Universal Cancer Vaccine Candidate Shows Positive Impact
Ultimovacs ASA announced positive 5-year Overall Survival (OS) data from the Phase I trial evaluating the company's universal cancer vaccine, UV1, in combination with the checkpoint inhibitor, ipilimumab, in patients with metastatic malignant melanoma.
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase.
The company reported after 5-years of follow-up, 50 percent of the patients in the open-label trial was alive, providing encouraging signals of long-term survival benefit for UV1 in this late-stage patient population and as compared to historical data of ipilimumab monotherapy.
These results represent the third clinical trial with UV1 to provide positive data for 5-years of patient follow-up, further strengthening UV1's profile as a safe and potentially effective addition to immuno-oncology treatment regimens.
"When we look at the trial results of ipilimumab monotherapy conducted in nearly identical clinical settings and patient population, we see in the literature a 5-year survival rate around 20 percent, the median overall survival of around 16 months and median progression-free survival of about 3.5 to 4 months," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs, in a press release.
"Combining ipilimumab, which was the standard-of-care treatment at the time of the study initiation, with UV1, resulted in promising signs of improved survival with a safe and well-tolerated profile.”
“At 5 years of follow-up, the median overall survival had not been reached and 50% of the patients were still alive, which are encouraging results in patients with metastatic melanoma,” added Bjørheim.
A total of 12 malignant melanoma patients with metastatic disease were treated in the Phase I trial. Eight patients of the 12 received UV1 combined with ipilimumab as first-line treatment, and the remaining four patients received the combination after progression on previous systemic treatment.
Immune responses toward the UV1 peptides occurred very early post-administration, with 91 percent of the evaluable patients showing an immune response. In the efficacy-evaluable patient population, one patient achieved a complete tumor response and 3 patients achieved a partial response, resulting in an objective response rate of 44 percent.
Primary endpoints for the study included the safety and tolerability of UV1 as well as initial signs of clinical response. As per the data cut-off at the end of November 2020, every patient in the trial reached at least 60-months of follow-up post-treatment with UV1 and ipilimumab.
At the five-year mark, the OS rate was 50 percent, median OS had not yet been reached, and the median Progression-Free Survival (mPFS) was 6.7 months. Over the course of the follow-up period, none of the patients experienced any unexpected safety issues related to UV1.
"In all four Phase I trials where UV1 has been tested, we have observed a consistent set of positive signals of clinical effect and a good safety profile for UV1. This strengthens our commitment to developing UV1 as a potential universal cancer vaccine that can be applied across multiple indications, in different combinations with other cancer treatments, and in different stages of cancer," added Carlos de Sousa, Chief Executive Officer at Ultimovacs.
"Our ongoing INITIUM Phase II clinical trial combines UV1 with ipilimumab and nivolumab in this patient population and today's results reinforce the confidence we have in our approach of directing the immune system towards telomerase expressing cancer cells to improve clinical outcomes for patients in need of new treatment options."
UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy that requires an ongoing T cell response for their mode of action.
To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.
Ultimovacs' UV1 universal cancer vaccine candidate leverages the high prevalence of the human telomerase to be effective across the dynamic stages of the tumor's growth and its microenvironment.
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