Ultimovacs has announced continuing positive efficacy data in its ongoing US-based phase I clinical trial, UV1-103.
The study evaluates the company’s universal cancer vaccine, UV1, in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line treatment in advanced non-resectable and metastatic malignant melanoma patients.
“Given the historic trajectory for patients with metastatic malignant melanoma, this three-year 71% OS rate is very positive,” commented Carlos de Sousa, CEO of Ultimovacs in the company’s press release. “Overall, these promising data support our continuing belief that UV1 can play a transformative role in treating solid tumors in combination with checkpoint inhibitors, providing long-term clinical benefits for patients with unmet medical needs.”
“These three-year data also signal that UV1 continues to mobilize the immune system providing patients with a long-term, effective clinical response.”
After the study ended at two years follow up, the protocol was amended to follow patients for overall survival for up to five years. Three of the patients, all in cohort 1, did not consent to further follow up, changing the number of participating patients in cohort 1 from 20 to 17 after two years. In addition, one patient died within the past year.
At the three years cut-off date for patients in the first cohort the three-year overall survival (OS) rate was 71% (12/17). The trial has shown a consistently high OS rate; in this patient cohort it was 85% (17/20) after one year and 80% (16/20) after two years follow-up. Having already reached its primary endpoint of safety and tolerability, the UV1-pembrolizumab combination continues to demonstrate strong signals of clinical efficacy in both response rates and extended survival.
Pembrolizumab is a standard of care for patients with unresectable or metastatic melanoma, based on data from the KEYNOTE-006 trial. Follow up of first-line patients with metastatic melanoma in that trial showed an overall survival rate of 51% at 36 months, describes the company in its press release.
“The high survival rate after three years for metastatic malignant melanoma patients is very encouraging and reinforces the positive data we have consistently observed throughout the UV1-103 trial,” said Jens Bjørheim, Chief Medical Officer of Ultimovacs. “As previously reported, the combination of UV1 and pembrolizumab has a strong safety and tolerability profile. These three-year data also signal that UV1 continues to mobilize the immune system providing patients with a long-term, effective clinical response. We are very pleased to see the positive results for these patients.”
Photo of Jens Bjørheim: Ultimovacs
