UV1, a Universal Therapeutic Cancer Vaccine, in Combination with Keytruda Achieves 60% Overall Response Rate in First-Line Metastatic Melanoma, Significantly Outperforming Keytruda Monotherapy

May 31, 2021 /BioonBIOON/ --Ultimovacs is a pharmaceutical company developing novel immunostimulatory vaccines for the treatment of cancer. Recently, the company announced itsUniversal Therapeutic Cancer Vaccine UV1 in Combination with MSDTumorKeytruda Immunotherapy(Keytruda, generic name: pembrolizumab)First-line treatment for metastatic malignantMelanomaLatest data from a phase 1 study (NCT03538314). The results showed that patients treated with the UV1 + Keytruda regimenThe objective response rate (ORR) reached 60%.，significantly higher than Keytruda monotherapy (ORR of 33–37%).

UV1 is a peptide-based vaccine capable of inducing immune responses directed against`Tumor`Universal AntigenTelomereEnzyme-specific T cell response.UV1 is a "universal" therapeutic cancer vaccine that can serve as a platform for combination with other immunotherapies requiring sustained T-cell responses to their mechanism of action. To date, it has been evaluated in 4 phase 1Clinical TrialUV1 was evaluated in a total of 82 patients, maintaining a favorable safety and tolerability profile along with encouraging efficacy signals.

The rationale for using UV1 is that advanced malignantMelanomaPatients typically lack relevant T cells and are unable to derive durable benefit from Keytruda monotherapy. UV1 can induce T-cell expansion, thereby potentially increasing targeting ofTumorThe breadth and diversity of immune responses across all sites.

Melanoma (Image source: healthjade.com)

The announced data are from an open-label, multicenter Phase 1 study evaluating the tolerability and efficacy of the UV1 vaccine in combination with Keytruda as first-line treatment for malignant melanoma. Data from a cohort of 20 evaluable patients show 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 datasignificantly outperformed Keytruda monotherapy in advancedMelanomaefficacy data (ORR of 33–37%, CR of 5–12%).

In addition,The median progression-free survival (PFS) with UV1 in combination with Keytruda was 18.9 months.，whereas Keytruda monotherapy for advancedMelanomamedian PFS was 5.5-11.6 months. After 21 months of follow-up, the overall survival rate was 80%, and the median overall survival (OS) had not been reached.

These data indicate that,The combination of UV1 with Keytruda significantly improves therapeutic efficacy.In this study, the combination of UV1 and Keytruda was safe and well-tolerated, demonstrating clinically meaningful response rates.

UV1 Mechanism of Action (Click image to enlarge)

Ultimovacs CEO Carlos de Sousa stated: “These data reinforce our belief that UV1 can play a transformative role in the treatment of diseases such as malignant melanoma. The data show that combining UV1 with checkpoint inhibitors such as Keytruda can mobilize patients’ immune systems to fight cancer. ThisMelanoma“This is very encouraging news for patients and those participating in Ultimovacs’ broader clinical development programs in solid tumors.”

Jens Bjorheim, Chief Medical Officer at Ultimovacs, stated: "These highly robust and exciting data further strengthen the foundation of our Phase 2 clinical program for UV1. Demonstrating high levels of clinical response while maintaining a safe and well-tolerated profile in combination with Keytruda, this underscores our development strategy that UV1 has the potential to significantly enhance treatment efficacy across a broad range of indications and combination regimens." (Bioon.com)

Original Source: Ultimovacs’ UV1 in Combination with Pembrolizumab Shows 60% Objective Response Rate in Advanced Melanoma Phase I data