FDA grants fast track designation to UV1 for advanced melanoma
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The FDA granted fast track designation to UV1 in combination with checkpoint inhibitor therapy for treatment of unresectable or metastatic melanoma.
The designation applies to use of UV1 (Ultimovacs) — a universal cancer vaccine — in combination with pembrolizumab (Keytruda, Merck) or ipilimumab (Yervoy, Bristol Myers Squibb).
The FDA based the fast track designation on results of two phase 1 trials.
One trial evaluated UV1 in combination with pembrolizumab, an anti-PD-1 therapy, as first-line treatment for patients with advanced melanoma.
Researchers reported an objective response rate of 57%, with 30% of patients achieving complete response. Eighty percent of patients remained alive at 24 months.
A second trial assessed UV1 in combination with ipilimumab, an anti-CTLA-4 antibody. Researchers reported an ORR of 33%, with 50% of patients surviving 5 years.
The company is conducting four phase 2 trials to evaluate UV1 in combination with checkpoint inhibitors.
One trial is evaluating the agent in combination with nivolumab (Opdivo, Bristol Myers Squibb), a PD-1 immune checkpoint inhibitor, as first-line treatment for unresectable or advanced melanoma. The other trials are assessing UV1 plus checkpoint inhibitors for patients with ovarian cancer, head and neck squamous cell carcinoma, or malignant pleural mesothelioma.
“We are delighted UV1 has received the fast track designation and look forward to working more closely with the FDA to bring UV1 to [patients with melanoma] as soon as possible,” Carlos de Sousa, CEO of Ultimovacs, said in a company-issued press release. “The FDA’s decision recognizes the potential synergy of UV1 and checkpoint inhibitors and will greatly encourage physicians and patients involved in our phase 2 clinical trial INITIUM. We remain committed to progressing UV1 in our four ongoing phase 2 clinical studies.”
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