Subcutaneous Versus Intravenous Daratumumab in Resistant Multiple Myeloma
Posted: Tuesday, July 30, 2019
According to results from the phase III COLUMBA trial, presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract 8005), subcutaneous daratumumab demonstrated noninferiority to intravenous daratumumab in treating patients with relapsed or refractory multiple myeloma. Subcutaneous daratumumab significantly reduced infusion-related reaction rates and administration time for patients, while also exhibiting a comparable safety profile, concluded Maria-Victoria Mateos, PhD, of the University Hospital of Salamanca, Spain, and colleagues.
“Daratumumab IV has proven to be an important medication in the treatment of multiple myeloma, and a new subcutaneous formulation may offer patients a different experience, including a shorter administration time,” Dr. Mateos said in a press release.
The authors enrolled 522 patients diagnosed with relapsed or refractory multiple melanoma to participate in the open-label, multicenter clinical trial (ClinicalTrials.gov identifier NCT03277105). All patients received at least three prior lines of treatment and then were administered either 1,800 mg of daratumumab and 2,000 U/mL of recombinant human hyaluronidase by subcutaneous delivery (263 patients) or 16 mg/kg of daratumumab intravenously (259 patients).
Patients treated subcutaneously exhibited an overall response rate of 41% compared with 37% for the patients who received treatment through intravenous delivery. Those treated subcutaneously also retained at least 89% of the benefit of daratumumab administered intravenously. The authors observed a significantly lower rate of infusion-related reactions with subcutaneous treatment (12.7%) versus intravenous treatment (34.5%).
The median duration of injections for subcutaneous application was significantly shorter at 5 minutes, compared with 421 minutes, 255 minutes, and 205 minutes for first, second, and subsequent daratumumab infusions, respectively. Median progression-free survival among patients who received subcutaneous therapy was 5.6 months versus 6.1 months in those who received intravenous therapy. The most common treatment-emergent adverse events were anemia, neutropenia, thrombocytopenia, and diarrhea.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.