UV1 Cancer Vaccine Receives FDA Fast Track Designation in Melanoma


UV1 has received fast track designation from the FDA for the use in unresectable or metastatic melanoma.

UV1, a universal cancer vaccine, has received fast track designation from the FDA for the treatment of unresectable or metastatic melanoma as an add on to treatment with pembrolizumab (Keytruda) or ipilimumab (Yervoy), according to a press release from the vaccine’s maker Ultimovacs.

The designation is based on results from 2 separate phase 1 trials of UV1 in combination with pembrolizumab (NCT03538314) and UV1 with ipilimumab (NCT02275416).

“We are delighted UV1 has received the fast track designation and look forward to working more closely with the FDA to bring UV1 to melanoma patients as soon as possible,” Carlos de Sousa, Chief Executive Officer of Ultimovacs, said in the press release.

Patients given pembrolizumab (N = 30) had an objective response rate (ORR) of 57% and a complete response (CR) rate of 30%. At the 24 months follow-up, 80% of patients in cohort 1 were alive. In a second cohort, 90% of patients were alive after 12 months.

A total of 8 patients had a partial response and 2 had stable disease. Median progression-free survival in cohort 1 was 18.9 months and was not reached at 12 months in cohort 2. In cohort 1, the 12-months OS rate was 85%.

In cohort 1, there were 20 patients enrolled who were given UV1 plus pembrolizumab and granulocyte-macrophage colony-stimulating factor (GM-CSF) at 37.5 μg. In cohort 2, 10 patients received the same regimen with GM-CSF at 75 μg. The primary end point was safety, and secondary end points were immune response and efficacy descriptive. The safety profile was similar to the known effects of anti­–PD-1 antibodies, but patients did experience some injection site reactions.

In the trial of ipilimumab, patients had an ORR of 33% and a 5-year overall survival (OS) rate of 50%. A total of 12 patients given UV1 plus ipilimumab, were alive at 60 months and the median progression-free survival (PFS) was 6.7 months.

The phase 2 INITIUM trial (NCT04382664) is currently underway looking at nivolumab (Opdivo) with ipilimumab with or without UV1. The primary end point is PFS with secondary end points of OS, ORR, duration of response, and safety.

UV1 is also currently also being studied in additional phase 2 trials for ovarian cancer, head and neck squamous cell carcinoma, and malignant pleural mesothelioma.


1. Ultimovacs receives dual FDA fast track designation for UV1 in advanced malignant melanoma. News Release. Ultimovacs. October 21, 2021. Accessed November 3, 2021. https://yhoo.it/3EGi7mh

2. Enabling the immune system to fight cancer. Ultimovacs. Webcast. October 21, 2021. Accessed November 3, 2021. https://bit.ly/3k521uy

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