SUMMARY

• COLUMBA (MMY3012) is an ongoing phase 3, randomized, open-label, multicenter, non-inferiority study evaluating the efficacy, pharmacokinetics (PK) and infusion-related reactions (IRRs) of intravenous (IV) DARZALEX vs DARZALEX FASPRO in patients with relapsed or refractory multiple myeloma (RRMM).^1,2
  • Usmani et al (2022)² reported final analysis of efficacy and safety results of the COLUMBA study after a median follow-up of 29.3 months. With the longer follow-up, the overall response rate (ORR) was 43.7% in the DARZALEX FASPRO arm and 39.8% in the DARZALEX arm. Median PFS was 5.6 months vs 6.1 months and median overall survival (OS) was 28.2 months vs 25.6 months in the DARZALEX FASPRO vs DARZALEX arms, respectively. The most common grade 3/4 (≥10%) treatment-emergent adverse events (TEAEs) were thrombocytopenia (DARZALEX FASPRO, 14.2%; DARZALEX, 13.6%), anemia (DARZALEX FASPRO, 13.8%; DARZALEX, 15.1%), and neutropenia (DARZALEX FASPRO, 13.1%; DARZALEX, 7.8%).
  • Luo et al (2019)³ evaluated population pharmacokinetic (PPK) and exposure-response (E-R) analysis to compare DARZALEX FASPRO vs DARZALEX in patients with RRMM from the following phase 2 and 3 studies: PAVO (NCT02519452)⁵, MMY1008⁶ (NCT03242889) and COLUMBA (NCT03277105).
  • Usmani et al (2021)⁴ reported results on the satisfaction of patients with therapy data collected via a patient-reported outcome instrument in the COLUMBA study. Overall, results indicated that DARZALEX FASPRO patients were more satisfied with their cancer therapy and had more positive perceptions of their treatment than DARZALEX patients.
  • Iida et al (2021)⁷ conducted an exploratory subgroup analysis in Asian patients from the COLUMBA study. Of the 67 Asian patients, 42 Japanese patients were included in the analysis and separate results have been reported. Results from this subgroup analysis were mostly relatable with the overall COLUMBA study in terms of efficacy, PK, safety, and patient satisfaction. Neutropenia was the most common hematologic treatment emergent adverse event (TEAE) reported in both the Asian subgroup and Japanese patients-only subgroup analyses. Patients in this analysis reported a higher incidence of grade 3/4 neutropenia (26.7% in DARZALEX FASPRO; 13.5% in DARZALEX arm) than reported in the overall COLUMBA study.⁷ See tables: Most Common Grade 3/4 (>5%) TEAEs Across Body Weight Subgroups in Asian Patients and Overall Responses and Duration of Response in Asian Subgroup Analysis for details of safety and efficacy results.

PRODUCT LABELING

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

CLINICAL DATA

Phase 3 Study

COLUMBA (MMY3012; clinicaltrials.gov identifier: NCT03277105) is an ongoing phase 3, randomized, open-label, multicenter, non-inferiority study evaluating the efficacy, PK and IRRs of DARZALEX vs DARZALEX FASPRO in patients with RRMM.^1,8 Mateos et al (2020)¹ reported primary analysis of efficacy and safety results of the COLUMBA study after a median follow-up of 7.5 months. Usmani et al (2019)⁸ reported updated analysis of efficacy and safety results of this study after a median follow-up of 13.7 months. Usmani et al (2022)² reported final analysis of efficacy and safety results of the COLUMBA study after a median follow-up of 29.3 months.

