Daratumumab appears safe for patients with multiple myeloma, advanced renal insufficiency
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CHICAGO — Daratumumab appeared safe for patients with multiple myeloma who had advanced renal insufficiency, according to study results presented at ASCO Annual Meeting.
“The take-home message from our study is that there was no significant impact of the treatment on renal function at 12 months,” researcher Mateusz Niewinski, BA, BPS, PharmD, pharmacy resident at NYU Langone Health, told Healio. “Compared [with] published data on patients treated with creatinine clearance greater than 30 mL/min, there does not appear to be a detriment to survival or an increase in adverse events when using daratumumab regimens [for] patients with more advanced renal insufficiency.”
Daratumumab (Darzalex, Janssen), a CD38-directed monoclonal antibody, is approved in the United States for treatment of several specific patient populations with multiple myeloma.
Daratumumab-based regimens that target CD38 can extend remission among patients with newly diagnosed or relapsed disease.
“Daratumumab trials excluded [patients with multiple myeloma] with creatinine clearances of less than 30 mL/min, making the use of the agent limited in this patient population,” Niewinski said.
Niewinski and colleagues aimed to assess real-world use of daratumumab for patients with multiple myeloma and renal insufficiency.
They performed a retrospective chart review of 101 patients (median age, 74 years; range, 54-92; 45.5% women) at their institution with relapsed multiple myeloma who had reduced creatinine clearance and received at least one dose of between October 2018 and January 2022. Fourteen percent of patients were on hemodialysis.
Patients had received a median two lines of prior therapy, the majority had stage II (35%) or stage III (45%) disease per Revised Multiple Myeloma International Staging System criteria, and 20% had high-risk cytogenetics.
All patients received IV daratumumab, and about half (52%) subsequently received the subcutaneous formulation, daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen).
Study outcomes included creatinine clearance changes during treatment, adverse events and survival.
Patients received a median 23 daratumumab infusions (range, 1-60) over a median 18 months (IV, median = 16; subcutaneous, median = 10).
Regimens included daratumumab with lenalidomide (Revlimid, Bristol Myers Squibb and dexamethasone? [32%]); daratumumab with pomalidomide (Pomalyst, Bristol Myers Squibb) and dexamethasone (35%); daratumumab with carfilzomib (Kyprolis; Amgen and dexamethasone? [13%]); or daratumumab with bortezomib (Velcade; Takeda) and dexamethasone (35%).
Researchers reported median creatinine clearance of 45 mL/min (range, 7.3-101) at multiple myeloma diagnosis and 40 mL/min (range, 5.3-107) at initiation of daratumumab treatment. One-third (33%) had creatinine clearance less than 30 mL/min.
Researchers reported median creatinine clearance levels of 45 mL/min after 3 months of treatment with a daratumumab-based regimen (n = 95), 43 mL/min after 6 months (n = 89) and 41 mL/min after 12 months (n = 69).
Results showed no differences in renal function among patients who subsequently received subcutaneous daratumumab.
At data cutoff, 16 patients (15.8%) had died and 23% had received subsequent treatment.
Investigators reported a 5-year PFS rate of 54% and median OS of 63 months.
The PFS analysis showed patients with poorer renal function were able to survive 14 months longer than those with creatinine clearance greater than 30 mL/min while on daratumumab, Niewinski said.
“[This finding] was surprising and may need a larger population studied to become statistically significant,” he added.
The most common adverse events included anemia (37%) and neutropenia (15%). About one in five patients (19%) developed infusion-related reactions.
“Being that this was a retrospective chart review with 101 patients, there is definitely room to study this in even larger populations and get more statistically significant results,” Niewinski told Healio. “However, the results we found are able to guide daratumumab use in renally impaired patients or hemodialysis patients going forward.”
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Niewinski M, et al. Abstract 8026. Presented at: ASCO Annual Meeting; June 3-7, 2022; Chicago.
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