Cohort 9 of the Phase 2 EV-202 Trial: First-Line Enfortumab Vedotin Plus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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Welcome to DataPulse from ESMO 2025 on ReachMD. This activity, titled “Cohort 9 of the Phase 2 EV-202 Trial: First-Line Enfortumab Vedotin Plus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma” is provided by Prova Education.

Dr. Swiecicki:
Hi. My name is Paul Swiecicki. I'm at ESMO 2025, and I just presented the results of Cohort 9 from the EV-202 trial.

As you may recall, Cohort 5 of the EV-202 trial evaluated enfortumab vedotin monotherapy in multi-refractory metastatic head and neck squamous cell carcinoma. In that cohort, enfortumab demonstrated a response rate of approximately 25%, many of which were durable.

Due to this data from the heavily pretreated population, plus the data regarding EV plus pembrolizumab in metastatic urothelial carcinoma, we evaluated enfortumab plus pembrolizumab in PD-1–positive first-line head and neck squamous cell carcinoma. This trial enrolled approximately 41 patients, from which the confirmed overall response rate was the primary endpoint.

In our study, the primary endpoint was positive. We found a response rate of approximately 37%, and from there, 10% of responses were complete responses. Furthermore, the median PFS was 5.1 months; the median OS has not yet been reached.

The toxicities seen with this were on par with that seen from metastatic urothelial carcinoma. This is very exciting. This is the first data regarding first-line antibody-drug conjugates plus immunotherapy in metastatic head and neck cancer, and there was no undue toxicity profile. The response rate was above that which was statistically anticipated, and we're very excited to see the future of antibody-drug conjugates in head and neck cancer. Thank you.

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