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EMA grants anti-BCMA CAR T, JNJ-4528, PRIME designation in multiple myeloma 

Apr 9, 2019

It has been announced that JNJ-4528, an anti-B-cell maturation antigen (BCMA) CAR T-cell therapy has been granted priority medicines (PRIME) designation by the European Medicines Agency(EMA) for use in multiple myeloma (MM). 1

JNJ-4528, was previously named LCAR-B38M, and the PRIME designation is the result of the phase I/II LEGEND-2 study of LCAR-B38M, previously reported by the Multiple Myeloma Hub here. 1

LEGEND-2 study 1,2

  • Interim results of phase I multicenter study in China
  • Reported enrollment of 57 patients with relapsed/refractory MM (RRMM)
    • Patients received at least three prior treatments including; a proteasome inhibitor (PI), an immunomodulatory drug (IMiD) and daratumumab
    • Documented disease progression ≤12 months after starting most recent therapy or double-refractory to a PI and IMiD
    • Median age: 54 years (27–72)
    • Stage III disease: 37%
  • Data cut-off: 6 February 2018
  • Safety:

    • Patients experiencing ≥1 adverse event (AE): 100% (57/57)
    • Cytokine release syndrome (CRS) occurred in 90% patients (51/57)
      • CRS ≥ grade 3: 7% (4/57)
      • One grade 5 fatal event (1/57)
    • Grade ≥3 AEs were reported in 65% of patients (37/57)
    • Most common AEs grade ≥3 (in >20% of patients):
      • Leukopenia: 30% (17/57)
      • Thrombocytopenia: 23% (13/57)
      • Aspartate aminotransferase increase: 21% (12/57)
  • Efficacy:

    • Follow-up: 8 months
    • Overall response rate: 88% (50/57, 95% CI, 76–95)
      • Complete response (CR): 68% (39/57, 95% CI, 55–80)
      • Very good partial response (VGPR): 5% (3/57, 95% CI, 1–15)
      • Partial response (PR): 14% (8/57, 95% CI, 6–26)
    • Median progression-free survival (PFS): 15 months (95% CI, 11–not estimable)
    • Median time to initial response: 1 month
    • Median overall survival was not reached

The PRIME designation will speed-up the evaluation of JNJ-4528 and will aim to bring this therapy to patients as soon as possible based on the high unmet medical need. 3

  1. Pharmaphorum. EU regulators to fast-track Janssen’s multiple myeloma CAR-T. https://pharmaphorum.com/news/eu-regulators-to-fast-track-janssens-multiple-myeloma-car-t/[accessed 2019 Apr 05]
  2. Zhao W. H. et al., A phase I, open-label study of LCAR-B38M, a chimeric antigen receptor T cell therapy directed against B cell maturation antigen, in patients with relapse or refractory multiple myeloma. J Hematol Oncol. 2018 Dec 20; 11:141. DOI: 10.1186/s13045-018-0681-6
  3. EMA. PRIME – PRIORITY MEDICINES. https://www.ema.europa.eu/en/documents/leaflet/prime-paving-way-promising-medicines-patients-factsheet_en.pdf[accessed 2019 Apr 05]