60% Objective Response Rate Demonstrated in Advanced Melanoma Treatment Study

Norway-based Ultimovacs ASA announced today that its universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab, demonstrated a 60% objective response rate (ORR) in metastatic malignant melanoma.

All patients in this phase 1 study have been observed for at least 18 months, and the median observation time is 21 months.

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.

“These very strong and exciting data further strengthen the foundation for our broad Phase II clinical program for UV1,” commented Jens Bjørheim, Chief Medical Officer at Ultimovacs, in a press statement.

“To show this level of beneficial clinical response while being safe and well-tolerated in combination with pembrolizumab underscores our development strategy to show that UV1 can provide a significant increase in therapeutic effect in a broad range of indications and combinations.”

The company says the 'rationale for the use of UV1 is that patients with advanced malignant melanoma often lack the relevant T cells to obtain durable benefits from pembrolizumab alone. UV1 expands T cells that have the potential to increase the breadth and diversity of the immune response towards all parts of the tumor.'

The data comes from Ultimovacs’ open-label Phase I study (NCT03538314) and will be shown as a poster presentation to be held virtually Friday, June 4, 2021, through Tuesday, June 8, 2021. The data also shows that the UV1/pembrolizumab combination is well tolerated, with adverse events largely restricted to low-grade effects, mainly injection site reactions.

Ultimovacs was established in 2011, and its proprietary technology is based on clinical research conducted at the Oslo University Hospital. The company is a limited public liability company listed on the Oslo Stock Exchange in Norway.