated with lenalidomide and dexamethasone alone. No new safety signals were reported for the daratumumab arm, but higher rates of grade 3 or 4 pneumonia, neutropenia, and leukopenia were observed.



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