Urology Times的动态

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Since NATO Ferragine Danovic was approved in December 2022, there hasn't been any published real world data. And since of course real world outcomes and clinical trial outcomes can vary at times due to the screening criteria and differences between a clinical trial population and a real world population, we conducted a real world evaluation of patients treated with nanofarad gene Ferdina VEC at all. 3 Mayo Clinic sites in Arizona, Rochester and Florida and we looked at patients from the first dose given outside of a clinical trial in November 2023 up through December of 2024 before we. Put the data together and all of our patients were met. FDA defined BCG unresponsive criteria for non muscle invasive bladder cancer. There were 46 patients treated during this time frame and of those 46 patients three had pending post treatment cystoscopy. So while all 46 were evaluated for safety outcomes 43 or efficacy evaluable. Of those 43 patients, 24 had carcinoma insight 2 with or without papillary disease at three months. Those patients had a 79% CR rate, complete response rate which was durable in 74% at six months and 60% at 9:00. That's in the papillary only cohort which had 19 patients, high grade recurrence free survival was 68% at three months, which was durable at 57% at six months and 40% at nine months. And in terms of safety? 100% overall survival at median follow-up of eight about 8 months. But what we did see was a lot of low grade transient and local side effects usually during treatment which resolved and less commonly. We had 9% with grade 3 adverse events which included fatigue, fever and dizziness, but generally. The safety profile was in line with the clinical trial, which was low grade and tolerable, although frequent. Yeah. And I would just add that. The three and six months KM estimates are in the intention to treat population and not in the complete response population. So it wouldn't be 74% of 79% that responded it. It would be 74% of the intention to create complete intention to treat population was incomplete response at six months and then 60% at nine months. Thanks for clarifying that. Yeah. And in fact within the 79% with of CIS patients with complete response at three months, 84% of those patients remained in complete response at the end of our eight months of follow up.