ASH 2020: Subcutaneous Daratumumab Plus Pomalidomide and Dexamethasone in Resistant Myeloma
Posted: Tuesday, December 15, 2020
The addition of subcutaneous daratumumab to pomalidomide and dexamethasone appears to significantly reduce the risk of disease progression or death by 37% in patients with relapsed or refractory multiple myeloma compared with pomalidomide plus dexamethasone alone. These findings from a primary analysis of the phase III APOLLO study were presented during the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 412).
The authors reported a “very low” rate of infusion-related reactions with subcutaneous administration of daratumumab.
“Collectively, these data show that [daratumumab plus pomalidomide and dexamethasone] is an effective and convenient treatment for patients with relapsed/refractory multiple myeloma who received ≥ 1 prior therapy, including lenalidomide and a proteasome inhibitor,” stated Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, Greece, and colleagues.
In this open-label study, 304 patients who had received at least one prior line of therapy were randomly assigned to receive either subcutaneous daratumumab plus pomalidomide and dexamethasone (n = 151) or pomalidomide and dexamethasone (n = 153). In all, 79.6% of patients were refractory to lenalidomide, 48.0% were refractory to a proteasome inhibitor, 42.4% were refractory to both.
Following a median duration of treatment of 11.5 months with daratumumab and 6.6 months with the control, the study met its primary endpoint of improved progression-free survival: the hazard ratio was 0.63 (P = .0018). The median progression-free survival for the daratumumab and control arms was 12.4 and 6.9 months, respectively. A total of 99 patients (33%) died after a median follow-up of 16.9 months.
As for safety, the most common grade 3 or 4 adverse events with a > 5% difference between the daratumumab and control arms included neutropenia (68% vs. 51%), leukopenia (17% vs. 5%), and lymphopenia (12% vs. 3%).
Disclosure: For full authors’ disclosures, visit ash.confex.com.
