Ultimovacs ASCO 2021 60% ORR 30% CR #cancervaccine
Ultimovacs’ UV1 in combination with pembrolizumab shows 60% Objective Response Rate in advanced melanoma Phase I data
• UV1/pembrolizumab results in 30% complete responses plus 30% partial responses
• Good safety and tolerability profile supports use of UV1 in combination treatments
• Data to be presented at ASCO and abstract to be discussed in webcast on May 20, 2021
Oslo, 19 May 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, today 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. 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.
“These very strong and exciting data further strengthen the foundation for our broad Phase II clinical program for UV1,” said 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.”
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 the use of 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 at ASCO, 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.
“These data reinforce our conviction that UV1 can play a transformative role in the treatment of conditions such as malignant melanoma,” said 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.”
Webcast
A corporate webcast will be held on Thursday 20 May 2021, 10:00 CEST. Carlos de Sousa, CEO of Ultimovacs and Jens Bjørheim, CMO, will discuss the ASCO abstract. It will be possible to submit written questions during the presentation. The webcast will be available subsequently on the company website;
• UV1/pembrolizumab results in 30% complete responses plus 30% partial responses
• Good safety and tolerability profile supports use of UV1 in combination treatments
• Data to be presented at ASCO and abstract to be discussed in webcast on May 20, 2021
Oslo, 19 May 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, today 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. 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.
“These very strong and exciting data further strengthen the foundation for our broad Phase II clinical program for UV1,” said 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.”
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 the use of 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 at ASCO, 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.
“These data reinforce our conviction that UV1 can play a transformative role in the treatment of conditions such as malignant melanoma,” said 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.”
Webcast
A corporate webcast will be held on Thursday 20 May 2021, 10:00 CEST. Carlos de Sousa, CEO of Ultimovacs and Jens Bjørheim, CMO, will discuss the ASCO abstract. It will be possible to submit written questions during the presentation. The webcast will be available subsequently on the company website;