Clinical Trial Info

UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

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UV1 is a therapeutic cancer vaccine that has been explored in prostate and lung cancers, and in combination with ipilimumab in malignant melanoma.

This study will explore the safety, tolerability and efficacy of UV1 administered with GM-CSF in melanoma patients who are also receiving pembrolizumab.

Interim Results

UV1, in combination with the checkpoint inhibitor pembrolizumab, demonstrated a 60% objective response rate (ORR) in metastatic malignant melanoma.

All patients have been observed for at least 18 months and the median observation time is 21 months. The results will be presented as an online poster at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting.

The 60% ORR (6 complete responses (CR); 6 partial responses (PR) from a 20-patient cohort) with 30% CR, clearly exceeds the response rate for pembrolizumab alone in advanced melanoma (33-37% ORR and 5-12% CR)*.

The median progression-free survival for the UV1/pembrolizumab combination in the study was 18.9 months compared with 5.5-11.6 months* for pembrolizumab alone in advanced melanoma.

The overall survival was 80%, with the median overall survival yet to be reached after 21-months of follow-up.