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- Title
Sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia in patients with metastatic breast cancer or advanced or metastatic solid tumors treated with platinum-based chemotherapeutic regimens: results from two phase 2 studies.
- Authors
Raftopoulos, Haralambos; Glaspy, John; Crawford, Jeffrey; Laadem, Abderrahmane; Puccio-Pick, Marie; Zou, Jun; Hesketh, Paul; Goldschmidt, Jerome; Gabrail, Nashat; Osborne, Cynthia; Ali, Muhammad; Sherman, Matthew; Wang, Ding; Hesketh, Paul J; Sherman, Matthew L; Glaspy, John A
- Abstract
<bold>Purpose: </bold>Sotatercept may represent a novel approach to the treatment of chemotherapy-induced anemia (CIA). We report the results from two phase 2 randomized studies examining the use of sotatercept for the treatment of CIA in patients with metastatic cancer.<bold>Methods: </bold>In study A011-08, patients with metastatic breast cancer were randomized to 2:2:2:1 to receive sotatercept 0.1, 0.3, or 0.5 mg/kg, or placebo, respectively, every 28 days. In study ACE-011-NSCL-001, patients with solid tumors treated with platinum-based chemotherapy received sotatercept 15 or 30 mg every 42 days. The primary endpoint for both studies was hematopoietic response, defined as a hemoglobin (Hb) increase of ≥1 g/dL from baseline.<bold>Results: </bold>Both studies were terminated early due to slow patient accrual. Among patients treated with sotatercept in the A011-08 and ACE-011-NSCL-001 studies, more patients achieved a mean Hb increase of ≥1 g/dL in the combined sotatercept 0.3 mg/kg and 15 mg (66.7 %) group and sotatercept 0.5 mg/kg and 30 mg (38.9 %) group versus the sotatercept 0.1 mg/kg (0 %) group. No patients achieved a mean Hb increase of ≥1 g/dL in the placebo group. The incidence of treatment-related adverse events (AEs) was low in both studies, and treatment discontinuations due to AEs were uncommon.<bold>Conclusions: </bold>Although both studies were terminated early, these results indicate that sotatercept is active and has an acceptable safety profile in the treatment of CIA.
- Subjects
CHEMOTHERAPY complications; ERYTHROPOIESIS; METASTASIS; ANEMIA; CANCER treatment; PATIENTS; ANTINEOPLASTIC agents; BREAST tumors; COMPARATIVE studies; RESEARCH methodology; MEDICAL cooperation; PLATINUM; RECOMBINANT proteins; RESEARCH; STATISTICAL sampling; EVALUATION research; RANDOMIZED controlled trials; BLIND experiment; THERAPEUTICS
- Publication
Supportive Care in Cancer, 2016, Vol 24, Issue 4, p1517
- ISSN
0941-4355
- Publication type
journal article
- DOI
10.1007/s00520-015-2929-9