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Subgroup analysis of ruxolitinib in patients with steroid-refractory acute GvHD – update from EHA 2020

Jun 17, 2020
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The main results of the phase III REACH2 trial (NCT02913261), comparing the efficacy and safety of ruxolitinib (RUX) with nine best available therapies (BAT) in patients with steroid-refractory acute graft-versus-host-disease (SR-aGvHD), were published in The New England Journal of Medicine. The study, which was recently summarized on the GvHD Hub, demonstrated significantly improved outcomes in patients treated with RUX compared with BAT.

During the European Hematology Association (EHA) virtual meeting, Robert Zeiser from the University Hospital Freiburg, DE, presented a follow-up analysis of the REACH2 study, which examined responses in different subgroups of patients of the trial. The previously published Day-28 response rate for the overall population was 62.3% with RUX vs 39.4% with BAT (odds ratio [OR] 2.64; p < 0.001). The subsequent analysis of response by baseline characteristics revealed superior efficacy of RUX vs BAT in several subgroups of patients, including those aged 18–65 years. RUX showed better responses irrespective of the severity of aGvHD, organ involvement, donor type, and type of prior conditioning regiment, and prior GvHD therapy used (Table 1).

Table 1. Subgroups with higher overall response rates at Day-28 for RUX vs BAT

aGvHD, acute graft-versus-host disease; CNI, calcineurin inhibitors; GI, gastrointestinal; SR, steroid-refractory

Subgroup

ORR, %

RUX

BAT

Age group

 

 

16-65 years

64.8

38.1

Gender

 

 

Female

62.9

39.1

Male

62.0

39.6

Conditioning regimen

 

 

Myeloablative

55.3

36.9

Non-myeloablative

71.0

41.5

Reduced-intensity

71.1

40.8

Donor source/ HLA match status

 

 

Not related and match

61.5

40.3

Not related and mismatch

71.1

44.4

Related and match

59.3

24.1

aGvHD grade at randomization

 

 

Grade II

75.5

50.9

Grade III

56.3

37.5

Grade IV

53.3

23.3

Organ involvement

 

 

Liver

44.4

19.2

Lower GI

57.34

33.0

Skin

72.0

47.3

Upper GI

67.9

37.8

Donor type

 

 

Not related

64.8

41.0

Related

57.1

36.4

Criteria for SR-aGvHD

 

 

Failure on steroid taper

66.0

46.9

Failure to achieve a response after 7 days

56.9

38.1

Progression after ≥ 3 days

66.6

32.6

Prior aGvHD therapy

 

 

Steroid + CNI

62.3

40.8

Steroid + CNI + other systemic aGvHD treatment

66.1

38.8

Furthermore, RUX induced higher rates of response at Day 28, which were maintained at Day 56, than BAT (39.6% vs 21.9%; p < 0.001). The cumulative incidence of loss of response at 6 months for RUX and BAT were 9.65% (95% CI, 4.39–17.4) and 39.96 (95% CI, 25.54–52.19), respectively. The safety profile was consistent with that previously reported. There were no new or unexpected safety concerns.

  1. Zeiser R, von Bubnoff N, Niederwieser D, et al. Ruxolitinib versus best available therapy in patients with steroid-refractory acute graft-versus-host disease: overall response rate by baseline characteristics in the randomized phase 3 REACH2 trial. Oral abstract #S255. 2020 EHA Annual Meeting; Jun 12, 2020; Virtual.

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