AML: pazopanib demonstrates limited efficacy in phase 2 study

  • Kessler T & al.
  • Ann Hematol
  • 21 Mar 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • In a phase 2 study of patients with relapsed/refractory (R/R) and newly diagnosed acute myeloid leukemia (AML) who were unsuitable for intensive therapy, pazopanib was well tolerated but demonstrated limited efficacy.

Why this matters

  • After complete response, most patients with AML experience relapse within 1-2 years of initiating therapy; new treatment options are needed.
  • Pazopanib is an oral adenosine triphosphate (ATP)-competitive tyrosine kinase inhibitor (TKI) currently approved for the treatment of renal cancer.

Study design

  • Phase 2 study to investigate pazopanib in 25 patients with AML who were ineligible for intensive therapy.
  • Median patient age: 76 (range, 52-86) years.
  • 15 (75%) patients had R/R disease; 25% had newly diagnosed disease.
  • Funding: GSK; Novartis, Germany.

Key results

  • No significant decrease in bone marrow (BM) microvessel density (P=.677).
  • Pazopanib-associated grade 3 adverse events included nausea (n=2), fatigue (n=3), hypertension (n=1), and increased blood bilirubin (n=1).
  • 10% of patients achieved partial response (defined as >50% reduction in elevated blast counts in peripheral blood and bone marrow vs baseline).
  • Median PFS: 65 (95% CI, 29-105) days.
  • Median OS: 191 (95% CI, 87-435) days.
  • 35% 1-year survival.

Limitations

  • Single-group study design.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.

Submit