ACHIEVING CLINICALLY RELEVANT PLATELET COUNT RESPONSE THRESHOLDS WITH AVATROMBOPAG (AVA) IN IMMUNE THROMBOCYTOPENIA (ITP)
Author(s): ,
Ivy Altomare
Affiliations:
Division of Medical Oncology,Duke University Medical Center,Durham,United States;Duke Cancer Center,Durham,United States
,
Michael Vredenburg
Affiliations:
Dova Pharmaceuticals,Durham,United States
,
Wei Tian
Affiliations:
Dova Pharmaceuticals,Durham,United States
Kavita Aggarwal
Affiliations:
Dova Pharmaceuticals,Durham,United States
(Abstract release date: 05/14/20) EHA Library. Vredenburg M. 06/12/20; 294141; EP1660
Michael Vredenburg
Michael Vredenburg
Contributions
Abstract

Abstract: EP1660

Type: e-Poster

Background
Thrombopoietin receptor agonists (TPO-RAs) are safe and effective treatments for refractory chronic ITP. Unlike other TPO-RAs, AVA does not require a fasting state nor weekly visits for in-office administration.  A platelet count ≥50,000/µL is often the target endpoint designated in ITP clinical trials; however in real-world practice a PC of 30,000/µL or above is often thought adequate to achieve safety and reduce the risk of serious bleeding.

Aims
The objective of these analyses was to evaluate the ability of AVA to achieve a platelet count ≥30,000/µL in ITP patients.

Methods
A randomized, double-blind, Phase 3 study enrolled 32 AVA and 17 placebo-treated patients with chronic ITP.  The primary endpoint was the cumulative number of weeks in which the platelet count was ≥50,000/µL during the 6-month treatment period in the absence of rescue therapy.  Post-hoc efficacy outcomes were evaluated to assess achieving a platelet count ≥30,000/µL.

Results
Treatment with AVA resulted in more patients achieving a platelet count ≥30,000/µL at least once or twice during the 6 months as compared with placebo (Table 1). The median cumulative number of weeks with a platelet count ≥30,000/µL without requiring rescue treatment was 21.1 for AVA-treated patients and 0.0 for placebo.  The median consecutive number of weeks maintaining a platelet count ≥30,000/µL was 11.1 for AVA and 0.0 for placebo.  64.0% of AVA vs. 0.0% of placebo-treated patients experienced a durable platelet response, achieving a platelet count ≥30,000/µL for 6 of the final 8 weeks of the study.  

Conclusion
When compared with placebo, treatment with AVA demonstrated robust and durable efficacy in reaching a platelet count of ≥30,000/µL, a key threshold for clinicians as they evaluate the effectiveness of ITP therapy and make therapeutic management decisions.  

Session topic: 32. Platelets disorders

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

Abstract: EP1660

Type: e-Poster

Background
Thrombopoietin receptor agonists (TPO-RAs) are safe and effective treatments for refractory chronic ITP. Unlike other TPO-RAs, AVA does not require a fasting state nor weekly visits for in-office administration.  A platelet count ≥50,000/µL is often the target endpoint designated in ITP clinical trials; however in real-world practice a PC of 30,000/µL or above is often thought adequate to achieve safety and reduce the risk of serious bleeding.

Aims
The objective of these analyses was to evaluate the ability of AVA to achieve a platelet count ≥30,000/µL in ITP patients.

Methods
A randomized, double-blind, Phase 3 study enrolled 32 AVA and 17 placebo-treated patients with chronic ITP.  The primary endpoint was the cumulative number of weeks in which the platelet count was ≥50,000/µL during the 6-month treatment period in the absence of rescue therapy.  Post-hoc efficacy outcomes were evaluated to assess achieving a platelet count ≥30,000/µL.

Results
Treatment with AVA resulted in more patients achieving a platelet count ≥30,000/µL at least once or twice during the 6 months as compared with placebo (Table 1). The median cumulative number of weeks with a platelet count ≥30,000/µL without requiring rescue treatment was 21.1 for AVA-treated patients and 0.0 for placebo.  The median consecutive number of weeks maintaining a platelet count ≥30,000/µL was 11.1 for AVA and 0.0 for placebo.  64.0% of AVA vs. 0.0% of placebo-treated patients experienced a durable platelet response, achieving a platelet count ≥30,000/µL for 6 of the final 8 weeks of the study.  

Conclusion
When compared with placebo, treatment with AVA demonstrated robust and durable efficacy in reaching a platelet count of ≥30,000/µL, a key threshold for clinicians as they evaluate the effectiveness of ITP therapy and make therapeutic management decisions.  

Session topic: 32. Platelets disorders

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

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