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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