ESMO 2025 | KEYNOTE-905/EV-303: perioperative EV and pembrolizumab in MIBC

Right, so EV303 is a very important study in the field because what this study was is looking at cisplatin-ineligible muscle-invasive bladder cancer, where the standard of care is to go to upfront radical cystectomy. So these patients are not fit for cisplatin. So in these patients, in this trial, the investigators examined EV plus pembrolizumab given preoperatively in the experimental arm. So it was three cycles of EV pembrolizumab pre-op and another six cycles of post-op EV and another nine months of post-op pembrolizumab to complete a year of pembrolizumab. The control arm was going to upfront radical cystectomy. So the trial is positive for both event-free survival and overall survival. The hazard ratio for event-free survival was 0.4. The hazard ratio for overall survival was 0.5. So very promising. So this is, I consider a practice-changing trial. We expect this to hopefully be in the clinic. This trial did include cisplatin-ineligible as well as cisplatin-declining patients. So approximately 15% of patients in the study were cisplatin-declining. At the end of the day, therefore, a small subset is tough to tease out in the sub-analysis. So I think that this regimen will constitute a choice for patients who are cisplatin-ineligible or cisplatin combination chemotherapy refusing or declining. Now remember that cis-gem-durvalumab is already approved in cisplatin-eligible patients. So the decision for us in the clinic now, if this regimen is approved, is, do we do GEMCIS-durvalumab or do we do EV-pembrolizumab? So I think this is really in the judgment of the investigator, the treating physician and the patient, they will look at the data. Unfortunately, some comparison across studies. But again, remember in this study, the pCR rate, which was a secondary endpoint, was also quite impressive, was which is quite impressive by an intention to treat analysis in the GC-durva study the pCR rate was 37% approximately with GC-durva again this is comparison across studies but I think most people will look at this and consider EV-pembrolizumab a strong regimen for cisplatin-ineligible or cisplatin-declining patients with muscle-invasive bladder cancer.

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