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Bayer-Onyx DECISION trial of Nexavar meets primary endpoint

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have announced that the stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer (DECISION) trial of Nexavar (sorafenib) met the primary endpoint.

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.