RICHMOND, CALIF. (Monday, May 18, 1998) --- Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) today reported results from two Phase II studies of its lead anticancer viral therapeutic, ONYX-015, in patients with tumors of the head and neck. In an ongoing Phase II study combining ONYX-015 with standard chemotherapy, the company reported that nine out of ten patients with recurrent tumors have experienced tumor regressions of greater than 50 percent to date, with two patients experiencing complete responses. In addition, the company reported that 30 percent of patients treated with ONYX-015 alone had significant tumor regressions, including two complete regressions in patients with end-stage, treatment-resistant disease.
During a poster session today at the American Society of Clinical Oncology (ASCO) meeting in Los Angeles, Onyx presented interim results from a Phase II trial combining ONYX-015 with Cisplatin and 5-FU, two standard chemotherapeutic agents used in the treatment of head and neck cancers. In addition to the two patients who had complete responses, seven patients experienced between 50 and 95 percent reductions in tumor mass. The one remaining patient has experienced a 40 percent tumor regression. To date, all of the patients continue on treatment with no evidence of disease progression. The average overall response rate with Cisplatin and 5-FU alone is about 35 percent historically in patients with recurrent disease,noted David H. Kirn, M.D., director of clinical research at Onyx.
"We have seen significant tumor regression in the patients treated to date, including some complete responses, and this is a dramatic early finding," Dr. Kirn said. "But we have only evaluated ten patients at this point. While we are encouraged by these initial results, we remain cautiously optimistic."
"Of course, because this is an ongoing study, we do not yet have information
regarding durability of responses. We will be able to discuss
these findings with gre
Contact: Joan Kureczka