Treatment patterns and effectiveness of patients with multiple myeloma initiating Daratumumab across different lines of therapy: a real-world chart review study

Abstract

Background Daratumumab, a CD38 monoclonal antibody, has demonstrated efficacy as monotherapy and combination therapy across several indications, both among newly-diagnosed and refractory patients with multiple myeloma (MM). However, there is limited evidence on treatment patterns and effectiveness of daratumumab in the real-world setting, particularly in first line (1 L). This study aimed to describe real-world treatment patterns and clinical outcomes among patients initiating daratumumab across different lines of therapy. Methods A retrospective chart review of adult patients with MM initiating daratumumab between November 2015 and March 2021 was conducted at two clinical sites in the United States. De-identified patient-level data were abstracted in an electronic case report form. Patient characteristics and treatment patterns were described. Clinical outcomes including overall response rate (ORR), progression-free survival, and time to next line of therapy were reported using descriptive statistics and stratified by line of therapy (1 L, second line [2 L] or third line or later [3 L+]). A sub-group analysis evaluated treatment patterns and ORR among patients re-treated with daratumumab. Results A total of 299 patients were included in the study (mean age: 68 years; 55% male). Among them, 26 were 1 L patients, 66 were 2 L patients, and 207 were 3 L+ patients; 110 patients (36.8%) received a stem cell transplant prior to daratumumab initiation. The mean duration of follow-up was 10 months among 1 L patients and 19 months among 2 L and 3 L+ patients. Patients who initiated daratumumab in 1 L had a 100% ORR, while those initiating in 2 L and 3 L+ had an ORR of 78.8 and 65.2%, respectively. Among re-treated patients, ORR was 66.7% during the first treatment segment, and 52.9% during the second treatment segment. Kaplan-Meier rates of progression-free survival at 12 months were 89.9, 75.2, and 53.1% among patients who initiated daratumumab in 1 L, 2 L, and 3 L+, respectively. Kaplan-Meier rates of time to next line of therapy at 12 months were 94.1, 73.4, and 50.0% among patients who initiated daratumumab in 1 L, 2 L, and 3 L+, respectively. Conclusions These findings suggest that daratumumab-based regimens are an effective treatment option across all lines of therapy, with highest response rate in 1 L.

Outcomes of daratumumab in the treatment of multiple myeloma: A retrospective cohort study from the Canadian Myeloma Research Group Database

“…While clinical trials demonstrate impressive benefit of darabased therapies, possible discordance with real-world practice might exist, as many patients in the real world are known to be ineligible for clinical trials. 22,23 A few small real-world multicentre studies specifically focusing on dara have been published, confirming the promising activity noted in clinical trials [23][24][25][26][27] [28][29][30][31] There remains a paucity of studies evaluating the outcomes of dara-containing regimens in larger realworld cohorts. Our study aimed to evaluate the impact of these regimens and to benchmark outcomes that may identify gaps that can be targeted for future optimization.…”

“…While clinical trials demonstrate impressive benefit of dara‐based therapies, possible discordance with real‐world practice might exist, as many patients in the real world are known to be ineligible for clinical trials 22,23 . A few small real‐world multicentre studies specifically focusing on dara have been published, confirming the promising activity noted in clinical trials 23‐27 (Atrash et al, 2021; Harvanová et al, 2021; Maouche et al, 2021; Szabo et al, 2021) 28‐31 . There remains a paucity of studies evaluating the outcomes of dara‐containing regimens in larger real‐world cohorts.…”

Multiple Myeloma in the Era of Novel Agents and Stem Cell Therapies

“…Daratumumab has demonstrated efficacy as monotherapy and combination therapy across several indications, both among newly diagnosed and refractory patients with MM. Daratumumab-based regimens are an effective treatment option across all lines of therapy, with highest response rate in first-line [55]. Daratumumab triplet regimen (DRd) has been shown to be superior to other triplet regimens for the treatment of RR-MM, and daratumumab monotherapy has been shown to be more effective than either single agent in heavily pretreated MM patients, suggesting that daratumumab is effective in the treatment of RR-MM [56].…”

Correction to: Treatment patterns and effectiveness of patients with multiple myeloma initiating Daratumumab across different lines of therapy: a real-world chart review study

“…Author details 1 Levine Cancer Institute, Charlotte, NC, USA. 2 Analysis Group, Inc, 1190 avenue des Canadiens-de-Montréal, Deloitte Tower, Suite 1500, Montreal, QC H3B 0G7, Canada.…”

“…Correction to: BMC Cancer 21, 1207 (2021) https://doi.org/10.1186/s12885-021-08881-7 Following publication of the original article [1], it was identified that due to typesetting mistakes, an unfinalized version of the article were published. The following changes have been implemented.…”