ESMO 2026 | The evolving role of EV plus immunotherapy in muscle-invasive bladder cancer
Jens Bedke, MD, Klinikum Stuttgart, Stuttgart, Germany, discusses the evolving treatment landscape for muscle invasive bladder cancer, highlighting the positive results from the EV-302 (NCT04223856) and EV-303 (NCT03924895) trials (KEYNOTE-B15 and KEYNOTE-905) that evaluated the combination of enfortumab vedotin (EV) plus pembrolizumab in the perioperative setting. The VOLGA (NCT04960709) trial also further confirms the efficacy of EV combined with durvalumab in cisplatin-ineligible patients, supporting the use of antibody-drug conjugate combinations with immune checkpoint inhibitors as the preferred approach when available. For patients without access to EV-based regimens, gemcitabine-cisplatin plus durvalumab remains a valid alternative in the cisplatin-ineligible population. This interview took place at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid, Spain.
These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.
Transcript
I think the journey started 12 months ago at this year’s ESMO meeting 2025, and continued at the FDA. And now we are at the ASCO-GU meeting 2026, with the presentation of the EV302 and the EV303 trials, so KEYNOTE-B15 and KEYNOTE-905, the trials exploring the combination of the ADC enfortumab vedotin plus pembrolizumab with cystectomy, and then followed by adjuvant EV plus pembrolizumab in this perioperative space of muscle invasive bladder carcinoma...
I think the journey started 12 months ago at this year’s ESMO meeting 2025, and continued at the FDA. And now we are at the ASCO-GU meeting 2026, with the presentation of the EV302 and the EV303 trials, so KEYNOTE-B15 and KEYNOTE-905, the trials exploring the combination of the ADC enfortumab vedotin plus pembrolizumab with cystectomy, and then followed by adjuvant EV plus pembrolizumab in this perioperative space of muscle invasive bladder carcinoma. So we all learned that these trials were highly POSITIVE and really evolving the field with, like, revolutionary, as we have observed, that of this ADC combination of the metastatic setting of urothelial carcinoma. So all these trials of EV plus pembrolizumab were POSITIVE for the primary endpoints of event-free survival and the key endpoints for overall survival, and the increase of pathological complete response rate up to a remarkable level of 57%. So you ask me, what is the alternative using an immune checkpoint inhibitor in this setting? I think these trials EV303 and EV304 clearly demonstrate that the role of a PD-1 antagonism with pembrolizumab is well given in this muscle invasive bladder carcinoma in the use and the combination of an antibody drug conjugate, namely the enfortumab vedotin. And we also learned at this ESMO meeting, and this is quite new data, that the results from the VOLGA trial, which is a trial also in this perioperative setting in the cisplatin ineligible population, used enfortumab vedotin for three cycles together with an immune checkpoint inhibitor. the durvalumab, the PD-L1 antibody, And it’s very reconfirming, reassuring that the combination of the enfortumab vedotin provided the same results of a significant event-free survival improvement and overall survival improvement in that setting. So to summarize that, I think if you have the availability, the access and the reimbursement to an EV, enfortumab vedotin-based combination in the perioperative setting, we shall use that. If there’s no approval and no access at the end, we know. But you just should remember that for the cisplatin ineligible population, the combination of gemcitabine cisplatine plus durvalumab is a very valid option.
This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.
Read more...
