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

• DOI: 10.1007/s00520-015-2929-9
• Publication Date: 2015-09-14T05:58:48Z
• Authors: Haralambos Raftop...; Abderrahmane Laadem; Paul J. Hesketh; Jerome Goldschmidt; Nashat Gabrail; Cynthia Osborne; Muhammad Ali; Matthew L. Sherman; Ding Wang; John A. Glaspy; Marie Puccio-Pick; Jun Zou; Jeffrey Crawford
• Keywords: Clinical endpoint

Sotatercept may represent a novel approach to the treatment of chemotherapy-induced anemia (CIA). We report results from two phase 2 randomized studies examining use sotatercept for CIA in patients with metastatic cancer.In study A011-08, breast cancer were 2:2:2:1 receive 0.1, 0.3, or 0.5 mg/kg, placebo, respectively, every 28 days. In ACE-011-NSCL-001, solid tumors treated platinum-based chemotherapy received 15 30 mg 42 The primary endpoint both was hematopoietic response, defined as hemoglobin (Hb) increase ≥1 g/dL baseline.Both terminated early due slow patient accrual. Among A011-08 and ACE-011-NSCL-001 studies, more achieved mean Hb combined 0.3 mg/kg (66.7 %) group (38.9 versus 0.1 (0 group. No placebo incidence treatment-related adverse events (AEs) low discontinuations AEs uncommon.Although early, these indicate that is active has an acceptable safety profile CIA.