Study Design/Methods

• Phase 3, randomized, open-label, multicenter, non-inferiority study
• The trial enrolled 522 patients from 19 countries, including the United States.
• Patients were randomized to receive either DARZALEX (n=259) or DARZALEX FASPRO (n=263) over 4-week treatment cycles:
  • DARZALEX: daratumumab 16 mg/kg IV infusion weekly for cycles 1 and 2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter, or
  • DARZALEX FASPRO: daratumumab 1800 mg (flat dose) in combination with recombinant human hyaluronidase PH20 (rHuPH20) 2000 Units/mL administered by manual push (15 mL) over 3-5 minutes at alternating left/right abdominal sites, weekly for cycles 1 and 2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter.
• Treatment will continue until disease progression or unacceptable toxicity.
• Pre-infusion medications to be administered are acetaminophen 650-1000 mg, diphenhydramine 25-50 mg, methylprednisolone 60-100 mg, and montelukast 10 mg (optional).
• Post-infusion medications to be administered are methylprednisolone 20 mg, and diphenhydramine, short-acting β2 adrenergic receptor agonist, and control medications for lung disease recommended for patients with higher risk of respiratory complications.
• Key inclusion criteria:
  • Documented multiple myeloma (MM), as defined by the following:
    • MM diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria.
    • Measurable disease at screening, as defined by the following:
      • Serum M-protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours, or
      • Light chain MM without measurable disease in the serum or the urine: serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Evidence of response (partial response or better based on investigator’s determination of response by IMWG) to ≥1 prior treatment regimen.
  • Relapsed or refractory disease
    • Relapsed disease: initial response to previous treatment, followed by confirmed progressive disease by IMWG criteria >60 days after cessation of treatment.
    • Refractory disease: <25% reduction in M-protein or confirmed progressive disease by IMWG criteria during previous treatment or ≤60 days after cessation of treatment
  • Treatment history that includes the following:
    • ≥3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug in any order during the course of treatment, or
    • Shown to be refractory to both a PI and an immunomodulatory drug
  • Eastern Cooperative Oncology Group performance status of ≤2
• Key exclusion criteria:
  • Prior treatment with daratumumab or other anti-CD38 therapies
  • Known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second <50% of predicted normal
  • Known moderate or severe persistent asthma, or history of asthma within the last 2 years, or current uncontrolled asthma of any classification
  • Clinically significant cardiac disease
• Co-primary endpoints: ORR and maximum C_trough (serum pre-dose daratumumab concentration on cycle 3 day 1)
• Secondary endpoints: IRR rates, progression-free survival (PFS), rate of very good partial response or better (≥VGPR) and complete response or better (≥CR), time to next therapy, OS, patient-reported satisfaction with therapy, duration of and time to response

Results

Patient Characteristics

• A total of 522 patients were assigned to either DARZALEX (n=259) or DARZALEX FASPRO (n=263) arm. Baseline demographic and clinical characteristics are summarized in Table: Baseline Demographic and Clinical Characteristics (Intention to Treat).

• Median duration of follow-up was 29.3 months (additional 21.8 months after the primary analysis).

Treatment Exposure and Patient Disposition

• In patients who received ≥1 treatment dose, 90% in the DARZALEX FASPRO and 91.1% in the DARZALEX arm discontinued study treatment. Progressive disease (DARZALEX FASPRO, 75.4%; DARZALEX, 75.6%) was the most common reason for treatment discontinuation as present in Table: Treatment Exposure and Patient Disposition.
• At the clinical cutoff for the final analysis, 26 (10%) vs 23 (8.9%) patients continued treatment in the DARZALEX FASPRO vs DARZALEX arms, respectively.

