To further discuss the artistry 7 trial, uh, the primary endpoint for this trial was overall survival. Uh, the assumption was that a median overall survival for 10 months for the control arm of chemotherapy alone, uh, and a presumed median overall survival of 14.3 months for the combination therapy nimbaleukin and pembrolizumab, which is the comparator arm. So, again, we'll talk a little bit about the dosing schedule. So arm one in the combination, you're giving them veleukin, days 1 through 5 is an IV infusion, and you're given pembrolizumab on day one. This is done on a 3 week cycle, which is the standard cycle for pembrolizumab dosing. Uh, the two individual uh agent arms with both pembrolizumab and Maleukin are the same as they would be in the combination, but you're done with a single drug. And all of the dosing schedules for the standard of care chemotherapies are as they would have been approved, uh, based on prior trials. Uh, the standard of care chemotherapies used in this case were uh pegated liposome doxorubicin, Paclitaxel, topatikin, or temcitabine. We did have a number of uh planned subgroup analysis uh based on this trial, including, as this was a global registration trial where patients were enrolled, uh, North America and Europe versus the rest of the world, also age and also race, as ways of looking at at possible discrepancies and treatment benefit amongst the patients. We also were looking at uh biomarkers within the patients. Historical biopsy samples, including a PDL1 score, and patients will be analyzed based on a CPS score of less than 10 or greater than 10. We're also looking at location of disease. Did patients have visceral metastasis versus non-visceral metastasis. Uh, the patients have ascites uh at the time of screening for trial? Uh, there are a number of baseline characteristics that, uh, we're also looking at, some of which are stratification factors including Uh, the disease stage of primary diagnosis, in other words, was a patient of stage 1 to 3 versus a stage 4, performance status prior PARP inhibitor usage, the number of lines of prior therapy, uh, to be included, the patients had to have had between, uh, or less than 5 lines of chemotherapy to be enrolled on this trial, uh, in the platinum resistant setting. Uh, stratification factors included, include PDL1 score, as well as the investigators choice of chemotherapy. Uh, in the, uh, control arm, uh, we understand that Paclitaxel will likely be the most commonly chosen, uh, agent, and so there's a stratification factor on Paclitaxel versus others within the roll control arm. Uh, we also are going to stratify based on histology of the, the, the tumor. In other words, is the tumor high grade serious versus it is it another uh type of epithelial ovarian cancer, including endometrioid clear cell, or others that were allowed to be enrolled in the trial.
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