Antigenics Provides Update on Oncophage Filing in Russia

Antigenics announced that it has completed the submission of an application for marketing authorization with the Russian Ministry of Public Health for the use of Oncophage in the treatment of kidney cancer patients at intermediate risk for disease recurrence.

Garo Armen, chairman and CEO of Antigentics, said the company is hoping to make Oncophage (vitespen) available in Europe, Canada and the U.S.

Antigenics said its filing with the Russian Ministry of Public Health contains final investigator-reported results from the largest, randomized, Phase III kidney cancer trial ever completed in the adjuvant treatment setting.

In the study, 604 eligible patients who were without renal cell carcinoma disease at baseline were randomized at 118 centers worldwide, including 172 patients (28 percent) at eight sites in Russia, the company added.

According to the company, results from investigator-reported data showed that patients receiving Oncophage in the intermediate-risk population (stages I/II high-grade, III T1/2/3a low-grade) who were without disease at baseline demonstrated a clinically significant improvement in recurrence-free survival of approximately 45 percent.

Although the median has not yet been reached, results from the 25th percentile indicate that recurrence-free survival was extended by approximately 1.8 years, the company added.