ESMO 2026 | EV-303: long-term subgroup outcomes with EV and pembrolizumab in la/mUC

Yeah, EV303 trial, just to remember you, is the combination of Enfotimab vDOTin plus Pembrolizumab in the metastatic locally advanced setting in the first line. And it was initially designed. To use EV plus Pembrolizumab versus platinum-based chemotherapy. And it surpassed platinum-base chemotherapy in a revolutionary way by doubling the PFS by doubling DOS. And we all know back to the platinum – base era that platin, carboplatin, cisplatin combinations worked well, let’s say, with a different kind of efficacy in specific patient subgroups. We learned from the platinum era that pure bladder carcinoma, urethra carcinomas are originating from the bladder, is different and has a better prognosis if compared to the upper tract. And we also learned from Joaquin Bellmmunt who definitely elaborated a very nice criteria, the Bellmann criteria for worse prognoses in these patients like liver metastasis, visceral metastases who respond poorly. So what have we done? We analyzed the specific clinical key relevant subgroups with the combination of enfortumab vedotin plus Pembrolizumab versus the platinum-based chemotherapy based on these results of EV3 or 2, with a longer follow-up, so the minimum follow – up is now three and a half years. And at the end, what we found there is consistency. So if we start with the urethra carcinoma originating from the bladder compared to the upper tract, the benefit is very well given if compared to the platinum base chemotherapy. And going to the raw numbers and the numerical improvement, it’s in the same direction actually reaching the same level of MAGNITUDE of additional benefit with EVP if compared to platinum-base chemotherapy. And the same applies for, well, let’s say different locations of metastasis like the liver metastases, visceral metastase, for lung metastasizes. So people are responding very, very well with the improvement of PFS and overall survival. We observed one effect, to be very honest, and we know that lymph node metastases, just pure lymph node, metastasis, patients of that in the metastatic status, they have an excellent prognosis. And this was definitely also the case for EV-P. And I think we have a good message here that the combination of enfortumab vedotin plus pembrolizumab is highly activeirrespective of any clinical relevant subgroup. And if you divide the clinical relevant groups, yes, of course, patients with lymph node metastase, for example, are doing very well. We could also extendthat to patients of comorbidities. That was the second post that we presented. And don’t hesitate on patients of co-morbidity because the treatment is manageable. It’s active. And that’s the second very important message for our patients in the setting.

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