OBJECTIVES:

To characterize real-world outcomes of daratumumab in patients with relapsed/refractory multiple myeloma (RRMM).

METHODS:

A systematic literature review was conducted of publications from January 2015 to May 2020 in Embase, PubMed, and American Society of Hematology and European Hematology Association conference abstracts. Eligibility criteria included daratumumab-approved regimens in MM, ≥20 patients, and written in English. Publications reporting efficacy, safety, patient-reported outcomes (PROs), quality of life (QoL), or cost-effectiveness were considered.

RESULTS:

Overall, 43 publications were identified that reported real-world studies with daratumumab in MM, 42 in the RRMM setting (n=4,538) and 1 in front-line that evaluated daratumumab+bortezomib+melphalan+prednisone. Of the publications on RRMM, 16 reported data on daratumumab monotherapy, 7 on daratumumab+lenalidomide+dexamethasone (D-Rd), 7 on daratumumab+bortezomib+dexamethasone (D-Vd), 4 on daratumumab+pomalidomide+dexamethasone (D-Pd), and 14 as part of a pooled therapy (some publications reported >1 daratumumab regimen). In total, 37 publications reported efficacy, 20 reported safety, 3 reported cost-effectiveness data, and none reported PROs or QoL. Patient populations included those with high clinical unmet need such as those who were lenalidomide-refractory (n=650) or immunomodulatory drug-refractory (n=612), had previous stem cell transplantation (n=732), high-risk cytogenetics (n=86), or Eastern Cooperative Oncology Group performance status 2 (n=120) or 3 (n=18). Despite shorter follow-up, survival results and safety profile were generally consistent with data from randomized controlled trials. Best median progression-free survival was 9.5 months (95% confidence interval [CI], 6.4─12.5; median follow-up 11.7 months, n=107) with daratumumab monotherapy, 26.6 months (95% CI, 20.7─62.8; median follow-up 11.8 months, n=263) with D-Rd, 11.5 months (95% CI, 2.76─not evaluable; follow-up not reported, n=23) with D-Vd, and 25.0 months (95% CI, 5.0─not evaluable; median follow-up 29.0 months, n=86) with D-Pd.

CONCLUSIONS:

These findings confirm and provide certainty that in a real-world setting, daratumumab is effective across different patient populations with RRMM regardless of patient disease characteristics or clinical features.