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Phase 3 DECISION Trial Of NEXAVAR (sorafenib) In Locally Recurrent Or Metastatic, Progressive, Differentiated Thyroid Cancer Refractory To Radioactive Iodine Published In The Lancet

WHIPPANY, N.J. and THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., April 23, 2014 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc., an Amgen subsidiary (Nasdaq: AMGN), today announced that The Lancet published online results from the Phase 3 DECISION trial which demonstrated that NEXAVAR ® (sorafenib) tablets significantly extended the time patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment lived without their disease worsening (progression-free survival; PFS). 

Based on these data, NEXAVAR was approved by the U.S. Food and Drug Administration (FDA) in November 2013 for patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment. These patients previously had limited approved treatment options.

"The Lancet publication will give healthcare providers greater insight into the DECISION trial. While the majority of differentiated thyroid cancers are treatable, patients who are no longer responding to standard therapies - including surgery and radioactive iodine - are more difficult to treat and have limited options," said Marcia Brose, M.D., Ph.D., principal investigator of the DECISION trial and Assistant Professor in the Department of Otorhinolaryngology: Head and Neck Surgery in the Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania. "The DECISION trial demonstrates the activity of sorafenib for this type of differentiated thyroid cancer in patients with this challenging tumor."   

About the DECISION Trial The 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 that evaluated 417 patients with locally recurrent or metastatic, progressive differentiated thyroid carcinoma refractory to radioactive iodine treatment.  The primary endpoint of the study was progression-free survival (PFS), or the length of time patients lived without their thyroid cancer worsening, and was evaluated by an independent radiological review using modified Response Evaluation Criteria in Solid Tumors (mRECIST). Secondary endpoints included overall survival (OS), tumor response rate, and duration of response. Safety and tolerability were also evaluated.  

Results were presented in a plenary session at the American Society of Clinical Oncology Annual Meeting in June 2013.

Median PFS was 10.8 months (95% CI 9.1-12.9) among patients treated with NEXAVAR, compared to 5.8 months (95% CI 5.3-7.8) among patients receiving placebo (HR=0.59 [95% CI, 0.46, 0.76]; p<0.001).  There was no statistically significant difference in overall survival (HR= 0.80 [95% CI, 0.54–1.19]; p=0.14), a secondary endpoint of the trial.  Following investigator-determined disease progression, 157 (75%) patients randomized to placebo crossed over to open-label NEXAVAR, and 61 (30%) patients randomized to NEXAVAR received open-label NEXAVAR.

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