FDA Fast Tracks UV1 Vaccine Combo for Mesothelioma

Research & Clinical Trials

The U.S. Food and Drug Administration granted fast-track designation to a new therapeutic cancer vaccine. The approval is for UV1 in combination with the immunotherapy drugs Opdivo (nivolumab) and Yervoy (ipilimumab) to manage malignant pleural mesothelioma that can’t be managed with surgery. 

Therapeutic cancer vaccines, unlike preventive vaccines, treat existing cancers. Fast Track expedites the development of drug reviews for severe conditions. This way, the FDA can bring essential new drugs to patients earlier. With this designation, UV1 drug-maker Ultimovacs ASA will interact more frequently with the FDA during the vaccine’s development. 

The phase II Nivolumab and Ipilimumab Plus/minus UV1 vaccination (NIPU) trial provided supporting data for the designation. Carlos de Sousa, chief executive officer at Ultimovacs, said of the trial in a press release: “The results from the first randomized UV1 phase 2 trial, NIPU…is a proof of concept for UV1.”

“UV1 demonstrated a positive safety profile,” de Sousa noted. “It showed encouraging signs of improvement in overall survival in combination with the checkpoint inhibitors, ipilimumab, and nivolumab, in malignant mesothelioma, a hard-to-treat cancer indication with significant unmet need.”

Improved Survival Led to Fast Track Designation

During the NIPU trial, 118 pleural mesothelioma patients randomly received 1 of 2 treatments. The first group received Opdivo at 240 mg every 2 weeks plus Yervoy at 1 mg/kg every 6 weeks. The others received the same combination of immunotherapy drugs and 8 intradermal injections of UV1 during the first 3 months of study treatment.

According to a press release from Ultimovacs ASA, the vaccine developer, the indication includes the vaccine-based combination as a treatment for those in the first-line setting. Patients in the first-line settings have a new mesothelioma diagnosis or have not received any prior treatment. 

Findings from the NIPU trial were presented as part of a late-breaking abstract at the 2023 European Society for Medical Oncology Congress. With a median follow-up of 17.3 months, the median overall survival with UV1 plus Opdivo and Yervoy was 15.4 months.

Researchers compared these results with a median survival of 11.1 months in patients who only received Opdivo and Yervoy alone. The overall survival improvement observed with the vaccine-based combination was statistically significant.

Treatment in the UV1 group produced a median progression-free survival of 4.2 months versus 2.9 months in the non-UV1 group. Patients who received UV1 had an objective response rate of 31% compared to 16% in the group that didn’t receive the mesothelioma vaccine.

Investigators reported that the rates of adverse effects were comparable between the treatment groups. “These data reaffirm our unwavering commitment to developing UV1 as an effective add-on treatment to checkpoint inhibitors for a range of cancers,” de Sousa said. 

UV1 Previously Granted Orphan Drug Designation

The FDA designated UV1 as an orphan drug treatment for those with mesothelioma. The designation was based on findings from the NIPU trial in October 2023. 

Orphan drugs are experimental medications used to treat rare medical conditions. Because these conditions affect few patients, these drugs involve government assistance during development. 

“We expect to announce topline results from our randomized phase 2 trial INITIUM in the coming month of March, and we look forward to reporting important data from our broad UV1 phase 2 clinical trial program with UV1 over 2024 and beyond,” de Sousa said in the press release.

“We eagerly anticipate the forthcoming results from our other ongoing phase 2 trials and how these data will move us forward in our mission to improve outcomes for [patients with] cancer worldwide,” de Sousa added.

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