Results of a recent systematic literature review and meta-analysis have shown that the inclusion of daratumumab in multiple myeloma (MM) regimens may be linked to better progression-free survival (PFS). The results of this analysis were reported in JAMA Oncology.

According to the researchers, daratumumab has shown mixed results in terms of improvements in PFS in some prior analyses. Thus the researchers undertook a systematic review of trials evaluating the addition of daratumumab to treatments for MM to examine any effects on PFS in a meta-analysis.

The research team searched for phase 3 clinical trials related to MM and daratumumab, primarily from multiple online repositories. Eligible studies were required to emphasize comparisons of MM treatments with or without daratumumab. Newly diagnosed and relapsed/refractory settings were both examined. In addition to comparisons of daratumumab vs a control, included studies had to show outcomes according to cytogenetic risk status.

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PFS, among patients with high-risk MM (HRMM), was the primary outcome of interest in this analysis. HRMM was characterized by t(4;14), t(14;16), or del(17p) status.

Of the 5194 studies found, 6 trials were considered eligible for analysis; 3 of the trials focused on newly diagnosed patients (2528 patients) and the other 3 trials focused on the relapsed/refractory setting (1533 patients). HRMM was found in 358 of the newly diagnosed patients and in 222 of the relapsed/refractory patients.

For patients with newly diagnosed HRMM, PFS appeared to be superior with the inclusion of daratumumab in a treatment regimen (pooled hazard ratio [HR], 0.67; 95% CI, 0.47-0.95; P =.02). For patients with relapsed/refractory HRMM, inclusion of daratumumab again was associated with improved PFS (pooled HR, 0.45; 95% CI, 0.30-0.67; P <.001).

The researchers also examined results for patients with standard-risk MM (SRMM). In patients with newly diagnosed SRMM, inclusion of daratumumab was linked to better PFS (pooled HR, 0.45; 95% CI, 0.37-0.54; P <.001). This was also true for relapsed/refractory SRMM (pooled HR, 0.38; 95% CI, 0.26-0.56; P <.001). However, studies in relapsed/refractory SRMM showed evidence of heterogeneity.

“The present study suggests that daratumumab-based regimens are associated with improved PFS among patients with HRMM and SRMM in the context of newly diagnosed and relapsed or refractory disease,” the researchers concluded in their report. They also noted that this benefit appeared with daratumumab added to a variety of MM regimens.

Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.


Giri S, Grimshaw A, Bal S, et al. Evaluation of daratumumab for the treatment of multiple myeloma in patients with high-risk cytogenetic factors: a systematic review and meta-analysis. JAMA Oncol. Published online September 24, 2020. doi:10.1001/jamaoncol.2020.4338