Efficacy

• ORR and depth of response improved over time (21.8 months after the primary analysis) in both arms as presented in Table: Response Rates in the ITT Population.
  • ORR increased from 41.1% to 43.7% in the DARZALEX FASPRO arm and 37.1% to 39.8% in the DARZALEX arm.
  • ≥VGPR increased from 19% to 23.6% in the DARZALEX FASPRO arm and 17% to 21.6% in the DARZALEX arm (odds ratio [OR], 1.13; 95% confidence interval [CI], 0.74-1.72).
  • ≥CR increase from 1.9% to 4.6% in the DARZALEX FASPRO arm and 2.7% to 5.4% in the DARZALEX arm.
• Median duration of response was 10.2 (range, 9.2-13.8) months in the DARZALEX FASPRO arm and 10.6 (range, 9.2-15.6) months in the DARZALEX arm.
• Median time to ≥CR increased from 4.2 to 9.3 months in the DARZALEX FASPRO arm and 3.8 to 7.2 months in the DARZALEX arm.
• Median time to ≥VGPR was consistent with the primary analysis, 2 (range, 1-19.4) months vs 1.9 (range, 0.9-22.8) months in the DARZALEX FASPRO vs DARZALEX arms.
• Median PFS was consistent with the primary analysis, 5.6 (95% CI, 4.7-7.5) months vs 6.1 (95% CI, 4.7-7.5) months in the DARZALEX FASPRO vs DARZALEX arms, respectively (hazard ratio [HR], 0.98; 95% CI, 0.81-1.19; P=0.8247).
  • The estimated 12-month PFS rate was 27.2% vs 27.6% in the DARZALEX FASPRO vs DARZALEX arms, respectively.
• Median OS was 28.2 (95% CI, 22.8-not evaluable) months vs 25.6 (95% CI, 22.1-not evaluable) months in the DARZALEX FASPRO vs DARZALEX arms, respectively (HR, 0.92; 95% CI, 0.72-1.18; P=0.4962).
  • The estimated 24-month OS rate was 55.8% (95% CI, 49.4-61.7) vs 51.6% (95% CI, 45.1-57.6) in the DARZALEX FASPRO vs DARZALEX arms, respectively.
• Median time to next therapy was 8.8 (95% CI, 7.6-10.9) months vs 9.4 (95% CI, 8.2-10.7) months in the DARZALEX FASPRO vs DARZALEX arms, respectively (HR, 0.99; 95% CI, 0.81-1.21).
• Time from randomization to progression on next line of therapy or death (PFS2) was 19.0 (95% CI, 16.6-21.7) months vs 18.1 (95% CI, 15.1-21.0) months in the DARZALEX FASPRO vs DARZALEX arms, respectively (HR, 0.87; 95% CI, 0.70-1.10; P=0.2449).
  • The estimated 24-month PFS2 rate was 42.1% (95% CI, 35.8-48.4) vs 37.1% (95% CI, 30.9-43.4) in the DARZALEX FASPRO vs DARZALEX arms, respectively.
• In the DARZALEX FASPRO arm, patients showed similar response rates across all weight subgroups (≤65 Kg, >65-85 kg, and >85 kg) as present in the Table: Efficacy Endpoints by Baseline Body Weight Subgroups.

Pharmacokinetics and Immunogenicity

• The mean maximum C_trough was 581 (standard deviation [SD], 315) μg/mL for the DARZALEX FASPRO arm and 496 (SD, 231) μg/mL for the DARZALEX arm.
• Anti-daratumumab antibodies were detected through initial drug tolerance (DT) method (concentration of daratumumab, 4000 μg/mL) and enhanced DT method (concentration of daratumumab, 630 μg/mL).
  • One (0.4%) patient in the DARZALEX FASPRO arm and 6 (2.6%) patients in the DARZALEX arm tested positive for anti-daratumumab antibodies.
    • In the DARZALEX arm, peak titer was 1:6 in 3 patients, 1:24 in 1 patient, and 1:192 in 1 patient based on the enhanced DT method, and 1:20 in 1 patient based on the initial DT method.
    • In the DARZALEX FASPRO arm, peak titer was 1:192 in 1 patient based on the enhanced DT method.
    • One patient in the DARZALEX FASPRO arm and 5 of 6 patients in DARZALEX arm who tested positive for anti-daratumumab antibodies also tested positive for neutralizing antibodies.
• Fifteen of 224 (6.7%) patients had treatment-emergent anti-rHuPH20 antibodies post DARZALEX FASPRO administration and the peak titer was 1:5 in 10 patients, 1:10 in 3 patients, and 1:80 in 2 patients. No patients tested positive for neutralizing antibodies to rHuPH20.

