Phase 3 Nexavar DECISION trial has demonstrated the improvement in progression-free survival in radioactive iodine refractory differentiated thyroid cancer patients.
Bayer HealthCare global clinical development oncology vice president 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 added.
The multicentre, randomised study was conducted in thyroid cancer patients who did not receive earlier chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies against the disease.
A total of 417 patients with locally advanced or metastatic, radioactive iodine-refractory, differentiated thyroid cancer were randomized with 400mg of oral Nexavar twice daily or matching placebo.
Primary endpoint of the placebo-controlled study was progression-free survival while the secondary endpoints comprised overall survival, time to progression, response rate and duration of response.