Role of Daratumumab in Relapsed and Refractory Multiple Myeloma Patients: Meta-Analysis and Literature Review

Abstract

IntroductionIn 2015, U.S. Food and Drug Administration granted daratumumab approval, based on two phase II studies, as monotherapy (16 mg/kg in heavily treated patients) for MM patients who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or patient's double refractory to these agents [1]. Daratumumab is a human IgG1 monoclonal antibody targeting CD38, expressed at high levels on malignant cells in multiple myeloma (MM) [2]. METHODS AND METHODOLOGYThis meta-analysis was conducted according to Cochrane Collaboration guidelines and reported as per PRISMA guidelines and its summary is given in Figure 1. Two authors (AA and MZ) performed a systematic literature search using databases such as MEDLINE (via PubMed), Embase, and Cochrane library using the medical search terms: “daratumumab, refractory, relapsed, multiple myeloma”. Three of the totals of 679 articles reviewed were selected as having identical primary and secondary outcomes ResultsA total of 3 studies including 1533 patients (849 in Daratumumab treatment group while 684 patients in control group) were included in the study (Figure I). Mean age was 65 years in both groups. 54.4% had a progression free survival in daratumumab group as compared to 8% in control. Overall response rate, very good partial response, and complete response favors treatment group while minimal and partial response outcome favored control group. Adverse effects were more common in treatment group as compared to treatment group. DiscussionIn ELOQUENT-3 trial, role of Elotuzumab was studied in RRMM patients which showed ORR of 53% in treatment group in comparison to our study which showed ORR of 85.2% with significant p-value of <0.001 [3]. Similar kind of results were seen with Eloquent-2 trial which showed overall response rate of 79 % respectively [4].