Safety

• Safety profiles were similar and consistent with the primary analysis. Any grade TEAEs occurred in 91.5% (n=238) vs 93% (n=240) and grade 3/4 occurred in 50.8% (n=132) vs 52.7% (n=136) of patients in the DARZALEX FASPRO vs DARZALEX arms, respectively. See Table: Incidence of TEAEs in the Safety-Evaluable Population, and Most Common Any Grade (≥10%) and Grade 3/4 (≥5%) TEAEs in the Safety-Evaluable Population.
• The overall incidence of serious TEAE was 31.9% vs 34.5% in the DARZALEX FASPRO vs DARZALEX arms.
  • The most common serious adverse event (SAE) was pneumonia (DARZALEX FASPRO, 4.6% [n=12]; DARZALEX, 5% [n=13]).
• Secondary primary malignancies occurred in 3.8% (n=10) vs 3.9% (n=10) in the DARZALEX FASPRO vs DARZALEX arms, respectively.
• Treatment modifications due to any grade TEAEs occurred in 30% (n=78) vs 32.6% (n=84) in the DARZALEX FASPRO vs DARZALEX arms, respectively.
• With the longer follow-up, the rates of any grade and grade 3/4 TEAEs across all body weight subgroups (≤65 Kg, >65-85 kg, and >85 kg) were similar to the overall population. See Table: Most Common Grade 3/4 (≥5%) TEAEs Across Body Weight Subgroups.
  • In ≤65 kg subgroup, incidence of neutropenia was higher in the DARZALEX FASPRO vs DARZALEX arms for any grade TEAEs (25.8% vs 14.1%) and grade 3/4 TEAEs (20.4% vs 8.7%), respectively.
  • In the ≤65 kg subgroup, there was no increase in the incidence of infections for any grade TEAEs (DARZALEX FASPRO, 57.0%; DARZALEX, 57.6%), and grade 3/4 TEAEs (DARZALEX FASPRO, 10.8%; DARZALEX, 17.4%).
  • In the ≤65 kg subgroup, incidence of serious infections was 10.8% vs 18.5% in the DARZALEX FASPRO vs DARZALEX arms, respectively.
• Rate of IRRs was lower in the DARZALEX FASPRO arm (12.7%; n=33) vs DARZALEX arm (34.5%; n=89); (OR, 0.28; 95% CI, 0.18-0.44; P<0.0001).
• One injection-site reaction was reported in the DARZALEX FASPRO arm.
• There were no reports of IRRs in patients who switched from DARZALEX to DARZALEX FASPRO (n=13).

PPK and E-R Analysis

Luo et al (2019)³ evaluated PPK and E-R analysis to compare DARZALEX FASPRO vs DARZALEX in patients with RRMM from PAVO⁵, MMY1008⁶, and COLUMBA study.

Results

Patient Characteristics

• To measure PPK, serum concentration-time data were used for nonlinear mixed-effects modeling.
• Daratumumab exposure and the covariate effects were assessed by subgroup analysis and measured as ± 20% of geometric mean of predicted cycle 3 day 1 C_trough. See in Table: Descriptive Statistics of Baseline Categorical and Continuous Covariates.
• E-R analysis was evaluated by comparing the ORR of daratumumab SC and IV.
• The E-R for safety analysis was conducted by evaluating serious AEs, grade ≥3 TEAEs, and neutropenia.
• Overall peak and peak after first dose daratumumab concentrations were evaluated for their potential relationship with AEs by exposure quartiles.  

PPK Analysis

• The PPK analysis was based on 4,385 PK samples from 543 patients (DARZALEX FASPRO, n=288; DARZALEX, n =255).
• DARZALEX FASPRO dosing demonstrated similar or slightly higher C_trough compared to DARZALEX with lower maximum concentrations (C_max) and smaller peak-to-through fluctuations throughout the dosing schedule.
  • The mean peak-to-trough ratio was 1.2 vs 1.7 for DARZALEX FASPRO vs DARZALEX on cycle 3 day 1.
• A subgroup analysis of predicted cycle 3 day 1 C_trough for DARZALEX FASPRO demonstrated differences in baseline albumin level, ECOG performance status, and type of myeloma subgroups. However further clinical subgroup analysis was consistent with data from DARZALEX studies and no clinically relevant effects.

E-R Analysis

• In the E-R Analyses, DARZALEX FASPRO demonstrated a similar E-R relationship for efficacy as data produced a similar or slightly higher cycle 3 day 1 C_trough in both responders and non-responders.
• No relationship was established between exposure and safety endpoints after the first dose peak concentrations.
• DARZALEX FASPRO demonstrated slightly higher cycle 3 day 1 C_trough in lower body weight subgroups compared to DARZALEX group.

