Drs Cheryl Lee and SBoorjian share detailed insights about a model drug development partnership involving the first-in-class therapy for BCG-unresponsive non–muscle-invasive bladdercancer. MedTwitter
, open-label, randomized study of two different doses was conducted. The phase 2 study showed that 35% of patients were high-grade recurrence-free at 12 months after treatment. Those were generally patients who had received considerable amounts of BCG., and this study was done in partnership with the FDA as well as with direct guidance from the FDA in terms of how the trial was designed.
Certainly, many groups are delivering systemic therapy to their patients, but it has a different workflow. Having an intravesical agent is ideal. Hopefully that reduces some of the systemic side effects that may be appreciated. Can you talk about the schedule of delivery of the agent? I don't know if we had a chance to touch base on that, because I think that is also something favorable.I think it's particularly favorable both for clinicians and for patients.
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