Graft-versus-host disease – clinical ePoster with Audio

O088 - INTERIM ANALYSIS OF KD025-213: A PHASE 2, RANDOMIZED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF KD025 IN SUBJECTS WITH CGVHD (THE ROCKSTAR STUDY) (ID 1133)

Authors
  • C. Cutler
  • Z. DeFilipp
  • A. Salhotra
  • R. Mehta
  • T. Wang
  • W. Chai-ho
  • M. Arora
  • N. Shah
  • I. Pusic
  • C. Bachier
  • A. Langston
  • S. Abhyankar
  • A. Saad
  • A. Im
  • J. Galvin
  • A. Logan
  • L. Schachter
  • J. Liesveld
  • M. Juckett
  • A. Alavi
  • D. Howard
  • L. Green
  • O. Schueller
  • B. Blazar
  • S. Pavletic
  • S. Lee
  • Z. Yang
  • D. Eiznhamer
  • S. Aggarwal
  • M. Jagasia

Abstract

Background: KD025 is an orally available Rho-associated coiled-coil kinase 2 (ROCK2) selective inhibitor that decreases pro-inflammatory Stat3 and increases Stat5 favoring regulatory T cells. Previous data (KD025-208, NCT02841995) supported efficacy and tolerability in cGVHD after 1-3 prior lines of systemic therapy (LOT).
 

Methods: We randomly assigned cGVHD patients (pts) after 2-5 prior LOT to KD025 200mg QD (n=66), or KD025 200mg BID (n=66), across 28 sites, stratified according to cGVHD severity and prior ibrutinib. The primary endpoint was the overall response rate (ORR) per 2014 NIH response criteria, assessed by investigators. Additional endpoints include Duration of Response, Lee Symptom Scale (LSS) score, corticosteroid reductions, FFS and OS. Treatment was until clinically significant progression or unacceptable toxicity. A pre-specified interim analysis (IA) occurred 2 months after the last pt was enrolled, with the primary analysis to occur 6 months after the last pt was enrolled.
 

Results: At this IA, median (range) duration of follow up was 5 (2, 12) months. Baseline characteristics are shown in the table below.

 

 

 

  KD025 BID (n=66) Median age [yrs (range)] 57 (21-77) Male 50% Median prior LOT 4 Median time from cGVHD Dx (mos) 30 Severe cGVHD [n (%)] 42 (64%) <span style="\&quot;font-weight:normal;" font-style:normal\"="">87 (66%)
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