A controlled trial of intratumoral ONYX-015, a selectively-replicating adenovirus, in combination with cisplatin and 5-fluorouracil in patients with recurrent head and neck cancer

ONYX-015 is an adenovirus with the E1B 55-kDa gene deleted, engineered to s electively replicate in and lyse p53-deficient cancer cells while sparing n ormal cells. Although ONYX-015 and chemotherapy have demonstrated anti-tumo ral activity in patients with recurrent head and neck cancer, disease recur s rapidly with either therapy alone. We undertook a phase II trial of a com bination of intratumoral ONYX-015 injection with cisplatin and 5-fluorourac il in patients with recurrent squamous cell cancer of the head and neck. Th ere were substantial objective responses, including a high proportion of co mplete responses. By 6 months, none of the responding tumors had progressed , whereas all non-injected tumors treated with chemotherapy alone had progr essed. The toxic effects that occurred were acceptable. Tumor biopsies obta ined after treatment showed tumor-selective viral replication and necrosis induction.