Jakafi Is the First and Only FDA-Approved Treatment for Patients With Steroid-Refractory aGVHD1
JAKAFI WAS EVALUATED IN BOTH PHASE 2 AND PHASE 3 CLINICAL STUDIES1-3
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; 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.
aPatients had Grade II to IV aGVHD, as defined according to MAGIC criteria, that 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
At Day 28, 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; 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 in both the Grade III or IV aGVHD groups responded.1
ORR, overall response rate.
Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.
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 acute GVHD, death, or worsening in any organ by one stage compared to 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 acute GVHD, 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.
aProgression was defined as worsening by 1 stage in any organ without improvement in other organs in comparison to prior response assessment.
bIncrease from baseline dose.
- 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.