Bladder Cancer: Guru Sonpavde, MD details STRONG study results presented at ASCO #GU21? that find fixed-dose durvalumab monotherapy safe in patients previously treated for urinary tract carcinoma. Abstract 429
So this is a large study, non randomized that looked at Del Valle mob in these patients, and the regimen was a little different than the, uh initially FDA approved regimen, which was 10 mg per kilo every two weeks in the initial approval. But what this study looked at is fixed dozing of development, given once every four weeks. And so in the fixed, dozing formulation of, uh, develop map, this was a large study giving 1500 mg of development intravenously every four weeks. The other unique thing about this large Phase two study, which accrued 867 patients, is that it allows patients who had even non euro material. Kostroma. Unlike the initial approvals, which are all in patients with a histology of your material or predominantly your material history allowed some non euro material carcinoma patients without any your material component. So the bottom line is that the study showed that this regiment was safe and active, and the activity is similar to the previous, uh, those that was initially if he approved the 10 mg particular every two weeks. So based on this study, basically fixed those development monotherapy every four weeks uh has been found to be an active and safe regimen in patients with metastatic curatorial carcinoma with progressive disease force, platinum based chemotherapy, and also just to emphasize that this dose is now FDA approved, in fact, for the therapy of these patients. So this is a nice compliment to the body of data we have with the rather map Second line checkpoint inhibitor therapy.
