Summary

• Janssen does not recommend any practices, procedures or practice guidelines that deviate from the product labeling or are not approved by the regulatory agencies.
• Roque et al (2019)¹ conducted a retrospective analysis to evaluate the effect of being overweight (body mass index [BMI] ≥25 kg/m²) on outcomes and adverse events (AEs) in patients with multiple myeloma (MM) who received DARZALEX (N=23; 9 patients were overweight).
  • No significant difference in overall survival (OS) was observed between patients who were not overweight and those who were overweight (16.1 months vs not reached [NR]; P=0.061).
  • There were no significant differences in AEs between patients who were not overweight and those who were overweight; however, detailed safety results for the overweight group were not reported.
• Based on population PK analysis body weight was identified as a statistically significant covariate for daratumumab clearance. Therefore, body weight based dosing is an appropriate dosing strategy for the multiple myeloma patients.²

PRODUCT LABELING

• DARZALEX (daratumumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf

CLINICAL data

Retrospective Study

Roque et al (2019)¹ conducted a retrospective analysis to evaluate the effect of being overweight on outcomes and AEs in patients with MM who received DARZALEX.

Study Design/Methods

• The analysis reviewed data from 23 patients with MM who received DARZALEX from 2017 to 2018; 9 of the 23 (39.1%) patients were overweight (BMI ≥25 kg/m²).
• DARZALEX was administered at a dose of 16 mg/kg.
• Disease characteristics of the patients, AEs, and outcomes were assessed and were correlated with biometric data.

Results

Patient Characteristics

• The median age was 61 years (range, 36-76) and 52% were male.
• Eight (34.8%) patients had stage 3 disease according to the International Staging System.
• Median number of prior lines of therapy was 2 (range, 1-5; 47.8% had received ≥4 lines previously).
• At the time of diagnosis, 87.0% of patients had bone disease and 13.0% of patients had extramedullary disease.
• DARZALEX was used in combination with lenalidomide/dexamethasone in 73.9% of patients, in combination with pomalidomide/dexamethasone in 13.0% of patients, and as a monotherapy in 13.0% of patients.

Efficacy

• No significant difference in OS was observed between patients who were not overweight and those who were overweight (16.1 months vs NR; P=0.061); overall, the median OS was 16.1 months.
• No significant differences were observed between patients who were not overweight and those who were overweight in clinical characteristics at the time of diagnosis and during DARZALEX initiation, previous treatments, and response to DARZALEX.
• After 4 and 12 DARZALEX infusions, partial response or higher was observed in 73.3% and 82.4% of patients, respectively.
• At the time of last follow-up, 9 (39.1%) patients discontinued DARZALEX (3 patients discontinued due to progressive disease, 3 patients discontinued for autologous hematopoietic stem cell transplantation, and 3 patients died [2 patients with progressive disease]).

Safety

• There were no significant differences in AEs between patients who were not overweight and those who were overweight; however, detailed safety results for the overweight group were not reported.
• Overall, at first DARZALEX infusion, grade ≥2 AEs were reported in 9 (39.1%) patients.
• During DARZALEX treatment, at least one grade ≥2 cytopenia was reported in 87.0% of patients (neutropenia in 9 patients, thrombocytopenia in 5 patients, and grade ≥3 anemia in 2 patients).
• Infection (mostly respiratory) was reported in 10 (43.5%) patients and venous thromboembolism (considered probably related to lenalidomide) was reported in 3 patients.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on
18 March 2024.