Cancer Vaccine UV1 Shows No Survival Benefit in Head and Neck Cancer

Adding UV1 to Keytruda did not improve survival outcomes in patients with head and neck cancer.

Adding the cancer vaccine, UV1, to Keytruda (pembrolizumab) did not result in clinical benefits regarding disease progression or survival among patients with metastatic or recurrent head and neck cancer.

In the phase 2 FOCUS trial, topline data showed that the addition of UV1 to the current standard of care of Keytruda as a first-line treatment in patients with metastatic cancer or as a second-line treatment for patients with recurrent PD-L1 positive head and neck squamous cell carcinoma (HNSCC) did not meet the study goal of progression-free survival (the time a patient lives without their disease spreading or worsening) at six months, according to a news release from UV1 manufacturer Ultimovacs.

UV1 also did not lead to an improvement in overall survival, which is defined as the time a patient lives regardless of disease status, according to the news release.

“We have implemented a broad phase 2 clinical development program testing our cancer vaccine in a range of different indications. Unfortunately, the FOCUS study did not provide us with the results we had hoped for, and we are disappointed that UV1 was not able to provide added clinical benefit for these HNSCC patients,” stated Carlos de Sousa, chief executive officer at Ultimovacs, in the news release.

Learn More: ‘More is Not Always Better’ in Chemoradiotherapy for Head and Neck Cancer

With approximately 75 patients at 10 sites across Germany, the FOCUS trial launched in August 2021, according to Ultimovacs and the trial’s listing on clinicaltrials.gov. All patients were followed up with for close to 12 months or longer to evaluate progression-free survival, overall survival and safety, according to the news release.

UV1, according to the National Cancer Institute, is a synthetic peptide vaccine intended to stimulate cytotoxic T cells to recognize and kill cells that express telomerase, an enzyme typically repressed in healthy cells and overexpressed in most cancer cells, playing a crucial role in cellular proliferation.

Under the current standard of care of immune checkpoint blockade therapy with or without chemotherapy, the median overall survival time for patients with metastatic or recurrent head and neck squamous cell carcinoma is less than 15 months, with many patients too frail to tolerate chemotherapy, according to the news release from Ultimovacs.

Learn More: What to Expect With a High Risk of Head and Neck Cancer Recurrence

UV1 Is currently being investigated for the treatment of ovarian cancer in the phase 2 DOVACC trial, according to the news release. The trial evaluates Lynparza (olaparib) and Imfinzi (durvalumab) with or without UV1 versus stand-alone Lynparza as a second-line maintenance treatment for patients with high-grade, BRCA-negative ovarian cancer, with topline results from that trial expected to be released in the first half of 2025, according to Ultimovacs.

“We are disappointed that the FOCUS trial did not achieve the desired outcome for patients, which underscores the complexities of treating metastatic and recurrent head and neck cancer,” said Jens Bjørheim, chief medical officer at Ultimovacs, in the news release. “This cancer type is particularly aggressive with limited treatment options and high rates of recurrence. Our broad clinical development program was designed to identify the best patient populations for UV1 and we are now focusing our efforts on the upcoming DOVACC data readout in the first half of next year.”

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