Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have announced positive results from their DECISION trial of Nexavar (sorafenib) in patients with thyroid cancer.
The Phase III trial has met the primary endpoint of improving progression-free survival in patients with radioactive iodine refractory differentiated thyroid cancer.
Bayer HealthCare global clinical development oncology vice president Dr Dimitris Voliotis said the results demonstrate Nexavar's activity in RAI-refractory locally advanced, or metastatic differentiated thyroid cancer patients.
"These types of thyroid cancer are difficult to treat and are associated with a poor prognosis," Voliotis said.
The multicentre, randomised study was designed to analyse the efficacy and safety of Nexavar compared to placebo in thyroid cancer patients who had received no earlier chemotherapy, tyrosine kinase inhibitors, or monoclonal antibodies against the disease.
The placebo-controlled study randomised 417 patients with locally advanced or metastatic, radioactive iodine-refractory, differentiated thyroid cancer with 400mg of oral Nexavar twice daily or matching placebo.
The primary endpoint was progression-free survival while the secondary endpoints included overall survival, time to progression, response rate and duration of response.
Study data is expected to form the basis for regulatory submission of Nexavar in treating RAI-refractory differentiated thyroid cancer.
Onyx clinical development senior vice president Dr Barbara Klencke said; "Effective treatment options are urgently needed for patients with radioactive iodine-refractory differentiated thyroid cancer."