Trial results for the EV-202 study (NCT04225117) investigating enfortumab vedotin and pembrolizumab in various solid tumors were posted on ClinicalTrials.gov on 2026-04-13. The study reported an objective response rate (ORR) of 39.0% for the combination therapy in patients with Head and Neck Squamous Cell Carcinoma (HNSCC).
Background
The EV-202 study, officially titled 'A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)', aimed to assess the antitumor activity and safety of enfortumab vedotin as a monotherapy and in combination with pembrolizumab across multiple cohorts of patients with various locally advanced or metastatic malignant solid tumors.
Trial design
The EV-202 study (NCT04225117) was a Phase 2 trial that enrolled 329 participants with locally advanced or metastatic malignant solid tumors. The study evaluated enfortumab vedotin as a monotherapy in cohorts 1-8 and in combination with pembrolizumab in cohort 9. The primary purpose was to determine the antitumor activity of enfortumab vedotin, as measured by confirmed objective response rate (ORR) per RECIST v1.1, and to assess the safety and tolerability of the treatments.
Key results
The trial results reported confirmed objective response rates (ORR) per RECIST v1.1 for various cohorts, as assessed by the investigator. Duration of Response (DOR) was also reported for some cohorts.
- For Cohort 1: HR+/HER2- Breast Cancer, the ORR was 15.6%. The median DOR was 7.23 months.
- For Cohort 2: TNBC Cancer, the ORR was 19.0%. The median DOR was 3.78 months.
- For Cohort 3: Squamous NSCLC, the ORR was 4.3%. The median DOR was 3.71 months.
- For Cohort 4: Non-squamous NSCLC, the ORR was 16.3%. The median DOR was 10.15 months.
- For Cohort 5: Head and Neck Cancer, the ORR was 23.9%.
- For Cohort 7: EAC, the ORR was 9.5%.
- For Cohort 8: ESCC, the ORR was 18.2%.
- For Cohort 9: HNSCC, which investigated the combination of enfortumab vedotin + pembrolizumab, the confirmed ORR was 39.0%.
What this means
The results from the EV-202 trial provide insights into the antitumor activity of enfortumab vedotin as a monotherapy across several solid tumor types and in combination with pembrolizumab for HNSCC. The observed objective response rates, particularly the 39.0% ORR for the combination in HNSCC, suggest potential clinical benefit in these challenging cancer populations. These findings contribute to the understanding of enfortumab vedotin's efficacy profile and its potential role in combination regimens for advanced malignant solid tumors.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04225117, titled 'A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)', were posted on 2026-04-13 on clinicaltrials.gov.