Last year, a phase III trial demonstrated Nexavar (sorafenib) tablets significantly extended progression-free survival in locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment.
Results from the trial, named DECISION, were recently published in The Lancet. Based on these data, Nexavar was approved by FDA in November 2013.
“The Lancet publication will give healthcare providers greater insight into the DECISION trial,” said Marcia Brose, principal investigator of the 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.”
The 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. Secondary endpoints included overall survival, 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). Following investigator-determined disease progression, 157 (75 percent) patients randomized to placebo crossed over to open-label Nexavar, and 61 (30 percent) patients randomized to Nexavar received open-label Nexavar.
Nexavar is also approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma, patients with advanced renal cell carcinoma. Nexavar is thought to inhibit both the tumor cell and tumor vasculature. In in vitro studies, Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation and angiogenesis. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Nexavar is sponsored by Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals Inc., an Amgen subsidiary.
