Jakafi Is the First and Only FDA-Approved Treatment for Patients With Steroid-Refractory aGVHD1,2
FDA approval for Jakafi for the treatments of SR aGVHD was based on the data from the REACH1 study.
aGVHD, acute graft-versus-host disease; BID, twice daily; GVHD, graft-versus-host disease; FDA, Food and Drug Administration; MAGIC, Mount Sinai Acute GVHD International Consortium; ORR, overall response rate; REACH, Ruxolitinib in PatiEnts with RefrACtory Graft-Versus-Host Disease After Allogeneic Stem Cell Transplantation; SR, steroid refractory.
aPatients had grades II to IV aGVHD, as defined according to MAGIC criteria, which occurred after allogeneic hematopoietic stem cell transplant.1
bTwenty-two patients were not included in the efficacy analysis because they received 2 or more prior anti-GVHD therapies (n = 12) or did not receive an adequate dose of corticosteroids (n = 10). All 71 patients were included in the safety analysis.1,2
REACH1
At Day 28, the Majority of Evaluable Patients in the Phase 2 REACH1 Study Responded
Responses were achieved at day 28 for the majority of patients in REACH1.1
More than half of the patients who responded by day 28 (54%; 15 of 28 patients) achieved a complete response.1
CR, complete response; ORR, overall response rate; PR, partial response; REACH, Ruxolitinib in PatiEnts with RefrACtory Graft-Versus-Host Disease After Allogeneic Stem Cell Transplantation;
VGPR, very good partial response.
aDefined as the proportion of patients who had a CR, VGPR, or PR at day 28, based on the Center for International Blood and Marrow Transplant Research definitions.1
Responses With Jakafi by Day 28 Across All Grades Studied
In a subgroup analysis of overall response rate at day 28, all 13 patients with grade II acute GVHD (aGVHD) at baseline responded to treatment with Jakafi, and over 40% of patients responded in each of the grade III and grade IV aGVHD groups.1
aGVHD, acute graft-versus-host disease; ORR, overall response rate.
Responses With Jakafi by Day 28 Affecting All Organs
In a subgroup analysis of overall response rate at day 28, responses with Jakafi were seen across all affected organs.3
CI, confidence interval; GI, gastrointestinal; ORR, overall response rate.
REACH1: Median Duration of Response (Key Secondary Endpoint) for Day 28 Responders
The median duration of response in REACH1 for patients who responded by day 28 was calculated using 2 measures, each with a different definition of disease progression1:
- METHOD 1) Calculated from day 28 until need for new therapy for aGVHD, death, or worsening in any organ by one stage compared with prior response assessment (disease progression)
For this measure, the median duration of response was 16 days (95% CI: 9, 83)
- METHOD 2) Calculated from day 28 until need for new therapy for aGVHD, death, or increase in steroid dose from baseline (disease progression)
For this measure, the median duration of response was 173 days (95% CI: 66, NE)
DOR, duration of response; NE, not evaluable; REACH, Ruxolitinib in PatiEnts with RefrACtory Graft-Versus-Host Disease After Allogeneic Stem Cell Transplantation.
a Progression was defined as worsening by 1 stage in any organ without improvement in other organs compared with prior response assessment.
b Increase from baseline dose.
References
- Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.
- Jagasia M, Perales MA, Schroeder MA, et al. Ruxolitinib for the treatment of steroid-refractory acute GVHD (REACH1): a multicenter, open-label phase 2 trial. Blood. 2020;135(20):1739-1749.
- Data on file. Incyte Corporation. Wilmington, DE.
