Dr. Cohen on the Rationale of the Active8 Study in SCCHN

Ezra Cohen, MD, professor of medicine, UC San Diego Moores Cancer Center, discusses the rationale of the Active8 study.

This study is evaluating VTX-2337, a novel Toll-like receptor 8 (TLR8) agonist, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). This study was conducted because TLR8 can activate immune effector cells, the agent can be administered with cetuximab, and it potentiates other cytotoxic chemotherapy agents. It was thought that the best setting for this agent would be in combination with a regimen that employed platinum and cetuximab.

In this phase II, randomized, double blind study, VTX-2337 was combined with the EXTREME regimen. The endpoint of the study was progression-free survival by immune RECIST criteria.

Cohen says it is intriguing that VTX-2337 does not appear to add any toxicity to the EXTREME regimen. For the first time ever with this trial, immunotherapy is being integrated into an active regimen in SCCHN.