So the Primo study um with a a single agent study of Duvali, the oral PI 3 kinase inhibitor against the gamma-delta isoforms, um. As a single arm phase two study in peripheral T cell lymphomas, and uh there were 123 patients enrolled to primo internationally. Um, the beginning of the study included a dose um finding determination study where they compared or they had patients who went on 25 mg BID of Duvollicid versus 75 mg BID and in the lower dose, it was seen that more patients actually came off the study early. For um adverse events that were related to progression, suggesting that um getting the higher dose early on for disease control seemed to be a beneficial strategy, um, but that was really evaluated during that dose finding portion. That led to the expansion dose that was taken forward in primal to be 75 mg BID for two cycles, followed by 25 mg BID subsequently for intolerance or progression. And what was seen in Primo was that the overall response rate to Dubili was 48% with a complete remission rate of 33%, um, and, um, when you look at all comers, the response rate was higher in the patients who had AITL. So in the patients who had AITL, which is the TFH phenotype neoplasm, the overall response was 62%, and the median duration of response was. 8 months in that population. In anaplastic large cell lymphoma, in contrast, it was seen that the response rate was only 15% with very limited durability, only like a month and a half, and for patients with peripheral T cell lymphoma, not otherwise specified, the response rate was also about 50%. Um, with the duration of response being about, uh, just shy of 4 months. And so, um, it looks like Dubiliid is active in, uh, PTCL NOS and AITL but seems based on the primo trial to be particularly um lead to higher rates of. Response in uh AITL but also shows uh effectiveness in patients with peripheral T cell lymphoma NOS. The data from um Primo has led to the T Turzo study which is being which is now enrolling uh primarily in Europe, um. Where patients who have TFH phenotype lymphomas are randomized to Duvaliib or standard of care, which could be either gym cytidine or bendamustine. Um, and so we hope that that will help to demonstrate our experience with Duvaliid so far, um, where we've seen the. Response rates being uh 50% or higher in the um in the TFH phenotype patients, um, which is in contrast to our currently available agents at least in the United States, which have response rates of 25% to 30% overall.
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