Daratumumab Combination Approved for Transplant-Eligible Patients With Multiple Myeloma
Posted: Monday, September 30, 2019
On September 26, 2019, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with bortezomib, thalidomide, and dexamethasone for newly diagnosed adult patients with multiple myeloma who are eligible for autologous stem cell transplantation.
Efficacy was investigated in CASSIOPEIA (ClinicalTrials.gov identifier NCT02541383), an open-label, randomized, active-controlled phase III study comparing induction and consolidation treatments with daratumumab in combination with bortezomib, thalidomide, and dexamethasone with bortezomib, thalidomide, and dexamethasone alone in patients with newly diagnosed multiple myeloma who were eligible for autologous stem cell transplantation.
The trial demonstrated an improvement in progression-free survival in the daratumumab arm compared with the nondaratumumab arm. Treatment with the daratumumab combination therapy resulted in a reduction in the risk of disease progression or death by 53% compared with bortezomib, thalidomide, and dexamethasone alone. The stringent complete response rate at day 100 after autologous stem cell transplantation was 28.9% in the daratumumab arm and 20.3% in the arm without daratumumab.
In patients with newly diagnosed multiple myeloma who received daratumumab in combination with bortezomib, thalidomide, and dexamethasone, the most frequent (≥ 20%) adverse reactions were infusion reactions, peripheral sensory neuropathy, constipation, asthenia, nausea, peripheral edema, neutropenia, thrombocytopenia, pyrexi,a and paresthesia. Adverse reactions that occurred with at least 5% greater frequency in the daratumumab arm were infusion reactions, nausea, neutropenia, thrombocytopenia, lymphopenia, and cough. There were no significant differences in the number or type of serious adverse events in the two treatment arms.
