Positive Results Observed With UV1 Cancer Vaccine Plus Pembrolizumab in Metastatic Melanoma


The results from a phase 1 trial that focused on a second cohort of patients with unresectable or metastatic melanoma identified positive safety and promising topline survival outcomes when treated with the combination of UV1 and pembrolizumab.

Positive topline results were reported from a phase 1 clinical trial (NCT03538314) evaluating the cancer vaccine UV1 in combination with pembrolizumab (Keytruda) as a first-line therapy for patients with unresectable or metastatic malignant melanoma, according to a press release from vaccine developer Ultimovacs ASA.

The primary end points of safety and tolerability were met, with data from the trial also highlighting early signs of clinical response among patients treated with the cancer vaccine combination.

After 1 year, results from the second cohort, which included 10 patients with unresectable or metastatic melanoma, identified tumor shrinkage in 6 patients, which translated to an objective response rate of 60%. The complete response rate, defined as tumor shrinkage to undetectable levels, was reportedly 30% in the second cohort of patients. These data align similarly with the results reported from the first cohort of 20 patients in this phase 1 study.

“The emerging picture is that the UV1-pembrolizumab combination has a strong safety profile and provides consistently high levels of clinical response in advanced melanoma,” Jens Bjørheim, chief medical Officer of Ultimovacs, explained in a press release. “[These] latest data add to the accumulating body of evidence demonstrating that UV1 is safe and can mobilize the immune system to play a transformative role in the treatment of solid tumors.”

Additional data indicated that the 1-year overall survival (OS) rate for patients included in the second cohort was 90%, with a rate of 85% noted in the study’s first cohort. Median progression-free survival was not reached in both the first and second cohorts of patients at 12 months, which suggests that at least half of the patients in each cohort experienced disease improvement or stability.

The study is currently ongoing and researchers expect that the topline 2-year follow-up data focusing on the first cohort of patients in this phase 1 trial will be reported in Q4 of 2021.

Eligible patients for this trial were 18 years or older, with stage 3B, 3C, or 4 melanoma and no prior treatments. Additionally, patients needed to be eligible for pembrolizumab therapy, as well as having had adequate blood, liver, and kidney function.

“These latest results are compelling, and in line with the data presented at ASCO from the first group of patients in this study,” Carlos de Sousa, CEO of Ultimovacs, said in a press release. “We will discuss these results further when we present the company’s Q2 2021 financial results to shareholders on August 20, 2021. We also plan to share more detailed results of the study at a major clinical oncology meeting in 2022.”


Ultimovacs announces further positive topline results from phase I UV1 cancer vaccine combination study in metastatic Melanoma. News release. Ultimovacs ASA. August 12, 2021. Accessed August 13, 2021. https://tinyurl.com/xvk244ca

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