Results from the COLUMBA study that were presented at the 2019 ASH Annual Meeting showed a favorable benefit/risk profile for subcutaneous (SC) daratumumab for the treatment of multiple myeloma (MM). This SC administration was also associated with less infusion-related reactions (IRRs), reduced costs, and patient satisfaction.
The randomized, open-label, non-inferiority, phase III study compared intravenous (IV) versus SC administration of daratumumab among patients with relapsed/refractory MM. The study included adults who had received three or more prior lines of therapy, including a proteasome inhibitor and immunomodulatory drug.
In the intention-to-treat population, 522 patients (median age, 67 years; median baseline body weight, 73 kg) received SC daratumumab 1,800 mg with recombinant human hyaluronidase PH20 (n=263) or IV daratumumab 16 mg/kg (n=259) in 28-day cycles. SC daratumumab was administered by a manual push over three to five minutes alternating between left and right abdominal sites.
Patients received a median of four prior therapies, and 82.2% were refractory to their last line of prior therapy. After a median follow-up of 13.8 months, the overall response rate (ORR; co-primary endpoint) improved from 41.1% to 43.7% with SC daratumumab and from 37.1% to 39.4% with IV daratumumab. ORR was comparable across all subgroups. Rates of deep responses were similar between the two administration cohorts. At data cutoff, 118 patients, evenly distributed between arms, were still receiving treatment.
“With longer follow-up, safety and efficacy data continue to support that SC daratumumab and IV daratumumab have similar safety profiles with a statistically significant reduction in IRR rates,” the authors concluded. “SC daratumumab has a reduced treatment burden due to a considerably shorter administration duration, and [patients receiving] SC daratumumab reported higher treatment satisfaction.”
Usmani SZ, Mateos MV, Nahi H, et al. Randomized, open-label, non-inferiority, phase 3 study of subcutaneous (SC) versus intravenous (IV) daratumumab (DARA) administration in patients with relapsed or refractory multiple myeloma: Columba update. Abstract 1865. Presented at the 2019 ASH Annual Meeting, December 7, 2019; Orlando, Florida.