Treatment Satisfaction

Usmani et al (2021)⁴ presented results on the satisfaction of patients with therapy data collected via a patient-reported outcome instrument in the COLUMBA study.

Study Design/Methods

• The Cancer Therapy Satisfaction Questionnaire (CTSQ) was modified to include 9 items specific to patient-reported satisfaction with treatment and for comparison of SC and IV administration. The following 9 items were included in the modified CTSQ:
  • In the last 4 weeks, was the cancer therapy worth taking, despite side effects?
  • In the last 4 weeks, how often did you think about stopping your cancer therapy?
  • Overall, how worthwhile was your cancer therapy?
  • Overall, was taking cancer therapy as difficult as you expected?
  • Overall, how well did the benefits of cancer therapy meet your expectations?
  • Overall, were the side effects of cancer therapy as you expected?
  • How satisfied were you with the form of your cancer therapy?
  • Overall, how satisfied were you with your most recent cancer therapy?
  • Taking everything into consideration, if given the choice again, would you decide to take this cancer therapy treatment?
• Patients completed a modified paper CTSQ at weekly (cycles 1-2, starting on cycle 1 day 8) and monthly (cycles 3+) time points and at the end of treatment.
• Scores were presented for cycles 1-10 for each cohort in the intent-to-treat (ITT) population as few patients reached later cycles at the time of analysis.

Results

Patient Characteristics

• The ITT population consisted of 259 patients randomized to DARZALEX and 263 to DARZALEX FASPRO.
• Demographic and clinical characteristics were balanced except for cytogenetic risk.

Patient Satisfaction With Therapy

• Mean scores for the Satisfaction With Therapy (SWT) domain were higher for DARZALEX FASPRO vs DARZALEX for all time points assessed.
• More DARZALEX FASPRO patients reported positive responses to the following 3 most relevant components of the SWT domain that assessed the effect of the route of administration on patient satisfaction with therapy: “Satisfied With Form of Cancer Therapy (IV/SC)”, “Taking Cancer Therapy as Difficult as Expected”, and “Were Side Effects as Expected.”
  • There was little or no overlap between treatment groups in the range of mean values over time for these components.
• More favorable scores were reported for DARZALEX FASPRO patients for the remaining 4 items of the SWT domain of the modified CTSQ, including “Satisfied With Most Recent Cancer Therapy” (which was assumed to be the study drug), “How Worthwhile Was Cancer Therapy,” “Benefits Meet Expectations,” and “Would You Take This Cancer Therapy Again.”
• Single item scores on the modified CTSQ from the Thoughts About Cancer Therapy domain were consistent over time within each treatment group (“Worth Taking Even With Side Effects” and “Thinking About Stopping Cancer Therapy”); no domain score was calculated.
• There were small numeric differences in mean values between treatment groups for “Thinking About Stopping Cancer Therapy” that favored DARZALEX FASPRO.

Subgroup Analysis in Asian Patients

Iida et al (2021)⁷ conducted exploratory subgroup analyses in Asian patients (n=67) and a separate analysis for Japanese patients (n=42) from the COLUMBA study.

Study Design/Methods

• The eligibility criteria were the same as in the COLUMBA study as described above. Patients were randomized according to the planned stratification factors described above (bodyweight, number of prior lines of therapy, type of myeloma).
• Additionally, a separate sub analysis of Japanese patients (n=42) was conducted. Please see the section Japanese Patients Subgroup Analysis of the COLUMBA Study for results specific to the Japanese patients that participated in the COLUMBA study.

Results

Baseline Characteristics  Asian Subgroup

• Of the 62 Asian patients (12.8%) in the COLUMBA study (N=522), 11 were Korean, 14 were Taiwanese and 42 were Japanese patients.
• After a median follow-up of 13.7 months, median PFS was 11.1 months in the DARZALEX FASPRO arm and 6.6 months in the DARZALEX arm (HR, 0.62; 95% CI, 0.32-1.22; P=0.1613).
• Discontinuation of treatment: 46.7% (n=14) in the DARZALEX FASPRO arm and 62.2% (n=23) in the DARZALEX arm. Reasons for discontinuation were progressive disease (DARZALEX FASPRO, n=11; DARZALEX, n=19), AE, patient decision, physician decision (n=1 each). One death was reported in the DARZALEX arm.
• In general, Asian patients in the DARZALEX FASPRO arm were more satisfied with their treatment than patients in the DARZALEX arm.

