Relapsed/refractory patients

Top-line results from the phase II study of CLR 131 – CLOVER-1

CLR 131 is a radioiodinated phospholipid ether-drug conjugate that utilizes malignant cells selective uptake and retention of phospholipid ethers. The use of CLR 131 is being investigated in the CLOVER-1 study in patients with relapsed/refractory (RR) B-cell hematologic cancers including multiple myeloma (MM). CLOVER-1 is an open-label, multicentre, phase II study. The top-line results from the study in patients with RRMM have been announced and are provided here.1

Background on the study (NCT02952508)1,2
  • CLR 131 is being investigated in multiple B-cell hematologic cancers
  • Enrolled patients with RRMM must have received at least 2 prior regimens including 1 proteasome inhibitor and 1 immunomodulatory agent
  • Primary endpoints:
    • Clinical benefit response
    • Overall response rate (ORR)
    • Progression-free survival
    • Median overall survival
  • Dose: 15.625 mCi/m2 administered intravenously on days 1 and 8
    • Determined based on phase I results of cohort 5 (patients with RRMM)
  • Patients also receive 40mg oral dexamethasone weekly for up to 12 weeks
Phase II top-line results1
  • Patients received a dose of 25 mCi/m2 of CLR 131, administered as a single 30-minute infusion on days 1 and 8
  • Median number of prior lines of therapy: 5
  • Efficacy:
    • ORR (N = 10): 30%
    • Very good partial response: N = 1
    • Partial response: N = 2

The pharmaceutical company responsible for the trial continue to dose patients at higher fractionated doses with data from other cohorts expected to be announced later this year.

References
  1. Cellectar Reports Positive Top-line Response Rate of 30% from R/R Multiple Myeloma Cohort in Ongoing Phase 2 Study of CLR 131. https://globenewswire.com/news-release/2019/02/25/1741555/0/en/Cellectar-Reports-Positive-Top-line-Response-Rate-of-30-from-R-R-Multiple-Myeloma-Cohort-in-Ongoing-Phase-2-Study-of-CLR-131.html [accessed 2019 Feb 26]
  2. Study of CLR 131 in Relapsed or Refractory Select B-Cell Malignancies (CLOVER-1). https://clinicaltrials.gov/ct2/show/NCT02952508 [accessed 2019 Feb 26]
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