The UV1-103 study evaluated Ultimovacs’ universal cancer vaccine, UV1, in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line treatment in patients with advanced non-resectable or metastatic malignant melanoma.
The study enrolled 30 patients in the U.S. in two cohorts that differed only in the concentration of GM-CSF used as vaccine adjuvant.
Among the patients in cohort 1 who were alive at the 3-year follow-up, no further deaths have been reported, reaffirming a positive trend of durable overall survival benefit from UV1 vaccination.
The overall survival in cohort 1 after 3-year follow-up was 71%. In addition, 11 out of 16 patients were confirmed alive after 4 years, indicating an overall survival of 69%.
Ultimovacs has previously reported data showing a complete response rate in the UV1-103 study of 33%, complete disappearance of tumors, and an objective response rate of 57%, complete or partial disappearance of tumors.
Biomarker analyses reported in October 2022 also showed robust clinical responses in patients treated with the combination of UV1 and pembrolizumab.
Ultimovacs is now investigating UV1 in malignant melanoma in its randomized phase 2 INITIUM trial of UV1 in combination with ipilimumab and nivolumab.
The trial completed enrollment of 156 patients with advanced non-resectable or metastatic malignant melanoma in July 2022. The top-line results will be disclosed after cancer progression has been verified in 70 patients.
The outcome of the upcoming study is expected to be announced in the first half of 2024.
Jens Bjørheim, chief medical officer at Ultimovacs, said: “We are very encouraged to report a durable and long-term overall survival rate at the 4-year follow-up in the UV1-103 study. The data further strengthen the previously reported results from the study, including good safety for UV1 and the high number of complete responses in patients with metastatic malignant melanoma where surgery is not an option. The UV1-103 study treats the same patient population as our Phase II study INITIUM. As we await data from the first three randomized UV1 Phase II trials in the near-term, we are increasingly optimistic about UV1’s potential to benefit cancer patients.”