General AML

Highlights from ASH 2016: Abstract 100 – A Phase II Study of Pracinostat and Azacitidine in Elderly Patients with AML Not Eligible for Induction Chemotherapy: Response and Long-Term Survival Benefit

On Saturday 3rd December, at the 58th Annual Meeting & Exposition of the American Society of Hematology (ASH) in San Diego, CA, there was a gripping session focusing on “Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation.”

Guillermo Garcia-Manero, MD, of the Department of Leukemia at The University of Texas M.D. Anderson Cancer Center, Houston, USA, presented the key findings from a phase II study of pracinostat and azacitidine. Pracinostat is a potent oral Class I, II, IV Histone Deacetylase (HDAC) inhibitor and azacitidine (AZA) is a novel hypomethylating agent. Garcia-Manero et al. investigated the combination of these agents in 50 older patients (median age 75 years) unable to undergo induction chemotherapy.

The findings were:

  • Complete Response (CR) was achieved in 21 patients
  • CR with incomplete blood count recovery (CRi) in 2 patients
  • Morphologic Leukemia Free status (MLFs) in 3 patients
  • cCR rate of 52%
  • Median duration of cCR was 13.2 months

  • Median Overall Survival (OS) was 19.1 months, 1-year and 2-year OS were 62% and 41%, respectively

  •  OS by cytogenetic risk group, high vs intermediate; 13.5 months vs 24.1 months

  • OS in de novo vs secondary AML, 13.0 months vs 19.6 months

  •  OS in ≥ 75 years vs < 75 years; 13.5 months vs 22.8 months 

  • OS by ECOG Performance Status (PS), PS 0–1 vs PS 2; 19.1 months vs 13.0 months

  • Thrombocytopenia was the most common grade ≥ 3 hematologic adverse event (46%)

The authors concluded that pracinostat + AZA led to a high rate of response in elderly patients with AML. Furthermore, the responses were durable and observed irrespective of age, cytogenetic risk, ECOG performance status, and de novo or secondary AML.

References
  1. Garcia-Manero G. et al. A Phase 2 Study of Pracinostat and Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML) Not Eligible for Induction Chemotherapy: Response and Long-Term Survival Benefit. Oral Abstract #100: ASH 58th Annual Meeting and Exposition, San Diego, CA.