Ultimovacs has announced 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 have been observed for at least 18 months and median observation time is 21 months.
“Further strengthen the foundation for our broad Phase II clinical program for UV1”
The 60% ORR with 30% CR, clearly exceeds the response rate for pembrolizumab alone in advanced melanoma, states the company in a press release. 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,” says Jens Bjørheim, Chief Medical Officer at Ultimovacs. “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.”
Data from a Phase I study
The data comes from Ultimovacs’ open-label Phase I study (NCT03538314). 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.
“It suggests that UV1 in combination with checkpoint inhibitors like pembrolizumab can mobilize the immune system to fight cancer.”
“These data reinforce our conviction that UV1 can play a transformative role in the treatment of conditions such as malignant melanoma,” says Carlos de Sousa, CEO of Ultimovacs. “It suggests that UV1 in combination with checkpoint inhibitors like pembrolizumab can mobilize the immune system to fight cancer. This is very encouraging for melanoma patients and for those involved with the roll-out of Ultimovacs’ broader programs in solid cancers.”