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Phase 3 DECISION Trial Investigating The Use Of Nexavar® (sorafenib) Demonstrated Significant Improvement In Progression-Free Survival In Patients With Radioactive Iodine-Refractory Differentiated Thyroid Cancer

WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., June 2, 2013 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced positive results from the Phase 3 DECISION trial investigating the use of Nexavar ® (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. These data will be presented in a plenary session on June 2, 2013, at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL at 3:20pm CDT (Abstract #4).

Sorafenib significantly extended progression-free survival (PFS), the primary endpoint of the study, compared to placebo. The median PFS was 10.8 months among patients treated with sorafenib, compared to 5.8 months among patients receiving placebo (HR=0.587 [95% CI, 0.454-0.758]; p<0.0001). PFS was evaluated by an independent radiological review committee using Response Evaluation Criteria in Solid Tumors (RECIST). Safety and tolerability in the study were generally consistent with the known profile of sorafenib.

At the time of progression, patients had the option to cross over to open-label sorafenib at the discretion of the investigator; 71% of patients in the placebo arm received open-label sorafenib after progression; 27% of patients in the sorafenib arm received open-label sorafenib after progression.

There was no statistically significant difference in overall survival between the treatment arms (HR=0.802 [95% CI, 0.539-1.194]; p=0.138), a secondary endpoint of the trial. Median overall survival has not yet been reached in either arm.

The most common treatment-emergent adverse events across all grades occurring in >20% of patients taking sorafenib vs. placebo were hand-foot skin reaction (76.3% vs. 9.6%), diarrhea (68.6% vs. 15.3%), alopecia (67.1% vs. 7.7%), rash/desquamation (50.2% vs. 11.5%), fatigue (49.8% vs. 29.4%), weight loss (46.9% vs. 13.9%) hypertension (40.6% vs. 12.4), metabolic/laboratory (35.7% vs. 16.7%), anorexia (31.9% vs. 4.8%),oral mucositis (23.2% vs. 3.3%), pruritis (21.3% and 10.5%) and nausea (20.8% and 11.5%).  Treatment-emergent adverse events led to discontinuation in 18.8% of patients who received sorafenib, compared to 3.8% of patients who received placebo.

"While most patients with differentiated thyroid cancer are cured, there is a major treatment gap for patients whose cancer no longer responds to standard therapies," said Marcia Brose, M.D., Ph.D., principal investigator of the DECISION trial and Assistant Professor in the Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania. "The DECISION results demonstrate sorafenib's ability to extend progression-free survival compared to placebo in these patients, potentially providing a new treatment option for these patients."

"This trial is representative of our continued commitment to fully understanding sorafenib's potential applicability, especially in hard-to-treat cancers where there are limited treatment options," said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

"In the past 30 years, there have been no new treatment options approved for patients with radioactive iodine-refractory differentiated thyroid cancer," said Pablo J. Cagnoni, M.D., Executive Vice President, Global Research & Development and Technical Operations, Onyx Pharmaceuticals. "We are pleased with the results of the DECISION study, which demonstrate sorafenib's activity in patients who have no other treatment options."

The Phase 3 DECISION data will form the basis for regulatory submissions of sorafenib for the treatment of RAI-refractory differentiated thyroid cancer. Submission of a supplemental New Drug Application (sNDA) in the United States is planned for mid-year 2013, with additional submissions to follow globally.

DECISION Trial DesignThe DECISION (stu Dy of soraf Enib in lo Cally advanced or metastat Ic patient S with radioactive Iodine refractory thyr Oid ca Ncer) trial was an international, multicenter, placebo-controlled study. A total of 417 patients with locally advanced or metastatic, RAI-refractory, differentiated thyroid cancer (papillary, follicular, Hurthle cell and poorly differentiated) who had received no prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptor, or other targeted agents for thyroid cancer were randomized to receive 400 mg of oral sorafenib twice daily (207 patients) or matching placebo (210 patients). Ninety-six percent of randomized patients had metastatic disease.

The primary endpoint of the study was progression-free survival, as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints included overall survival, time to progression, response rate and duration of response. Safety and tolerability were also evaluated.

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