Elizabeth Plimack: Welcome to UroToday. I'm Elizabeth Plimack. I'm a chief medical oncologist at Fox Chase Cancer Center in Philadelphia. I'm joined by Elena Sevillano Fernández at Clara Campal Cancer Center in Madrid. So Elena, thank you so much for joining us.

Elena Sevillano Fernández: Thank you, too.

Elizabeth Plimack: We brought you here to talk about a trials-in-progress poster that you're going to present tomorrow. So none of us have seen it, but very excited about the SASAN-SPARING trial. Tell us a little bit about it.

Elena Sevillano Fernández: So we know muscle-invasive bladder cancer is an aggressive disease. For decades, cisplatin-based and neoadjuvant chemotherapy has been the standard of care followed by radical cystectomy. We know this strategy saves lives, but it comes to an important cost to our patients-

Elizabeth Plimack: Right.

Elena Sevillano Fernández: ... not only in the urinary function, but also in the bowel, sexual, body image, and also quality of life. We are seeing that remarkably, some patients are responding quite well to neoadjuvant chemotherapy. So maybe we think that in this patient, we could maybe save their bladder. So the challenge in this situation is to identify which patient will be the perfect candidate to save their bladders safely. So SASAN-SPARING trial is trying to address this question. So how can we safely save this bladder without compromising their oncology outcomes?

Elizabeth Plimack: Right. So tell us a little bit about the design of the trial. I know there's a neoadjuvant component.

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: Then there's a bladder sparing piece and then what happens afterwards? Talk us through this.

Elena Sevillano Fernández: So SASAN-SPARING is a phase 2 trial. It's a multi-centers trial enrolling 70 patients with T2, T4, N0, M0 patients. So patient are eligible for cisplatin-based chemotherapy and radical cystectomy. So we apply four cycles of adjuvant cisplatin-based chemotherapy, and then we perform a comprehensive evaluation at risk staging with TURBT, MRI, a thorax scan, and also molecular analysis, not only of ctDNA, but also of utDNA and a microbiome profile.

Elizabeth Plimack: Fantastic.

Elena Sevillano Fernández: Yes. So every patient who has a clinical response, that is a clinical T0, T1 Ts or T1 goes to the maintenance arm and can maintain their bladder. So it's a bladder sparing strategy. And those patients responding, they can maintain with an immunotherapy strategy. And those patients who has not responders patient with a clinical T2 or greater, they go directly to radical cystectomy.

Elizabeth Plimack: Wonderful. So I have a couple questions.

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: In the neoadjuvant, what cisplatin-based chemotherapy did most patients get? Or are you using-

Elena Sevillano Fernández: Only cisplatin-based chemotherapy.

Elizabeth Plimack: Is it GemCis or...

Elena Sevillano Fernández: GemCis only. Yes.

Elizabeth Plimack: GemCis only. Okay.

Elena Sevillano Fernández: Yes. Yes.

Elizabeth Plimack: So GemCis and you did four cycles?

Elena Sevillano Fernández: Four cycles.

Elizabeth Plimack: You did four cycles.

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: And then this full assessment with all of the things, right?

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: I love that you're looking at imaging to make sure there's no metastases. You're looking at MRI maybe to look at thyroids.

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: You're doing that TURBT to do those blind biopsies to see.

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: So best you can tell that bladder's clean, then they keep it and then they get immunotherapy. Is that right, afterwards?

Elena Sevillano Fernández: Yes. After that, we maintain with sasanlimab. This is a subcutaneous immunotherapy. We apply one cycle every four weeks for 12 cycles. So we are making also a follow-up every 12 weeks with these different biomarkers, the molecular biomarkers and the image. And it's important to say that in every moment, if this patient we notice relapses, the patient are going to the cystectomy.

Elizabeth Plimack: Got it.

Elena Sevillano Fernández: So yes.

Elizabeth Plimack: Okay. At the first sign of recurrence in the bladder, cystectomy happens.

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: So these patients don't need a cystectomy right away. You hope they get away without one completely.

Elena Sevillano Fernández: Yeah.

Elizabeth Plimack: Wonderful. So this is a trial in progress.

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: So it's enrolling now-

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: ... all across Spain?

Elena Sevillano Fernández: Well, we have completed the enrollment.

Elizabeth Plimack: Okay.

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: All right.

Elena Sevillano Fernández: And the 70 patients have been recruited in only one year.

Elizabeth Plimack: Amazing.

Elena Sevillano Fernández: Yes. So this is a clear signal that bladder sparing is a need because patient are seeking for that.

Elizabeth Plimack: Right.

Elena Sevillano Fernández: And there's a lot of enthusiasm, not only in the patient, but also in the physician who has been willing to participate in the trial.

Elizabeth Plimack: I really want to underscore what you said. This is UroToday, so we're speaking to a lot of urologists. I'm so grateful that urologists are willing to spare patients cystectomy. Right?

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: You would think that surgeons would want to operate perhaps and do that, but our urologic oncologists are totally aligned for the best outcomes for our patients. And our patients, I agree, they're coming to us for retain trials too.

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: This type of trial and there are others that are opening, which is great, are really what patients need and want.

Elena Sevillano Fernández: Yes.

Elizabeth Plimack: And if together we can show that patients can spare the bladder with the same outcomes as you said, I think it'd be great.

Elena Sevillano Fernández: Yes. Yes. I think the clue is to identify the right patient for the right strategy and to select very careful the patient who can maintain the bladder-

Elizabeth Plimack: Right.

Elena Sevillano Fernández: ... because I think it could be the next future for the right patient. So I think the future or our vision of this trial is to select the right treatment for the right patient and only perform the cystectomy for that patient who really need it.

Elizabeth Plimack: Right, right. Absolutely. Well, thank you so much for presenting this trial.

Elena Sevillano Fernández: Thank you so much.

Elizabeth Plimack: I guess we'll see the results pretty soon.

Elena Sevillano Fernández: Yes, I hope so.

Elizabeth Plimack: ... enrollment. So we'll bring you back to share your results when those are ready.

Elena Sevillano Fernández: Thank you very much.

Elizabeth Plimack: Great, thank you.