Ultimovacs announced three-year survival data from its second cohort of UV1-103 Phase I clinical trial in combination with an anti-PD-1 checkpoint inhibitor, Keytruda (pembrolizumab), in patients with malignant melanoma.

Ultimovacs chief medical officer Jens Bjørheim said: “We are very encouraged to observe a 67% overall survival rate at a three-year follow-up in this Phase I study, which treats the same patient population as our UV1 Phase II study, INITIUM.”

The US-based company has completed patient recruitment for the Phase II INITIUM clinical trial (NCT04382664) of UV1 combined with Bristol-Myers Squibb’s monoclonal antibody combination of Yervoy (ipilimumab) and Opdivo (nivolumab), to treat metastatic malignant melanoma. The result readout is expected in the second half of 2023.

Yervoy, Opdivo, and Keytruda have received FDA approval for several cancer indications, including unresectable or metastatic melanoma.

GlobalData forecasts therapeutic cancer vaccines as the weakest immune-oncology agent class with relatively low global sales of up to $4bn by 2028, compared to checkpoint modulators sales reaching $120bn by 2028.

GlobalData is the parent company of Clinical Trials Arena.

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By GlobalData

UV1-103 + Keytruda trial data

This US-based open-label Phase I clinical trial (NCT03538314) is evaluating UV1-103, in combination with Keytruda, as first-line treatment in patients with unresectable metastatic malignant melanoma.

A total of 30 patients in the US were treated in the study in two cohorts that differed only in the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF) used as the vaccine adjuvant. The first cohort of 20 patients received a 37.5 mcg GM-CSF adjuvant dose per UV1 vaccination while the second cohort of ten patients received the standard 75mcg GM-CSF adjuvant dose per UV1 vaccination.

Out of the 30 patients treated, 27 were analysed for long-term monitoring after two years. Of these, 18 patients remained alive at the three-year mark, with 12 of 17 patients and six of ten patients surviving in cohorts one and two, respectively.

57% of the patients reported complete or partial disappearance of tumours, with complete disappearance in 33% of the patient population, according to Ultimovacs’ previous report.