ONYX-015 Appears Promising in Advanced Head and Neck Cancer

LOS ANGELES--A genetically engineered adenovirus that replicates in and kills tumor cells deficient in p53 tumor suppressor gene activity has shown promising results in patients with advanced head and neck cancer, David H. Kirn, MD, said at an ASCO poster session. Dr. Kirn is director of clinical research at Onyx Pharmaceuticals, Richmond, California, which is developing the new agent, known as ONYX-015.

In an ongoing phase II study, a combination of ONYX-015, cisplatin (Platinol), and fluorouracil produced objective clinical responses in 9 of 10 patients with recurrent head and neck cancer, including two complete re-sponses. Seven patients had a partial response (50% to 95% reduction in tumor mass), and the remaining patient had a 40% tumor regression.

Dr. Kirn pointed out that the average overall response rate with cisplatin and fluorouracil alone is about 35% historically in patients with recurrent disease.