LUGPA Bladder Cancer Highlights: Key Trials and Trends for 2025

Sia Daneshmand, MD, of Keck Medicine of USC, talks about the biggest developments and key highlights in bladder cancer from the LUGPA 2024 Annual Meeting, including the recent approval of ANKTIVA and the SunRISe-1 study of the TAR-200 drug delivery system for BCG-unresponsive high-risk non-muscle-invasive bladder cancer.

Transcript 

What are you most looking forward to at LUGPA, especially regarding updates in the bladder cancer space? 

Dr. Sia Daneshmand: Yeah, so there’s a lot happening in bladder right now. It’s a good time for bladder cancer researchers and patients alike. There are several trials that are reporting their outcomes. We have some that are published. We have new available therapies there.

So there’s a lot happening over the past year. So just a couple of highlights this year. Adstiladrin was approved late last year in November and became commercially available at the beginning of this year. So that is in our hands right now. We’re using it. Patients are benefiting. It’s very, very well tolerated. This is nadofaragene firadenovec or Adstiladrin. It’s placed in the bladder once every three months, so it’s a very, very convenient treatment option for BCG refractory disease. So that’s one. Anktiva was recently approved. This is the IL15 super-agonist, and that’s given along with BCG. We’re seeing very high CR rates based on their pivotal trial, and that got FDA approval. Again, is commercially available.

One of the challenges there, it’s in combination with BCG and of course we have a shortage of BCG, and so it’s a little bit challenging right now, but they’re working on some solutions. But that is commercially available. And again, very effective treatment regimen for BCG unresponsive disease.

So those are two commercially available agents that were approved this year. There are multiple other ones in clinical trials. One of the most exciting ones is the TAR-200 device that’s being investigated in multiple different trials, called the SunRISe studies. We have SunRISe 1 through 5, and SunRISe-1 is the one that was in BCG-refractory disease. And the results have been presented at multiple different meetings throughout the year, and each time we’re seeing better and better results as more and more patients are enrolled and have a longer follow-up. So with the SunRISe-1 study for BCG-unresponsive disease in cohort two, which is the device alone, the TAR-200, sorry, is the device that’s placed in the bladder.

It’s sort of shaped like a pretzel and it’s a drug-eluting system. So it’s a sustained release of gemcitabine in the bladder, is placed once every three weeks for the first 24 weeks and removed via a cystoscopy and a grasper. Very easy, very well tolerated. And we’re seeing CR rates in the 80 to 85% range so far. And obviously there’s ongoing follow up, but these are very, very high response rates.

But these newer agents, and then we have the cretostimogene grenadenorepvec that’s also in clinical trials right now. We have the BOND-003 study showing, again, very high response rates in the 80% range for these patients at any time. There’s ongoing responses more than one year, two years, and three years, even for those patients.

So both of these last ones that I mentioned have FDA fast-track approval. And so we’re hoping that in the next year or so we’ll be seeing these commercially available and expand again that armamentarium of treatment options available for these patients who have failed multiple different previous treatments.

One of the other exciting trials is the BCG-naive space. In the past, there have been reluctance to get into this space, given the highly efficacious results of BCG, but there are a number of trials that will be reporting soon on the addition of PD-1 or PD-L1 immune checkpoint inhibitors to BCG to see if we can improve the results of BCG.

And then there are some drugs that are going head-to-head. The TAR-200 device that I told you about earlier is going head-to-head with BCG in Sunrise Three, the study that will compare directly BCG versus cetrelimab, which is a PD-1 inhibitor plus the TAR-200 device, seeing if we can achieve better initial response rates in BCG-naive patients. That trial accrued very well globally with over 1000 patients. And we’re waiting to see the results, which again, hopefully we’ll see some results coming in early next year.

And the last one I want to mention is probably the enGene trial. We have some novel mechanisms of therapy in the enGene trial that will be, that’s in phase two studies right now, and we’ll probably see more results coming out from that trial.

So lots happening in bladder. I think the takeaway is we have two new drugs available and watch out for the further results on the sunrise studies and the cretostimogene studies from CG Oncology. So, exciting times.