REACH1 and REACH2 Studies – Patients With Steroid-Refractory aGVHD Treated with Jakafi

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 STUDIES^1-3

FDA approval for Jakafi for the treatment of steroid-refractory aGVHD was based on the data from the REACH1 study.

Chart showing REACH1 Study Design & REACH2 Study Design Phase 3 Study

REACH2 data are not included in the Jakafi Prescribing Information.

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
^cThe REACH2 study was conducted in 105 centers across 22 countries.³
^dCrossover from control therapy to Jakafi therapy was permitted if patients did not have a response at Day 28 or if they had a loss of response thereafter and received additional systemic therapy, and they did not have signs of chronic GVHD.³
^eControl therapy was chosen by the investigator at the time of randomization (antithymocyte globulin, extracorporeal photopheresis, mesenchymal stromal cells, low-dose methotrexate, mycophenolate mofetil, everolimus, sirolimus, etanercept, or infliximab).³

REACH1

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

Image of a chart showing REACH1: ORR at Day 28 (Primary Endpoint)

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 Affecting All Organs

In a subgroup analysis of overall response rate at day 28, responses with Jakafi were seen across all affected organs.⁴

Image of a chart showing subgroup analysis of overall response rate at day 28

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)

Image of a chart showing Duration of response (DOR) assessment

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.

REACH2

FDA approval for Jakafi for the treatment of steroid-refractory aGVHD was based on the data from the REACH1 study. REACH2 data are not included in the Jakafi Prescribing Information. Although the adverse event data reported in REACH2 is informative, the risk information as described in the Full Prescribing Information for Jakafi should be considered when making prescribing decisions.

REACH2: For All Grades Studied, Overall Response Rates at Day 28 Were Higher With Jakafi Compared With Control Therapy³

In REACH2, 62.3% of patients treated with Jakafi achieved complete response (CR) or partial response (PR) compared with 39.4% of patients treated with control therapy (P <0.001; OR=2.64; 95% CI, 1.65-4.22).³

Image of a chart showing REACH2: ORR at Day 28 (Primary Endpoint)

CR, complete response; OR, odds ratio; ORR, overall response rate; PR, partial response.

^aDefined as the proportion of patients who had a CR or PR as compared with baseline organ staging without the use of additional systemic therapy for aGHVD.³

Response rates were higher with Jakafi across all grades and were highest in patients with Grade II aGVHD.

Image of a chart showing REACH2: ORR at Day 28 by aGVHD Grades (Subgroup Analysis)

aGVHD, acute graft-versus-host disease; CR, complete response; OR, odds ratio; ORR, overall response rate; PR, partial response.

For all affected organs, Jakafi demonstrated higher Day 28 overall responses vs control therapy⁴

REACH2 Subgroup Analysis: ORR at Day 28 by Organ Involvement at Baseline

aGVHD, acute graft-versus-host disease; CR, complete response; GI, gastrointestinal; OR, odds ratio; ORR, overall response rate; PR, partial response.

Significantly Higher Durable Overall Response Rate at Day 56 With Jakafi vs Control Therapy

REACH2: Durable Overall Response Rate at Day 56 (Key Secondary Endpoint) - ~2x patients achieved a durable overall response with Jakafi vs control therapy

CR, complete response; OR, odds ratio; PR, partial response.

^aDurable overall response was defined as the proportion of patients who had a response at Day 28 followed by CR or PR at Day 56.

Get REACH1 and REACH2 safety results.

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.
Zeiser R, von Bubnoff N, Butler J, et al. Ruxolitinib for glucocorticoid-refractory acute graft-versus-host disease. N Engl J Med. 2020;382(19):1800-1810.
Data on file. Incyte Corporation. Wilmington, DE.
Zeiser R, von Bubnoff N, Butler J, et al. Ruxolitinib for glucocorticoid-refractory acute graft-versus-host disease [supplementary appendix]. N Engl J Med. 2020;382(19):1800-1810.