Combination treatment with the universal cancer vaccine, UV1, and the immune checkpoint inhibitor, pembrolizumab showed strong signals of clinical response in patients with metastatic melanoma while also meeting its key safety/tolerability end point.
Combination treatment with the universal cancer vaccine, UV1, and the immune checkpoint inhibitor, pembrolizumab (Keytruda) showed strong signals of clinical response in patients with metastatic melanoma while also meeting its key safety/tolerability end point, according to findings announced in a press release by Ultimovacs ASA.1
In 60% of the patients treated with UV1 and pembrolizumab, tumor shrinkage was reported. Tumors were also reduced to undetectable levels n 3 patients, achieving a 30% complete response rate. The findings were noted to be consistent with data from the first 20 patients treated in this 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,” said Jens Bjørheim, chief medical officer of Ultimovacs. “This latest data adds 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.”
The phase 1, open-label, multicenter study of UV1 in combination with pembrolizumab had a target enrollment of 30 patients. Those enrolled are assessed for the primary end point of the number of patients with treatment-related adverse events and the secondary end points of tumor response per RECIST v1.1 and overall survival (OS).2
To be eligible for inclusion, patients were required to have stage IIIB, IIIC, or IV melanoma, be previously untreated and eligible for pembrolizumab treatment, and have adequate blood, liver, and kidney function.
Individuals were excluded from the study if f hematologic or primary solid tumor malignancy unless in remission for 5 years or more, received prior systemic treatment for unresectable or metastatic melanoma, received prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, anti-PD-L2 agent or oncolytic virus, or have hypersensitivity to GM-CSF. In terms of comorbidities, patients with a known history of, or any evidence of active, non-infectious pneumonitis, as well as those with known cardiac disease were ineligible to enroll in the study.
Ultimovacs reported, in the press release, that at the 1-year time point, the OS was high and showed consistency with a prior analysis. The OS rate was 90% in cohort 2 and 85% in cohort 1. The median progression-free survival (PFS) was not reached in either cohort at 12 months. Further, it was shown the disease in the treated patients either improved or remained stable during the study.1
“These latest results are compelling, and in line with the data presented at ASCO from the first group of patients in this study,” said Carlos de Sousa, CEO of Ultimovacs. “We will discuss these results further…on 20 August 2021. We also plan to share more detailed results of the study at a major clinical oncology meeting in 2022.”
The study of UV1 in combination with pembrolizumab for the treatment of metastatic melanoma is ongoing. Topline data from the 2-year follow-up of the study will be reported towards the end of 2021.
1. Ultimovacs announces further positive topline results from phase I UV1 cancer vaccine combination study in metastatic melanoma. News release. August 12, 2021. Accessed August 12, 2021. https://bit.ly/2VTy9IJ
2. UV1 vaccine with pembrolizumab for patients with unresectable or metastatic melanoma. Clinicaltrials.gov. Accessed August 12, 2021. https://bit.ly/3yIfePq