The SENTRY trial is a Phase III pivotal trial of selinexor and ruxolitinib versus placebo and ruxolitinib. It was done in patients with JAK inhibitor naive myelofibrosis with DIPSS score of intermediate one, two or high. Platelets have to be 100,000 or higher. So this trial, you know, is one of several in the field that have explored a synergistic combination on a ruxolitinib backbone and compared it to ruxolitinib and placebo...
The SENTRY trial is a Phase III pivotal trial of selinexor and ruxolitinib versus placebo and ruxolitinib. It was done in patients with JAK inhibitor naive myelofibrosis with DIPSS score of intermediate one, two or high. Platelets have to be 100,000 or higher. So this trial, you know, is one of several in the field that have explored a synergistic combination on a ruxolitinib backbone and compared it to ruxolitinib and placebo. But there are a couple of things that really distinguish the SENTRY trial. Now, first, let me start by saying that the co-primary endpoint of spleen volume reduction of 35% or more, what we call SVR35, was easily met. It was about 50% in the combination arm and 28% in the RUX arm at 24 weeks. However, the other co-primary endpoint of total symptom score reduction, you know, absolute reduction in the mean TSS was actually not met. So that was about the same in both arms. Okay. So there was not a difference is what I mean. It went down in both arms, but there wasn’t a difference. However, there was a survival benefit, which was really unexpected and very early. Like around median 11 months of follow-up, we saw this survival benefit for the combination with a hazard ratio of 0.43 and a p-value of 0.0222. So this is, you know, a robust, you know, statistically, you know, in statistical terms, a robust difference. So this is very promising, and the trial is being kept blinded. The patients are being followed so that we can further understand this survival benefit and see if it, you know, continues, et cetera. So look forward to the 48-week results, for example, at ASH. And then the other point is that, you know, there were VAF reductions, although that’s been shown with other synergistic combinations as well, but driver mutation VAF reductions, I mean. But I think what really stands out is this survival aspect. And also importantly, in both arms, the survival correlated with spleen. So spleen reduction gave you better survival in both arms, which is something we know. It was nice to see that we recapitulated. You know, we already know that from RUX, where the deeper the spleen responds, the better the survival. And that correlation was also seen here.
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