Cancer Vaccine Approved in Russia for Patients With Intermediate-Risk Renal Cell Carcinoma

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Title: Cancer Vaccine Approved in Russia for Patients With Intermediate-Risk Renal Cell Carcinoma
URL: http://www.pslgroup.com/dg/21F42E.htm
Doctor's Guide
April 8, 2008

NEW YORK and MOSCOW -- April 8, 2008 -- The Russian Ministry of Public Health has issued a registration certificate for the use of vitespen (Oncophage) in the treatment of patients with renal cell carcinoma who are at intermediate risk for disease recurrence.

Derived from each individual's tumour, vitespen contains the "antigenic fingerprint" of the patient's particular cancer and is designed to reprogram the body's immune system to target only cancer cells bearing this fingerprint. Vitespen is the first personalised cancer vaccine available in any major country, according to Antigenics Inc., maker of the vaccine. The company expects to launch vitespen in Russia in the second half of 2008.

"The current standard of care for patients with nonmetastatic renal cell carcinoma consists of surgical removal of the kidney followed by observation," commented Professor Vsevolod Matveev, N.N. Blokhin's National Cancer Research Center of RAMS, Moscow. "Following surgery, these patients often request treatment options to help prevent or delay recurrence of their disease. This registration means patients in Russia with earlier stage disease will now have [vitespen] as a treatment option."

Russian Ministry of Public Health registration was based on results from the largest, randomised, phase 3 renal cell carcinoma trial ever completed in the adjuvant treatment setting. The study included 604 patients from 118 centres worldwide who were without renal cell carcinoma disease at baseline; 28% of enrolled patients were participating at 1 of 8 sites in Russia. Patients were randomised to vitespen or to observation.

Findings from investigator-reported data showed that intermediate-risk patients, defined as stages I/II high-grade, III T1/2/3a low-grade, (n = 362) who received vitespen demonstrated a clinically significant improvement in recurrence-free survival of approximately 45% over patients in the observation arm (P < .01; hazard ratio = 0.55). Although the median has not yet been reached, results from the 25th percentile indicate that recurrence-free survival was extended by approximately 1.7 years.

The most common adverse events reported during the trial were generally mild and expected. The more frequently reported adverse events were mainly constitutional in nature or related to the actual injection, and included, but were not limited to, injection site erythema, injection site induration, injection site pain, injection site oedema, headache, fatigue, and rash.

The primary efficacy data supporting this application are currently being prepared for scientific publication.

Vitespen is not approved outside of Russia. The vaccine has received fast track and orphan drug designations from the US Food and Drug Administration for both renal cell carcinoma and metastatic melanoma. Vitespen has orphan drug status for renal cell carcinoma from the European Medicines Agency.

SOURCE: Antigenics Inc.

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