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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Although both studies were terminated early, these results indicate that sotatercept is active and has an acceptable safety profile in the treatment of CIA.
authors.affiliation: Monter Cancer Center, Hofstra North Shore-LIJ School of Medicine, 450 Lakeville Road, Lake Success, NY, 11042, USA. harry.raftopoulos@gmail.com.
authors.forename: Haralambos
authors.initials: H
authors.lastname: Raftopoulos
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: Abderrahmane
authors.initials: A
authors.lastname: Laadem
authors.affiliation: Lahey Hospital & Medical Center, Tufts University School of Medicine, Burlington, MA, USA.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Hesketh
authors.affiliation: Blue Ridge Cancer Care, Blacksburg, VA, USA.
authors.forename: Jerome
authors.initials: J
authors.lastname: Goldschmidt
authors.affiliation: Gabrail Cancer Center, Canton, OH, USA.
authors.forename: Nashat
authors.initials: N
authors.lastname: Gabrail
authors.affiliation: Texas Oncology PA, Dallas, TX, USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Osborne
authors.affiliation: Quincy Medical Group, Quincy, IL, USA.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Ali
authors.affiliation: Acceleron Pharma, Cambridge, MA, USA.
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Sherman
authors.affiliation: Josephine Ford Cancer Institute, Detroit, MI, USA.
authors.forename: Ding
authors.initials: D
authors.lastname: Wang
authors.affiliation: UCLA Medical Center, Los Angeles, CA, USA.
authors.forename: John A
authors.initials: JA
authors.lastname: Glaspy
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: Marie
authors.initials: M
authors.lastname: Puccio-Pick
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: Jun
authors.initials: J
authors.lastname: Zou
authors.affiliation: Duke University Medical Center, Durham, NC, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Crawford
mesh_terms: D000328:Adult; D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy / Q000009:adverse effects*; D008875:Middle Aged; D010984:Platinum / Q000009:adverse effects; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D010984:Platinum; D011993:Recombinant Fusion Proteins; C542017:sotatercept
keywords: ActRIIA; Chemotherapy-induced anemia; Erythropoiesis; Sotatercept