SUMMARY

• DARZALEX is not approved by the regulatory agencies for use in plasmablastic lymphoma (PBL). Janssen does not recommend the use of DARZALEX in a manner that is inconsistent with the approved labeling.
• A phase 2 study is being conducted to evaluate the activity and safety of DARZALEX in combination with bortezomib and dexamethasone in patients with relapsed or refractory PBL (NCT04915248).¹ Results have yet to be published.
• An early phase 1 study is being conducted to evaluate DARZALEX in combination with dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (DA-EPOCH) for the treatment of patients with newly diagnosed stage I-IV PBL (NCT04139304).² Study results have not been published yet.
• Ryu et al (2022)³ retrospectively evaluated the efficacy and safety of DARZALEX-based regimens in 7 patients with advanced stage PBL (evaluable, n=6; classic PBL, n=4; patients who did not meet the stringent criteria for PBL per the World Health Organization [WHO] classification, n=2).
  • At baseline, the median age of included patients was 48 years, 7 patients had extranodal sites of disease, 4 had Eastern Cooperative Oncology Group (ECOG) scores of 3 or 4 at diagnosis, and 5 were cluster of differentiation 38 (CD38) positive.
  • Five patients received 6 cycles of DARZALEX with DA-EPOCH, and 1 patient received weekly DARZALEX followed by the addition of weekly bortezomib with DARZALEX.
  • All evaluable patients achieved complete response (CR), and 4 patients who had completed treatment continued to be in remission.
  • At data cutoff, the median duration of response (DOR) among the evaluable patients was 16.8 months, and all were continuing to respond.
    • The median DOR was 23.7 months in patients with classic PBL and 3 months in patients who did not meet the stringent criteria for PBL.
  • The median overall survival (OS) and median progression-free survival (PFS) were not reached in patients with classic PBL (except for 1 patient who died of illicit drug use, asthma exacerbation, and respiratory arrest) and were 7 months and 6 months, respectively, in patients who did not meet the stringent criteria for PBL.
    • Patients who did not meet the stringent criteria for PBL relapsed shortly after treatment completion and died.
  • The 24-month OS rate was 57% among all evaluable patients, including those who died of nontreatment and nondisease-related causes.
  • Grade 3/4 adverse events were reported in 6 out of 7 patients. No treatment-related deaths were reported.
    • With the first infusion of DARZALEX, infusion-related reactions were reported in 2 patients (rash and pruritus, n=1; bradycardia, n=1).
• Castillo et al (2019)⁴ evaluated the efficacy and safety of bortezomib in combination with DA-EPOCH in 16 patients with PBL in a multicentered, retrospective review of medical records.
  • Salvage therapy was provided to 1 patient and included the use of DARZALEX in combination with ifosfamide, carboplatin, and etoposide (ICE), followed by autologous stem cell transplant. CR was achieved by the patient who remained alive at 15 months after salvage therapy.
• Several case reports have been published describing patients with PBL who received DARZALEX as part of treatment. The reports are included in the References section for your information.^5–18

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 6 August 2024.