Managing High-Risk NMIBC
Transcript: Neal Shore on nadofaragene firadenovec
Dr. Neal Shore
Interview recorded February 2025. All transcripts are created from interview footage and directly reflect the content of the interview at the time. The content is that of the speaker and is not adjusted by Medthority.
I was very involved in the clinical trial development of nadofaragene firadenovec with the SUO Clinical Trials Consortium. Great organisation. Involved in the phase two and the phase three, which led to its approval. And that was in a high-risk NMIBC BCG-unresponsive patients, ultimately with CIS and high-grade papillary disease. We're now looking... And that's now commercially available in the US, and I believe, pending some additional approvals in countries outside the US. But now we're looking at, there was a nice presentation that was done looking at some real-world outcomes, and, you know, it actually looked better. Their clinical response rates at three and six months were even better than what we had reported in our JCO and The Lancet Oncology publications. So that was nice to see that. Small numbers, but nonetheless positive reports. And in our ABLE-32, this is a randomised controlled phase 3B of nadofaragene firadenovec versus observation in patients with intermediate-risk NMIBC. You know, that disease population or that stage, the intermediate-risk is a little, you know, you know, we, you know, we've given BCG in the past.
That's a challenge maybe with the BCG shortage for prioritising who gets a BCG specifically for the high-risk. But we have some of our intermediate-risk patients who really are plagued by a high degree of recurrence and repetitive TURBTs. And so I think this will be a good study to see if this can cut down on recurrence versus an observation arm. That's really the gist of it. And it's, as I said, it's a phase 3B study being conducted globally.
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