REACH3 Analysis: Patient-Reported cGVHD Improvement Correlated With Overall Response, TSS Response

Patient-reported responses in chronic graft-versus-host disease (cGVHD) improvement are associated with overall response, total symptom score (TSS) response, and failure-free survival (FFS), according to an analysis of the phase III REACH3 trial.

The results were presented by Joseph Pidala, MD, PhD, of the H. Lee Moffitt Cancer Center, at the 2025 Tandem Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR.

Using prospective data from the REACH3 trial of ruxolitinib versus best available therapy for cGVHD, the researchers assessed correlations of patient-reported response with National Institutes of Health overall response and TSS response at six months. Using the Patient Global Impression of Change (PGIC), 160 patients rated their cGVHD as either improved (a little better to very much better) or not improved (no change to very much worse) at six months. The researchers assessed overall survival (OS), FFS, TSS response (defined as at least a 7-point reduction in cGVHD TSS), and overall response, including complete and partial response.

Of the 120 (75.0%) patients who reported cGVHD improvement, 88.1% received ruxolitinib and 60.5% received best available therapy. Of the 40 (25.0%) patients who reported no improvement, 11.9% received ruxolitinib and 39.5% received best available therapy.

Of the 97 patients who achieved an overall response, 86 (88.7%) reported cGVHD improvement and 11 reported no improvement (11.3%). Of the 63 (39.4%) patients who did not achieve an overall response, 34 (54.0%) reported cGVHD improvement and 29 (46.0%) reported no improvement. According to Κappa (κ) and positive/negative percent agreement (PPA/NPA), there was fair agreement between overall response and PGIC (κ=0.37; PPA=0.89; NPA=0.46).

Fifty-four patients (33.8%) had a TSS response. Of those, 47 (87.0%) reported cGVHD improvement, and 7 (13.0%) reported no improvement. Among the 106 (66.3%) patients who did not have a TSS response, 73 (68.9%) reported cGVHD improvement and 33 (31.1%) reported no improvement. Kappa showed minimal  agreement between TSS and PGIC (κ =0.14; PPA=0.87; NPA=0.31).

The researchers also noted a significantly longer median FFS among the overall population for patients who reported cGVHD improvement compared with those who reported no improvement (32.9 vs 0.92 months, P=0.002). There was no difference in OS, and the median FFS was not evaluable in either PGIC subgroup for ruxolitinib (P=0.18).

“The findings continue to support that this outcome captures a unique dimension of clinical benefit and that 6-month patient-reported response is associated with subsequent FFS,” Dr. Pidala and colleagues concluded.

Reference

Im A, Kintsch E, Xue Z, et al. Patient-reported response captures unique dimension of clinical benefit in chronic graft-versus-host disease (cGVHD): an analysis from the ruxolitinib versus best available therapy REACH3 trial. Abstract #187. Presented at the 2025 Tandem Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR; February 12-15, 2025; Honolulu, Hawai’i.