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“Universal” therapeutic cancer vaccine! UV1 combined with Keytruda in the first-line treatment of malignant melanoma: the total remission rate is 60%, far exceeding Keytruda!
UV1 combined with Keytruda to treat malignant melanoma with 60% remission. Ultimovacs is a pharmaceutical company that develops new immunostimulatory vaccines to treat cancer.
Recently, the company announced a phase 1 study of its universal therapeutic cancer vaccine UV1 combined with Merck’s tumor immunotherapy Keytruda (pembrolizumab, pembrolizumab) as the first-line treatment of metastatic malignant melanoma (NCT03538314) ) Latest data.
The results showed that the objective response rate (ORR) of UV1+Keytruda regimen treatment reached 60%, which was significantly higher than that of Keytruda monotherapy (ORR was 33-37%).
UV1 is a peptide-based vaccine that can induce a specific T cell response to the tumor universal antigen telomerase. UV1 is a “universal” therapeutic cancer vaccine that can be used as a platform in combination with other immunotherapies that require T cells to continuously respond to its mode of action. So far, UV1 has been tested in a total of 82 patients in 4 phase 1 clinical trials, and has maintained positive safety and tolerability as well as encouraging efficacy signals.
The basic principle of using UV1 is that patients with advanced malignant melanoma usually lack the relevant T cells and cannot obtain long-lasting benefits from the use of Keytruda alone. UV1 can expand T cells, which has the potential to increase the breadth and diversity of the immune response to all parts of the tumor.
Melanoma (Image source: healthjade.com)
What is announced this time is an open-label, multi-center Phase 1 study that is evaluating the tolerability and efficacy of the UV1 vaccine combined with Keytruda in the first-line treatment of malignant melanoma. Data from a cohort of 20 evaluable patients showed that the ORR was 60% (n=12), the complete response rate (CR) was 30% (n=6), and the partial response rate (PR) was 30% (n=6) . This data significantly exceeds the efficacy data of Keytruda as a single agent for advanced melanoma (ORR is 33-37%, CR is 5-12%).
In addition, the median progression-free survival (PFS) of UV1 combined with Keytruda treatment was 18.9 months, while the median PFS of Keytruda monotherapy for advanced melanoma was 5.5-11.6 months. After 21 follow-ups, the overall survival rate was 80%, and the median overall survival (OS) has not yet been reached.
These data show that the combined application of UV1 on the basis of Keytruda can significantly improve the therapeutic effect. In this study, the combination of UV1 and Keytruda was safe and well tolerated, showing a beneficial level of clinical response.
Mechanism of UV1 (click on the picture to see a larger picture)
Carlos de Sousa, CEO of Ultimovacs, said: “These data strengthen our belief that UV1 can play a transformative role in the treatment of diseases such as malignant melanoma. The data show that the combination of UV1 and Keytruda and other checkpoint inhibitors can mobilize The patient’s immune system fights cancer. This is very encouraging news for melanoma patients and those involved in Ultimovacs’ broader clinical development program for solid cancer.”
Ultimovacs Chief Medical Officer Jens Bjorheim said: “These very powerful and exciting data further strengthen the foundation of our UV1 Phase 2 clinical project. The combination with Keytruda is safe and well tolerated, while showing a high level of Clinical remission, which underscores our development strategy that UV1 has the potential to significantly improve the therapeutic effect in a wide range of indications and combination drugs.”
UV1 combined with Keytruda to treat malignant melanoma with 60% remission
(source:internet, reference only)