A new study suggests the monoclonal antibody daratumumab has similar benefits when delivered via subcutaneous injection as it does when delivered intravenously to patients which myeloma persists or recurs after first-line treatments. Patients given subcutaneous daratumumab along with the immunomodulator pomalidomide and the anti-inflammatory steroid dexamethasone were 37% less likely to die or have their disease worsen compared to patients who received pomalidomide and dexamethasone alone in the phase III trial.
“This is an effective combination with a predictable safety profile that allows for the use of subcutaneous daratumumab along with oral pomalidomide and dexamethasone for patients who have received at least one prior line of therapy that included lenalidomide and a proteasome inhibitor,” said Dr Meletios A. Dimopoulos, MD, of National and Kapodistrian University of Athens in Athens, Greece and lead author of this research. “Subcutaneous daratumumab is much easier for the patient and reduces the time they need to spend at the outpatient chemotherapy unit.”
Delivering daratumumab intravenously typically requires patients to spend a full day at the clinic for each infusion. Administering the therapy via a five-minute subcutaneous injection can substantially reduce the burden for patients and clinics, Dr Dimopoulos said. Also, the subcutaneous formulation of this drug has a similar safety profile as the intravenous formulation, with a statistically significant reduction in infusion-related reaction (IRR) rates, “which is an improvement of patients’ quality of life”, said Dr Dimopoulos.
“Subcutaneous daratumumab is much easier for the patient and reduces the time they need to spend at the outpatient chemotherapy unit.”Dr Meletios A. Dimopoulos, MD, of National and Kapodistrian University of Athens in Athens, Greece
The researchers enrolled 304 patients in 12 European countries. Half were randomly assigned to receive daratumumab plus pomalidomide with dexamethasone and half only received pomalidomide with dexamethasone. Patients underwent 28-day treatment cycles until their disease worsened or they experienced unacceptable side effects.
About one-third of patients died during the trial’s median follow-up period of about 17 months. The study met its primary endpoint, showing a significantly higher rate of progression-free survival at 12 months among patients receiving the combination therapy. Participants receiving the daratumumab-pomalidomide combination were treated for a median of nearly 12 months, substantially longer than the median treatment duration of less than seven months among those receiving pomalidomide alone.
Patients receiving daratumumab experienced adverse events at a rate consistent with previous studies, raising no new safety concerns. Dr Dimopoulos said the findings suggest the combination therapy can be a good option for patients who have not experienced lasting benefits from lenalidomide and proteasome inhibitors, particularly those whose cancer is resistant to lenalidomide. He noted that the study suggested a slight trend toward increased survival in the daratumumab arm, but additional follow-up is necessary to assess any survival benefit.