Steven H. Stein
Executive Vice President & Chief Medical Officer at Incyte
Matt, it's Steven. Thank you for your questions. So just for everybody else, POD1UM-304 is our IV checkpoint retifanlimab in non-small cell lung cancer. It's a replication, if you will, love the initial pembro approval in that indication in that it's combination with chemotherapy versus checkpoint inhibitor alone. And as you point out, it's a global study with sites all over the world, including in the United States. So, we think that is the central difference from the Lilly issue they had with their checkpoint inhibitor where it was China-only data. So, we have representation across Western Europe, Eastern Europe, Asia and a small amount of U.S. sites. So, we think from a diversity of subject point of view, we're well covered with that.
The modeling of the study is exactly from a statistical point of view, in keeping with what we're seeing in the initial pembro approval in that indication, that was discussed with regulators and feedback was given and aligned with them. So, we feel we are in a completely different position to what was the central complaint against the Lilly submission with their checkpoint inhibitor in non-small cell lung cancer, given the diversity of our population across the world, the size of the study, replication of the statistics to achieve the same end points, which again, wasn't exactly the case with the ODAC you referenced.
For tafasitamab in combination with parsaclisib, we remain interested despite some of the negative halo on PI3 delta inhibitors for a number of reasons. Firstly, because -- we know this is a tremendously active doublet from work that MorphoSys have done before with tafasitamab with idelalisib in that having upwards of 100% response rates. So we are absolutely continuing to look at our data in topMIND, which is ongoing across different disease segments, including lymphoma, including chronic lymphocytic leukemia. But you are right, I mean, there is a large increase in the safety of delta inhibitors, and it's something we'll have to consider very carefully before going forward with any bigger study there. We hope in the second half of this year to have decent datasets for the different subgroups of diffuse large B-cell lymphoma, low-grade lymphomas, chronic lymphocytic leukemia with that doublet and then we'll have to make decisions in keeping with the context you allude to.
I'm glad you also brought up the myelofibrosis program because, again, it's RUX in combination with parsaclisib in two different settings. So there's a first line study, which is enrolling very well. It's a goal enrollment of around 440 patients, and it's a very clean study in that it's RUX plus parsaclisib versus RUX alone in that indication with the SVR 35% decrease primary endpoint. So the differences again, given the milieu, you talk about the PI3 delta inhibitors, is that, this is a randomized study at a different dose of a delta inhibitor. There's no induction therapy, it's a standard constant dose. It's a defined treatment period. The studies were agreed to and signed off with regulatory authorities and does has -- as you point out, also the ability to capture overall survival. So we think we're well covered in that indication. The suboptimal study there is in about 220 patients also enrolling very well. Should complete next year, different endpoints, again, a randomized study and in capture, a primary endpoint, as well as secondary endpoints that will include safety. So, again, a different dose, and we think we're well covered there as well. But we're not immune to the fact that the road for delta inhibitors will be extremely safety focused as they should be. Thanks.