The multicentre, randomised phase 3 trial of Oncophage versus observation as adjuvant therapy in patients at high risk of recurrence after nephrectomy for renal-cell carcinoma (RCC) is the largest randomised study in RCC to date in the adjuvant setting.

"Phase 3 end-of-study results continue to underscore the significant potential benefit of Oncophage in a well defined, clinically and biologically relevant subset of patients who are the most appropriate candidates for cancer vaccines," said Christopher Wood, MD, associate professor of urology, M.D. Anderson Cancer Center, Houston, Texas, United States. "In addition, there are no currently approved therapies for these patients, which represent a growing and significant population due to increased use of early-detection techniques."

Oncophage demonstrated a clinically significant improvement in the primary endpoint of recurrence-free survival (RFS) of approximately 45% (P <.01; hazard ratio [HR] = 0.55) in a substantial subset of patients (n = 362) at intermediate risk for disease recurrence. An updated analysis in this group of patients revealed that for intermediate-risk patients, there was a trend towards improved overall survival, the study's secondary endpoint.

The study's earlier analysis has been strengthened by updated data from an additional 17-month follow-up of patients.

Although the median survival has not yet been reached, results from the 25^th percentile indicate that in the Oncophage arm of the trial, RFS was extended by approximately 1.8 years.

Adverse effects reported during the trial were expected and generally mild.

A global patient registry is being initiated to continue collecting data on all patients from the trial for RFS and overall survival. The registry will follow patients for an additional 3 years from closure of the initial trial (March 31, 2007), and will provide more than 5 years worth of data collection.

Antigenics Inc. of New York, New York, United States, maker of Oncophage, intends to seek a meeting with the U.S. Food and Drug Administration to discuss the results of the updated analyses utilising data through March 2007 to determine if there is an opportunity to file a biologics license application on the basis of these results, along with appropriate commitments to conduct further clinical investigations to support the efficacy of Oncophage in RCC.


[Presentation title: A Multicenter, Randomized, Phase 3 Trial of a Novel Autologous Therapeutic Vaccine (Vitespen) Versus Observation as Adjuvant Therapy in Patients at High Risk of Recurrence After Nephrectomy for Renal Cell Carcinoma. Abstract 633]

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