Antigenics (AGEN) Reports Positive Oncophage(R) Interim Survival Data at ASCO

June 1, 2009 9:08 AM EDT

Antigenics Inc. (NASDAQ: AGEN) today announced results of an interim analysis from the company's ongoing global patient survival registry, which showed that patients with kidney cancer at intermediate risk of disease recurrence demonstrated an approximately 46 percent lower risk of death when treated with Oncophage(R) (vitespen) cancer vaccine compared with observation (n = 362; P = 0.036; hazard ratio [HR] = 0.54).

The interim analysis from the patient registry, INSPIRE (International Survival Follow-up Registry of Patients Previously Enrolled In the Renal Cell Carcinoma Evaluation of Adjuvant Oncophage Treatment), reflects a median follow-up of 4.5 years from the largest, randomized Phase 3 kidney cancer trial ever completed to date in the adjuvant setting. The patient registry was launched in order to confirm encouraging overall survival trends observed from the Phase 3 non-metastatic kidney cancer study. Final results from INSPIRE are expected mid 2010. The interim results show that:

• Patients receiving Oncophage in the intermediate-risk population (American Joint Committee on Cancer [AJCC] stages I/II high-grade, III T1/2/3a low-grade) had a lowered risk of death by approximately 46 percent (n = 362; P= 0.036; HR = 0.54). As of the data cutoff on January 5, 2009, the total reported deaths in the intermediate-risk population are 18 deaths (9.8 percent) in the Oncophage arm compared with 32 deaths (18 percent) in the observation arm.
  
• The results currently show a survival advantage in earlier-stage patients (AJCC stages I/II high grade) receiving Oncophage, with a reduction in the risk of death by approximately 37 percent (n = 184; HR = 0.63). From March 2007 to January 2009, only one death was reported in the Oncophage arm versus four in the observation arm, bringing the total reported deaths to 13 (10.4 percent) in the Oncophage arm compared with 20 (17.4 percent) in the observation arm.
  
• In addition, there was a promising trend for overall survival in patients treated with Oncophage in the total population eligible for the study, which included intermediate and high-risk patients (n = 604; HR = 0.81). As of the January 5, 2009 data cutoff, 18 additional deaths have been reported, with seven in the Oncophage arm and 11 in the observation arm, bringing the total to 44 (14.7 percent) and 51 (16.8 percent) deaths, respectively.
  
• Median survival has yet to be reached in these patient populations.

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