ESMO 2025 | EV-103 Cohort K: long-term outcomes of EV ± pembrolizumab in la/mUC
Terence Friedlander, MD, University of California, San Francisco, CA, discusses updated results from Cohort K of the Phase Ib/II EV-103 study (NCT03288545), which assessed enfortumab vedotin (EV) with or without pembrolizumab in cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). With a median follow-up of around 3.5 years, EV plus pembrolizumab maintained high and durable response rates, prolonged progression-free and overall survival, and showed manageable safety, reinforcing its role as a first-line standard of care in this setting. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
EV-103 Cohort K is a Phase I/II trial exploring the combination of enfortumab vedotin and pembrolizumab. It’s the first ever combination study exploring this treatment for advanced bladder cancer. We’re specifically looking in patients who are cisplatin ineligible, a typically poor prognosis group. And we were able to present the updated analysis from the study with 3...
EV-103 Cohort K is a Phase I/II trial exploring the combination of enfortumab vedotin and pembrolizumab. It’s the first ever combination study exploring this treatment for advanced bladder cancer. We’re specifically looking in patients who are cisplatin ineligible, a typically poor prognosis group. And we were able to present the updated analysis from the study with 3.5 years of median follow-up. What we saw was that the results very much sort of mirror what we saw in EV302. We’ve seen that median OS is about 30 months. The median PFS in our study was close to 30 months as well, which was actually longer than we saw in the phase three trial. The overall response rate mirrored the phase three as well with about 65% of patients having any response. Of that, about 15% had a CR and the rest had PRs. And the rate of primary progressive disease was about the same as in the phase three trial, which was about 8%. There was really no new safety signals with longer follow-up. We do see peripheral sensory neuropathy in the majority of patients, almost 60% of patients, and we see skin reactions in about 50% of patients.
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