Until recently, steroid-refractory acute GvHD has been really a nightmare when it comes to developing new drugs, and many trials have failed, unfortunately. The REACH2 trial actually was the first successful Phase III randomized trial in the field of steroid-refractory acute GvHD. This is a large trial. It has been already published, so you can see all the details in the paper. But the key message, if you look to the overall response rate at day 28, which is usually the endpoint that’s well accepted for this kind of study, actually there is a clear benefit for using ruxolitinib, which was tested in this REACH2 trial and randomized against the so-called best available therapy...
Until recently, steroid-refractory acute GvHD has been really a nightmare when it comes to developing new drugs, and many trials have failed, unfortunately. The REACH2 trial actually was the first successful Phase III randomized trial in the field of steroid-refractory acute GvHD. This is a large trial. It has been already published, so you can see all the details in the paper. But the key message, if you look to the overall response rate at day 28, which is usually the endpoint that’s well accepted for this kind of study, actually there is a clear benefit for using ruxolitinib, which was tested in this REACH2 trial and randomized against the so-called best available therapy. There was a clear superiority in favor of ruxolitinib compared to best available therapy whether you consider the response rate at day 28, but also at day 56 in terms of durability. But also, it is important to emphasize that the failure-free survival was because when it comes to transplant, you have to factor in different parameters, especially the problem of relapse. And actually, when it comes to failure-free survival, the results were also in favor of ruxolitinib. And this actually led, in addition to the results of the REACH1 trial which was before the REACH2 trial, to the approval by the FDA of ruxolitinib in steroid-refractory acute GVHD. So I think this REACH2 trial has been a really important trial in the acute GvHD space.