Efficacy

• The median maximum C_trough at cycle 3 day 1 was 729 μg/mL (range, 352-1543) in the DARZALEX FASPRO arm 621 μg/mL (range, 120-1036) in the DARZALEX arm. In the bodyweight subgroups, the median maximum C_trough was:
  • ≤55 kg subgroup: 941 μg/mL (range, 360-1543) in DARZALEX FASPRO and 540 (range, 197-883) in the DARZALEX arm.
  • ≤65 kg subgroup: 803 μg/mL (range, 352-1543) in the DARZALEX FASPRO and 540 μg/mL (range, 120-938) in the DARZALEX arm.
  • >65-85 kg subgroup: 526 μg/mL (range, 378-640) in the DARZALEX FASPRO and 648 μg/mL (range, 438-1036) in the DARZALEX arm.

Safety

• The rates of IRR were 10% in the DARZALEX FASPRO arm and 18.9% in the DARZALEX arm.
• The incidence of any-grade infections was 66.7% in the DARZALEX FASPRO arm and 67.6% in the DARZALEX arm.⁹
• The DARZALEX arm had a higher rate of grade 3/4 infections vs DARZALEX FASPRO arm (16.2% vs 3.3%, respectively).^7,9
  • Infection prophylactic treatment was used in 51.4% of patients in the DARZALEX arm and 60.4% in the DARZALEX FASPRO arm. No deaths due to infection or neutropenic sepsis were reported in the either arm.  
• One patient in the DARZALEX FASPRO arm discontinued due to TEAE (increases alanine and aspartate aminotransferase). One patient in the DARZALEX arm discontinued to TEAE (hepatitis B reactivation).
• The incidence of SAEs was 13.3% in the DARZALEX FASPRO arm and 40.5% in DARZALEX arm.

Japanese Patients Subgroup Analysis of the COLUMBA Study

Baseline Characteristics

• The median PFS was 8.3 months in the DARZALEX FASPRO arm and 9.3 months in the DARZALEX arm (HR, 0.89; 95% CI, 0.36-2.16; P=0.7870).
• Discontinuation of treatment: 9 patients in DARZALEX FASPRO and 12 in DARZALEX arm. Reasons for discontinuation were progressive disease (DARZALEX FASPRO, n=7; DARZALEX, n=12), death (DARZALEX, n=1), patient decision, physician decision (n=1 in each arm).
• Median duration of treatment was 6.5 months in DARZALEX FASPRO arm and 6.4 months in DARZALEX.
• Median completed treatment cycles was 8 in the both arms.

Efficacy

• ORR was 61.1% in DARZALEX FASPRO arm and 54.2% in DARZALEX arm.
• Median maximum C_trough at cycle 3 day 1 was 814 (range, 360-1543) μg/mL in the DARZALEX FASPRO arm and 592 (range, 260-1036) μg/mL in the DARZALEX arm. In the bodyweight groups the median maximum C_trough was:
  • ≤55 kg: 887 (range, 360-1543) μg/mL in the DARZALEX FASPRO arm and 540 (range, 328-883) μg/mL in the DARZALEX arm
  • ≤65 kg: 814 (range, 360-1543) μg/mL in the DARZALEX FASPRO arm and 540 (range, 260-883) μg/mL in the DARZALEX arm.
  • >65-85 kg: 648 (range, 438-1036) μg/mL in the DARZALEX arm. No patients in the DARZALEX FASPRO arm were PK evaluable.

Safety

• Grade 3/4 cytopenias occurred mostly in the lower bodyweight group.  
• The rate of IRRs was 16.7% in both the DARZALEX FASPRO arm and DARZALEX arm.
• Infections (any-grade) were reported in 58.3% of patients in the DARZALEX FASPRO arm and 61.1% in the DARZALEX arm. Grade 3/4 infections were reported in 5.6% of patients in the DARZALEX FASPRO arm and 8.3% in the DARZALEX arm.
• No patients discontinued treatment discontinued due to TEAEs.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 03 February 2025.