So this is the final analysis of the first in human Phase I study of the erda-iDRS which is an intravesical drug releasing system releasing erdafitinib for a period of three months into the bladder which is essentially a local erdafitinib. And we’re changing the device every three months for a period of one year. So the patient was under the same urine concentration of erdafitinib for one whole year...
So this is the final analysis of the first in human Phase I study of the erda-iDRS which is an intravesical drug releasing system releasing erdafitinib for a period of three months into the bladder which is essentially a local erdafitinib. And we’re changing the device every three months for a period of one year. So the patient was under the same urine concentration of erdafitinib for one whole year. In this phase one study, of course, we are looking at safety of the device, which it’s absolutely well tolerated. It had only some low-grade urinary tract symptoms mainly dysuria and some hematuria mainly. There were no systemic toxicities associated with oral erdafitinib like retinal toxicities or hyperphosphatemia which is one of the most advantageous things of this new releasing system into the bladder, and very few discontinuations because of adverse events. We were analyzing two different cohorts of patients. One is a high-risk NMIBC, so patients with BCG exposed, relapsed of the disease. We were doing a complete TURBT before starting the treatment, so it was like an adjuvant treatment after the TURBT. And with that, we saw that at one year, at 12 months, we had a disease-free survival that was of 83%. So a huge percentage of patients were free of disease at one year, with the median duration of the response of 20 months in a follow-up of 24 months. Then we have the other group of patients, the cohort three that was presented, which is intermediate-risk NMIBC. That means patients with history of only low-grade tumors, that they had a recurrence, and we were giving this new treatment as an adjuvant therapy. Actually, unresected tumors were necessary before starting the treatment. And with that, we see that at six months of treatment, 89% of the patients had a complete response into their bladder, with a median duration of the response of 18 months at a follow-up of 18 months. So the preliminary oncological results are also very good and promising.
