Rapid steroid tapering appears safe in myeloma treated with daratumumab
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Rapid corticosteroid tapering over 2 weeks was safe in patients with relapsed or refractory multiple myeloma who received subcutaneous daratumumab, according to findings presented at ASCO20 Virtual Scientific Program.
Hareth Nahi, MD, PhD, of Karolinska University Hospital at Huddinge, Stockholm, Sweden, and colleagues reported initial results from part 3 of PAVO, an open label, non-randomized, multicenter phase 1b study examining the safety of pre- and post-dose corticosteroid tapering during subcutaneous daratumumab (Darzalex, Jannsen) administration.
“While corticosteroid premedication may be continued, corticosteroid tapering with subcutaneous daratumumab may be equally tolerated without loss of efficacy,” Nahi said during his presentation.
Patients with relapsed or refractory multiple myeloma with at least two prior lines of treatment received subcutaneous daratumumab by subcutaneous injection per the approved IV monotherapy dosing schedule, according to the abstract. They received a 3-week tapering schedule, in which patients were steroid-free by cycle one day 22 or a 2-week tapering schedule, in which patients were steroid-free by cycle one day 15. All patients also received methylprednisolone orally/IV pre-dose and orally post-dose.
Fifteen patients comprised the 3-week group and 15 comprised the 2-week group (37% refractory to a proteasome inhibitor and an immunomodulatory
drug) The 3-week group received a median of 14 and the 2-week group received a median of 8 subcutaneous daratumumab doses without corticosteroids.
No IRRs occurred in the 3-week group, but three patients in the 2-week group reported IRRs on cycle one day 1 (grade 3 hypertension; grade 2 chills; and grade 1 pyrexia, oropharyngeal pain, and tachycardia), according to the presentation. IRRs occurred within 2 hours of the first administration and no IRRs occurred at later administrations.
Nahi and colleagues reported that the most common treatment-emergent adverse events included upper respiratory tract infection (40%), fatigue (27%) and nausea (27%), and the most common grade 3/4 treatment-emergent adverse events included anemia, lymphopenia, neutropenia, and hypertension (7% for each).
At the median follow-up of 6.8 months for the 3-week group and 2.4 months for the 2-week group, the ORRs were 40% (95% CI, 16-68%) and 27% (95% CI, 8-55%), with very good partial response rates of 13% (95% CI, 2-40%) and 7% (95% CI, 0-32%), according to the data.
“This study in 30 patients showed that tapering of pre- and post-dose corticosteroids over 3 or 2 weeks was not associated with increased rates of IRRs and demonstrated similar efficacy to patients receiving daratumumab IV,” Nahi said. “These data help guide future subcutaneous daratumumab combinations, including T-cell redirectors, CAR T or checkpoint inhibitors where limiting concurrent corticosteroids may be preferred.”
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Nahi H, et al. Abstract 8537. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.
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