FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has approved the use of daratumumab (Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (Revlimid) and a proteasome inhibitor.  

“We are very pleased to receive the FDA’s decision to approve daratumumab in combination with pomalidomide and dexamethasone. This offers another alternative to patients with multiple myeloma who haven’t seen lasting effects from other types of treatment,” said Jan van de Winkel, PhD, Chief Executive Officer of Genmab.

The approval was based on data from the phase I (MMY1001, EQUULEUS) study of daratumumab in combination with pomalidomide and dexamethasone in relapsed or refractory multiple myeloma.  

About the EQUULEUS study

One arm of the phase I EQUULEUS open-label study included 103 patients with multiple myeloma who had received prior treatment with a proteasome inhibitor and an immunomodulatory agent. Patients in the study received 16 mg/kg of daratumumab in combination with pomalidomide and dexamethasone. 

The overall response rate in the study was 59% (95% confidence interval [CI] = 49.1%–68.8%), with very good partial response achieved in 28% of patients. Complete response was achieved in 6% of patients and stringent complete response was achieved in 8% of patients.  The median time to response was 1 month (range = 0.9–2.8 months). The median duration of response was 13.6 months (range = 0.9+ to 14.6+ months).

The most frequent adverse reactions (> 20%) in the study were infusion reactions (50%), diarrhea (38%), nausea (30%), vomiting (21%), fatigue (50%), pyrexia (25%), upper respiratory tract infection (50%), muscle spasms (26%), cough (43%), and dyspnea (33%). The overall incidence of serious adverse reactions was 49%.

Serious adverse reactions (grade 3/4) reported in ≥ 5% patients included pneumonia (7%). The most common treatment-emergent hematology laboratory abnormalities were lymphopenia (94%), neutropenia (95%), thrombocytopenia (75%), and anemia (57%). The most common grade 3/4 treatment-emergent hematology laboratory abnormalities were neutropenia (82%), lymphopenia (71%), anemia (30%), and thrombocytopenia (20%).

The median age of patients in the study was 64 years, with 8% of patients older than 75. Patients in the study had received a median of four prior lines of therapy, and 74% of patients had received prior autologous stem cell transplant. Eighty-nine percent of patients were refractory to lenalidomide, and 71% were refractory to bortezomib (Velcade); 64% of patients were refractory to bortezomib and lenalidomide.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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