RESPONSE TO AVATROMBOPAG (AVA) IN CHRONIC IMMUNE THROMBOCYTOPENIA: ALTERNATIVE EFFICACY MEASURES
Author(s): ,
Hillary Maitland
Affiliations:
Division on Hematology/Oncology,University of Virginia,Charlottesville,United States
,
Kavita Aggarwal
Affiliations:
Dova Pharmaceuticals,Durham,United States
,
Michael Vredenburg
Affiliations:
Dova Pharmaceuticals,Durham,United States
,
Wei Tian
Affiliations:
Dova Pharmaceuticals,Durham,United States
Nashat Gabrail
Affiliations:
Gabrail Cancer Center,Canton,United States
(Abstract release date: 05/14/20) EHA Library. Vredenburg M. 06/12/20; 294140; EP1659
Michael Vredenburg
Michael Vredenburg
Contributions
Abstract

Abstract: EP1659

Type: e-Poster

Background
Immune thrombocytopenia (ITP) is an acquired bleeding disorder caused by immune-mediated platelet destruction and insufficient platelet production.  AVA is an oral thrombopoietin receptor agonist (TPO-RA) approved for the treatment of chronic ITP when a patient has had insufficient response to a prior therapy.  A better understanding of the efficacy profile for AVA will help clinicians make treatment decisions for their patients.

Aims
The objective of these analyses was to evaluate the efficacy of AVA treatment in ITP patients using alternative measurements that may be clinically meaningful.  

Methods

A 6-month, multicenter, randomized, double-blind, Phase 3 study enrolled 32 AVA and 17 placebo-treated patients with ITP.  The primary endpoint was the median number of cumulative weeks of platelet count (PC) response (achieving a PC ≥50,000/µL) over the course of the study without rescue medication.  Patients receiving any rescue medication during the study were deemed to be non-responders for the remainder of the study.  These post-hoc analyses evaluate the ability to achieve a PC of ≥50,000/µL once or twice during the course of the study and consecutive weeks of PC ≥50,000/µL.    

Results
87.5% of AVA versus 5.9% of placebo-treated patients attained a PC ≥50,000/µL at least once during the study.  81.3% of AVA-treated patients were able to achieve this PC response level at least twice in comparison to 0.0% with placebo.  53.3% of patients had a PC ≥50,000/µL for at least 4 consecutive weeks, as opposed to 0.0% with placebo.  The mean number of weeks of continuous platelet response was 6.5 for AVA versus 0.1 for placebo-treated patients.  

Conclusion
AVA effectively increases PCs in patients with ITP and the majority of treated patients achieved a sustained platelet response. Results of this analysis may be more meaningful for HCPs who understand that treatment of chronic ITP requires constant monitoring and dose modifications to manage PCs. 

Session topic: 32. Platelets disorders

Keyword(s): Bleeding disorder, Immune thrombocytopenia (ITP), Thrombopoietin (TPO)

Abstract: EP1659

Type: e-Poster

Background
Immune thrombocytopenia (ITP) is an acquired bleeding disorder caused by immune-mediated platelet destruction and insufficient platelet production.  AVA is an oral thrombopoietin receptor agonist (TPO-RA) approved for the treatment of chronic ITP when a patient has had insufficient response to a prior therapy.  A better understanding of the efficacy profile for AVA will help clinicians make treatment decisions for their patients.

Aims
The objective of these analyses was to evaluate the efficacy of AVA treatment in ITP patients using alternative measurements that may be clinically meaningful.  

Methods

A 6-month, multicenter, randomized, double-blind, Phase 3 study enrolled 32 AVA and 17 placebo-treated patients with ITP.  The primary endpoint was the median number of cumulative weeks of platelet count (PC) response (achieving a PC ≥50,000/µL) over the course of the study without rescue medication.  Patients receiving any rescue medication during the study were deemed to be non-responders for the remainder of the study.  These post-hoc analyses evaluate the ability to achieve a PC of ≥50,000/µL once or twice during the course of the study and consecutive weeks of PC ≥50,000/µL.    

Results
87.5% of AVA versus 5.9% of placebo-treated patients attained a PC ≥50,000/µL at least once during the study.  81.3% of AVA-treated patients were able to achieve this PC response level at least twice in comparison to 0.0% with placebo.  53.3% of patients had a PC ≥50,000/µL for at least 4 consecutive weeks, as opposed to 0.0% with placebo.  The mean number of weeks of continuous platelet response was 6.5 for AVA versus 0.1 for placebo-treated patients.  

Conclusion
AVA effectively increases PCs in patients with ITP and the majority of treated patients achieved a sustained platelet response. Results of this analysis may be more meaningful for HCPs who understand that treatment of chronic ITP requires constant monitoring and dose modifications to manage PCs. 

Session topic: 32. Platelets disorders

Keyword(s): Bleeding disorder, Immune thrombocytopenia (ITP), Thrombopoietin (TPO)

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