Subcutaneous daratumumab with pomalidomide and dexamethasone (D-Pd) is an effective and convenient treatment for patients with relapsed or refractory multiple myeloma who have received at least one line of therapy, including lenalidomide and a proteasome inhibitor.
Speaking at the 62nd ASH Annual Meeting, Professor Meletios Dimopoulos presented the findings of the phase 3 APOLLO study comparing D-Pd versus Pd alone in this patient group.
He said the subcut formulation of daratumumab has similar efficacy and safety profiles as IV daratumumab but had the added benefit of significantly lower rates of infusion-related reactions and a shorter administration duration of five minutes.
Professor Dimopoulos, from the National and Kapodistrian University of Athens, said subcut dartumumab had recently been approved in North America, South America, Europe and Asia.
The study comprised 300 patients with RRMM from 12 European countries. Patients were mainly an elderly population (median age 68 yrs), about one-third had advanced stage disease at time of treatment and one-third had high risk cytogenetics.
Patients had received a median of two previous lines of therapy and entered into the study about 4.5 yrs after their myeloma diagnosis.
The study found a statistically significant and clinically meaningful difference in PFS in favour of D-PD over Pd alone. Overall, the median PFS was 12.4 months versus 6.9 months (HR 0.63, p=0.0018). The 12-month PFS rate was 52% versus 35%.
“Thus, the addition of subcut daratumumab to Pd improved PFS with a 37% reduction in the risk of progression or death.”
“This benefit was essentially seen across all subgroups of patients including younger and older patients, patients with different ISS disease staging, regardless of lines of prior therapy, regardless of cytogenetic risk and also in patients who were refractory to lenalidomide.”