Ultimovacs has announced continuing positive topline results in its ongoing US-based Phase I clinical trial evaluating the company’s universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab as a first-line treatment in metastatic malignant melanoma.
The trial had previously reached its primary endpoint of safety and tolerability and at 24 months of follow-up continues to demonstrate strong signs of clinical response.
“The combination of UV1 and pembrolizumab has a strong safety profile and provides a prolonged and effective clinical response in advanced melanoma,” says Jens Bjørheim, Chief Medical Officer of Ultimovacs. “These two-year follow-up data suggest that the way in which UV1 mobilizes the immune system provides patients with lasting benefits.”
The Phase I trial
In the Phase I trial, patients were treated initially for 14 weeks with UV1 in combination with pembrolizumab. At the cut-off date of October 12, 2021, every patient in the first cohort had been followed for at least 24-months from the start of their treatment. The overall survival rate after two years of follow-up was 80% in this first cohort of 20 patients. As previously announced, median progression free survival for these patients was 18.9 months.
The 24-month follow-up data compares favorably with an earlier large-scale study of pembrolizumab alone, which showed an overall survival rate of 58% after 24 months and median progression-free survival of 5.5-11.6 months.
“We believe that UV1 will play a transformative role in the treatment of solid tumors, elevating patients’ response rates in combination with checkpoint inhibitors and providing long-term clinical benefits,” says Carlos de Sousa, CEO of Ultimovacs. “We look forward to sharing more detailed results of this ongoing study at a major clinical oncology meeting in 2022.”
Photo of Carlos de Sousa: Ultimovacs