Phase 3 DECISION Trial Of NexavarÂ® (sorafenib) Meets Primary Endpoint Of Improving Progression-Free Survival In Patients With Radioactive Iodine Refractory Differentiated Thyroid Cancer
WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., Jan. 3, 2013 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that a Phase 3 trial of Nexavar ® (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer has met its primary endpoint of a statistically significant improvement of progression-free survival. The study, called DECISION, evaluated the efficacy and safety of Nexavar compared to placebo. Adverse events were generally consistent with the known profile for Nexavar. Data from this study are expected to be presented at an upcoming medical meeting.
"These results demonstrate Nexavar's activity in patients with RAI-refractory locally advanced, or metastatic differentiated thyroid cancer," said Dimitris Voliotis, M.D., Vice President, Global Clinical Development Oncology, Bayer HealthCare. "These types of thyroid cancer are difficult to treat and are associated with a poor prognosis."
"Effective treatment options are urgently needed for patients with radioactive iodine-refractory differentiated thyroid cancer," said Barbara Klencke, M.D., Senior Vice President, Clinical Development at Onyx Pharmaceuticals. "We are pleased that the results of this study demonstrate that Nexavar may provide a treatment option for these patients."
The companies anticipate that this data will form the basis for regulatory submission of Nexavar in the treatment of RAI-refractory differentiated thyroid cancer.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, randomized, placebo-controlled study that randomized 417 patients with locally advanced or metastatic, radioactive iodine-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. Patients were randomized to receive 400 mg of oral Nexavar twice daily or matching placebo. At the time of progression, patients receiving placebo had the option to cross over to Nexavar at the discretion of the investigator, based on the patient's clinical status. 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. About Thyroid Cancer Thyroid cancer, one of the few cancers that has increased in incidence over the past several years, is the sixth most common cancer in women, with about three times as many women as men diagnosed. There are more than 160,000 new cases of thyroid cancer and approximately 25,000 people die worldwide each year.
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