Real-world data on the efficacy and safety of daratumumab treatment in Hungarian relapsed/refractory multiple myeloma patients

Abstract

Daratumumab is a human anti-CD38 monoclonal antibody used in the treatment of refractory and relapsed multiple myeloma. We investigated the efficacy and safety of daratumumab therapy in a real-world setting. Ninety-nine Hungarian patients were included; 48 received monotherapy, while lenalidomide and bortezomib combinations were administered in 29 and 19 cases, respectively. Overall response rate was assessable in 88 patients, with 12 complete, 10 very good partial, 34 partial, and seven minor responses. At a median duration of follow-up of 18.6 months, median progression-free survival (PFS) among all patients was 17.0 months. These values were inferior in the bortezomib combination and monotherapy groups. Patients with early-stage disease (ISS1) had better survival results than those with stage 2 or 3 myeloma (p = 0.009). Heavily pretreated patients had inferior PFS compared to those with 1-3 therapies (p = 0.035). Patients with impaired renal function had PFS results comparable with those having no kidney involvement. There were 10 fatal infections, and the most frequent adverse events were mild infusion-associated reactions and hematologic toxicities. Our results confirm that daratumumab is an effective treatment option for relapsed/refractory MM with an acceptable safety profile in patients with normal and impaired renal function.

Early Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated Patients With Relapsed/Refractory Myeloma

“…3 A pooled analysis of these monotherapy studies showed an overall response rate (ORR) of 31.1%, median progression-free survival (PFS) of 4.0 months, median overall survival (OS) of 20.1 months, and a manageable toxicity profile for patients treated with daratumumab at 16 mg/kg. 10 The efficacy and favorable tolerability of daratumumab monotherapy has been consistently reported from recent real-world studies performed in countries such as the United States, Korea, Poland, Spain, Italy, Russia, the United Kingdom, Hungary, and Japan, with the ORR ranging from 23% to 56.3% [11][12][13][14][15][16][17] ( Table 1).…”

“…Salomon-Perzy nski et al 13 Cejalvo et al 14 Cook et al 15 Lovas et al 16 Iida et al 17 Present Study (Turkish Cohort)…”

“…Hence, our findings indicate that daratumumab monotherapy is an effective and tolerable treatment option for RRMM in Turkish patients, similar to that consistently reported in recent real-world studies from other countries. [11][12][13][14][15][16][17] The findings from the US cohort of a multicenter, open-label, daratumumab EAP study of patients with RRMM and ! 3 previous therapy lines revealed an ORR of 23% (PR in 18%, VGPR in 5%, stringent CR in 0.6%).…”

“…15 In another real-world retrospective analysis of 99 patients with RRMM with a median of 3 previous therapy lines from Hungarian centers, the ORR was assessable for 88 patients (CR, 13.6%; VGPR, 11.4%; PR, 38.6%). 16 In the Hungarian cohort, 48 of 99 patients had received monotherapy with dexamethasone only; for the others, either bortezomib or lenalidomide was combined. 16 The investigators reported a median PFS of 17.0 months after a median follow-up of 18.6 months.…”

Monoclonal antibodies in relapsed/refractory myeloma: updated evidence from clinical trials, real-life studies, and meta-analyses

“…Lovas et al investigated daratumumab therapy in 99 patients with RRMM in a real-world setting (48 as a single agent, 29 and 19 cases in combination with lenalidomide and bortezomib, respectively) [46]. Among 88 evaluable patients, 12 achieved CR, 10 VGPR, and 34 PR.…”