Patient-Reported Outcomes with EV-Pembrolizumab vs Cystectomy Alone in MIBC - Peter O'Donnell

August 5, 2026

Peter O'Donnell shares a PRO analysis from KEYNOTE-905 comparing EV plus pembrolizumab against cystectomy alone in muscle-invasive bladder cancer. The analysis incorporated general health-related QoL scales alongside bladder cancer-specific and cystectomy-specific instruments. No significant health-related QoL decrement was observed with EV plus pembrolizumab, while in both arms decreases in bowel and sexual function appeared after cystectomy and improved over time. Dr. O'Donnell notes the study was the first to generate PRO data in the perioperative muscle-invasive bladder cancer setting.

Biographies:

Peter O’Donnell, MD, Fred C. Buffett Professor of Medicine, University of Chicago Medicine, Chicago, IL

Elizabeth Plimack, MD, MS, FASCO, Professor, Temple Health, Deputy Director, Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA


Read the Full Video Transcript

Elizabeth Plimack: Hi, I'm Elizabeth Plimack. I'm a GU medical oncologist at Fox Chase Cancer Center in Philadelphia and I'm here with Peter O'Donnell, GU medical oncologists here at University of Chicago. So Peter, great presentation this morning. KEYNOTE-905 really just revolutionized how we treat muscle-invasive bladder cancer. Super exciting data. But what we didn't hear a lot about in the initial presentations was the quality of life and how this affects patients, right? We're curing so many more patients with this new approach, but what are the downstream implications? How do we think about them and how can we prepare our patients going into this? So tell us a little bit about the analysis you did and what you found.

Peter O'Donnell: As you mentioned, these are the first time we're seeing PRO data I think in the perioperative setting. And so it's a little different for us to get our minds around and what we'd be thinking about. So I think one of the advantages of the 905 quality of life data is it used the general health related quality of life scales, overall health assessment, but it also added too bladder cancer specific-

Elizabeth Plimack: Right.

Peter O'Donnell: And cystectomy specific PRO measures, instruments. And I thought that added something to what we were looking at. So I don't know if you want me to get into the main findings.

Elizabeth Plimack: Absolutely. Yeah. Tell us what the findings were. Obviously, how we measure quality of life is important and fortunately changing and evolving-

Peter O'Donnell: Correct.

Elizabeth Plimack: With how our treatments change. But tell us what you found with the data.

Peter O'Donnell: Perhaps not surprisingly, right, we didn't see detriments in health related quality of life with the EV pembrolizumab regimen in this trial. The PROs were also done in the cystectomy alone arm-

Elizabeth Plimack: Right.

Peter O'Donnell: Which was of course the control arm. And we didn't see large decrements there in overall health related quality of life, overall cystectomy specific quality of life. We did see some decreases in specific measures that we might expect from cystectomy-

Elizabeth Plimack: That's right.

Peter O'Donnell: Decreases in bowel function, decreases in sexual function. That happened in both arms and it really seemed to be timed after the cystectomy event and then would improve over time in the post-surgery phase. But so I actually think it validated the measures a little bit, that we were able to detect these clear side effects, expected effects of a cystectomy, but we didn't really see a lot of other decrement in health related quality of life with the EV pembrolizumab addition.

Elizabeth Plimack: That's amazing and that's great to see, right? I mean, EV pembrolizumab versus nothing. So it really was a control arm where they did not get the systemic therapy. But let's talk a little bit about what we learned about cystectomy as part of the PROs from this trial. Obviously, major impact on our patients. They tell us this in clinic, we know this. How do you think that knowledge is going to parlay into where we go next with EV+P for bladder cancer?

Peter O'Donnell: What everybody's thinking about is, could we do something different than taking the patient's bladder out? And it's really a question, as you know, that every patient comes in the door asking about now. I don't know in your practice, but in mine over the last year or so, especially since the data came out last fall, patients are asking that question and it's increasingly more difficult to tell them a reason that they need to have the bladder out. Of course, that's still the standard right now, but I think these PRO data really add to us thinking about what is the cost-

Elizabeth Plimack: Right.

Peter O'Donnell: The functional cost to a patient to have to undergo cystectomy and what if a large number of those patients really don't need that with the very effective systemic therapies that we have.

Elizabeth Plimack: Absolutely. And especially because you showed us they really tolerate it well.

Peter O'Donnell: Correct.

Elizabeth Plimack: Their PROs aren't impacted. The systemic therapy is maybe the easy part. The surgery is maybe the harder part of this, right?

Peter O'Donnell: Correct.

Elizabeth Plimack: Yeah.

Peter O'Donnell: Correct.

Elizabeth Plimack: Absolutely. Well, thank you so much, Peter, for joining us and presenting such great data.

Peter O'Donnell: Thanks very much.