General Updates | Ongoing clinical trials to watch in ITP

So, you know, the BAFF receptor inhibitor ianalumab is certainly one that comes to mind. Ianalumab is an agent that was shown in the VAYHIT3 study, as previously presented at medical congresses, to be effective in treatment of patients with third line and later ITP, and there are two large phase three studies of ianalumab to discuss. The VAYHIT2 study, which is evaluating ianalumab plus eltrombopag or placebo plus eltrombopag in patients with true second line ITP after failure of steroids. And that study completed, and there was a top-line press release demonstrating that study was a positive study. And then there’s the VAYHIT1 study, which is similar to VAYHIT2 except in true first-line ITP, and ianalumab or placebo is given in combination with corticosteroids. So this is a huge development program for a drug in ITP, and I think really promising not just for the treatment of kind of later-line patients, as VAYHIT3 has shown us, but also potentially as a disease-modifying drug earlier in the course of disease as VAYHIT2 and VAYHIT1 could very well show us, and so I think that that is a different way of treating ITP and incorporating combination therapy. 

Unfortunately, the subcutaneous phase three study of efgartigimod was not a positive study, but there is now another phase three study called ADVANCE-Next. That is ongoing with IV efgartigimod in ITP, and that could also represent a treatment option with a lot of promise, given that it affects the neonatal Fc receptor, which is responsible for the physiologic half-life of IgG, and knocking down that receptor will help get rid of the platelet autoantibodies that are troublesome. 

There’s a few other therapies to talk about. There’s povetacicept,, which is a BAFF-APRIL antagonist. That is currently in a basket study in ITP. There are anti-CD38 monoclonal antibodies, particularly mezagitimab. And mezagitimab just had a very nice positive phase two study that was presented. And this drug had very high response rates, even in very relapsed/refractory patients, and it targets those long-lived plasma cells that we know cause so much trouble in this disease. So, you know, I think that there are a lot of really promising drugs on the horizon for ITP. And we’re at the beginning of that sort of third phase, third era of ITP treatment, which is really going to be focused more on these targeted therapies. 

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