Novel Treatment Strategies in Muscle Invasive Bladder Cancer

Transcript:
Shilpa Gupta, MD: Now we’ll switch gears to what is new in the localized bladder cancer space. I’ll start with Andrea. Last year, Andrea, at ASCO GU [American Society of Clinical Oncology Genitourinary Cancers Symposium] 2022, we saw Daniel Petrylak MD, Yale School of Medicine, New Haven, CT, present the EV-103 Cohort H data. Could you walk us through that and how you found that exciting, if at all, and what are you looking forward to?

Andrea B. Apolo, MD: We have data in the metastatic setting that enfortumab vedotin [Padcev] is active. It’s active on its own as monotherapy and it’s active in combination with a checkpoint inhibitor, pembrolizumab [Keytruda]. So last year we saw cohort H presented and this was enfortumab vedotin given in the neoadjuvant setting and we saw it as monotherapy. We saw a pathologic complete response of 36%, so I think that was exciting. This year, we saw several trials in progress that are asking the question about enfortumab vedotin alone or enfortumab vedotin in combination with pembrolizumab.

We have the EV-303 study which is neoadjuvant pembrolizumab alone or pembrolizumab plus enfortumab vedotin, and then we have the randomized phase 3 trial, the EV-304 study, of enfortumab vedotin plus pembrolizumab randomized vs. platinum-based chemotherapy in the neoadjuvant setting for patients with muscle-invasive disease. I think that it’s going to be very interesting to move these therapies forward and to see what the outcomes are in these trials.

Shilpa Gupta, MD: It’s really an interesting era to be in where we are thinking if the platinum will go away in the future and how that might affect our neoadjuvant space. Mamta, in terms of innovation and devices, we’ve heard a lot about TAR-200 and how they are incorporating it in the muscle-invasive space. Would you like to just give a brief overview and what you think is novel about this?

Mamta Parikh, MD, MS: TAR-200 is an interesting intravesical form of gemcitabine, but it’s being used in interesting ways now in clinical trials. There’s the SunRISe program, which has several different trials ongoing. SunRISe-1 is in BCG [Bacillus Calmette-Guerin] unresponsive high-risk non—muscle-invasive bladder cancer. It’s a phase 2B study that’s looking at TAR-200 plus cetrelimab or TAR-200 alone or cetrelimab alone. That will give us information about the non—muscle-invasive space.

Interestingly, there’s also a phase 3 trial going on in the muscle-invasive bladder cancer space looking at TAR-200 plus cetrelimab vs. chemotherapy plus radiation. So, this again is another potential bladder-sparing approach and it’s a novel approach to treating muscle-invasive bladder cancer. We don’t usually incorporate intravesical treatment into that space so that will be a really interesting area. SunRISe-3 is again looking at the non—muscle-invasive bladder cancer space. This is a phase 3 trial that’s looking at TAR-200 plus cetrelimab or TAR-200 alone vs. BCG itself. So going after the big guns. There would be a lot of interesting data coming out of the SunRISe program, I think.

Transcript edited for clarity.