Onyx Pharmaceuticals Reports Promising Results for Anticancer Treatment ONYX-015

Richmond, Calif., May 18, 1998 - Onyx Pharmaceuticals, Inc. announced promising results from two Phase II studies of its lead anticancer viral therapeutic, ONYX-015, in patients with tumors of the head and neck. The company reported that nine out of ten patients with recurrent tumors have experienced tumor regressions of greater than 50 percent, 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.

Key Takeaways:

  • Nine out of ten patients with recurrent tumors have experienced tumor regressions of greater than 50 percent, with two patients experiencing complete responses.
  • 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.
  • The combination of ONYX-015 with standard chemotherapy, Cisplatin and 5-FU, resulted in seven patients experiencing between 50 and 95 percent reductions in tumor mass, with two patients achieving complete responses.
  • Patients treated with ONYX-015 showed no evidence of disease progression to date, with the average overall response rate with Cisplatin and 5-FU alone being about 35 percent historically in patients with recurrent disease.
  • The company is cautiously optimistic about the results, but notes that durability of responses is still unknown and requires further evaluation in a larger number of patients over a longer follow-up period.
  • Onyx initiated the Phase II, single agent intensive regimen trial in March of this year, and all Phase II studies of ONYX-015 in head and neck cancer are expected to be completed before the end of 1998.

Sources:

  • Onyx Pharmaceuticals, Inc. - May 18, 1998
  • American Society of Clinical Oncology (ASCO) meeting in Los Angeles

Statistics:

  • 9/10 patients with recurrent tumors experienced tumor regressions of greater than 50 percent.
  • 30% of patients treated with ONYX-015 alone had significant tumor regressions.
  • 7/10 patients treated with ONYX-015 and Cisplatin/5-FU experienced between 50-95% reductions in tumor mass.
  • 2/10 patients achieved complete responses with ONYX-015 and Cisplatin/5-FU.
  • 35% is the average overall response rate with Cisplatin and 5-FU alone in patients with recurrent disease.