Trial of vaccine plus pembrolizumab for head/neck cancer misses endpoint
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The addition of an investigational cancer vaccine to pembrolizumab failed to improve outcomes for patients with metastatic or recurrent head and neck squamous cell carcinoma, according to the agent’s manufacturer.
UV1 (Ultimovacs) is designed to induce a specific T-cell response against telomerase.
Researchers conducted the randomized phase 2 FOCUS trial to assess the addition of the vaccine to pembrolizumab (Keytruda, Merck) — a PD-1 inhibitor — as a first-line treatment for metastatic HNSCC or as a second-line treatment of recurrent PD-L1-positive disease.
The trial included 75 patients. Fifty received the combination and 25 received pembrolizumab monotherapy.
PFS at 6 months after first administration of the vaccine served as the primary endpoint.
Secondary endpoints included PFS, OS, objective response rate, duration of response and safety. Minimum follow-up was 1 year.
The trial failed to meet its primary or secondary endpoints. Researchers indicated the vaccine exhibited a favorable safety profile, with adverse events comparable between the investigational and control groups.
“We have implemented a broad phase 2 clinical development program testing our cancer vaccine in a range of different indications,” Carlos de Sousa, CEO of Ultimovacs, said in a company press release. “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.”
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