20 people in clinical trial and to more than double:
“Cellectar Announces Data From 20 Patients Receiving a Single 25mCi/M2 Bolus Dose of CLR 131 in the Phase 2 CLOVER-1 Study
BY GlobeNewswire
— 8:00 AM ET 12/16/2019
30% overall response rate seen with an average progression free survival of 4.5 months and an acceptable and expected safety profile
Additional data in patients receiving higher fractionated doses of CLR 131 anticipated in January
FLORHAM PARK, N.J., Dec. 16, 2019 (GLOBE NEWSWIRE) -- Cellectar Biosciences ( CLRB
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), Inc. , a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced summary data from 20 patients receiving a single dose of CLR 131 in its Phase 2 CLOVER-1 trial in select relapsed/refractory (RR) B-cell malignancies. The company had previously announced data from 10 multiple myeloma patients receiving a single dose of CLR 131 in February 2019, which showed a 30% overall response rate (ORR).
The Phase 2 CLOVER-1 study is designed to identify a safe and efficacious dose and regimen to be used in a pivotal study for select hematologic indications. The 20 evaluated patients, included 10 subjects with relapsed/refractory multiple myeloma, and 10 with relapsed/refractory B-cell lymphoma. The median age was 71 (range 52-82), including 7 females and 13 males, with a median of 6 prior systemic therapies for multiple myeloma and 4 for patients with lymphoma. Eight patients had prior autologous stem cell transplant therapy. Data from these 20 patients showed a 30% ORR, a 75% clinical benefit rate, an average progression free survival of 4.5 months and an acceptable and expected safety profile.
“The 30% ORR seen suggests that CLR 131 treatment at the single 25 mCi/m2 bolus dose may have activity in these heavily pre-treated patients,” said James Caruso, president and CEO of Cellectar Biosciences ( CLRB
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). “We recently presented data at ASH on 19 patients with relapsed, refractory multiple myeloma, which showed improved efficacy and safety with fractionated doses vs. the single bolus dose, and patients receiving a fractionated dose of 37.5mCi showed a 50% ORR. As background, recently approved drugs for this indication have demonstrated approximate ORRs of 25% in a similar patient population and up to 29% as a third line treatment. We plan to provide additional data in patients who are receiving higher fractionated doses of CLR 131 in January.”
The primary adverse events (AEs) seen were cytopenias, including thrombocytopenia, anemia, neutropenia, and decreased white blood cell count. The hematologic AEs were expected, manageable and followed a predictable timeline to nadir (average 49 days) and subsequent recovery (average 16 days post nadir). Patients with disease in the bone marrow experienced more cytopenias than did patients with no detectable disease in the bone marrow. All patients recovered from the cytopenias.”
