Drs Cheryl Lee and Karim Chamie talk about efforts to develop nogapendekin alfa, aka N-803, and where it may fit into the shifting treatment paradigm for non–muscle-invasive bladder cancer.
. We used very similar definitions as far as inclusion criteria: Patients must have been BCG-unresponsive, meaning that they must have received adequate doses of BCG — at least five of six induction courses and at least two of three maintenance doses. Some patients were deemed BCG-unresponsive if they progressed to high-grade T1 despite just an induction course, and they must have recurred or been refractory within a year. That's the definition with which we work.
What we found was that most of the complete responses occurred after the induction course. About 55% of patients who received an induction course had a complete response. But that meant that 45% of the people didn't, so they failed the study. What we did was give some of those patients a second shot of an induction course. We found we were able to get an additional 16% of patients to have a complete response.
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