Antigenics phase 3 study of kidney cancer patients fails to meet endpoints

By Elaine Rigoli

Tampa, Fla., March 24 - Antigenics, Inc. announced the results from its phase 3 study of Oncophage (vitespen) in kidney cancer patients who are at high risk of recurrence after surgery.

The analysis was triggered based on the number of events (defined as recurrence of disease or death of a patient prior to recurrence) reported by study investigators, according to a company news release.

However, an independent review by the trial's Clinical Events Committee (CEC) revealed that a substantially smaller number of events had actually occurred, the release said.

The analysis showed a trend in favor of Oncophage for recurrence-free survival - the study's primary endpoint - and a trend against Oncophage for overall survival- the secondary endpoint; both findings were not statistically significant, the release said.

The results of the CEC review revealed that the required number of events to conduct analysis of the recurrence-free survival endpoint was not met. The analysis of the overall survival endpoint is considered an interim assessment.

Antigenics said it is continuing to conduct a thorough review of the safety and efficacy data and plans to meet with the Food and Drug Administration at the end of April to discuss the findings from this trial.

The randomized, international, multicenter, open-label trial (C-100-12) involved 728 eligible patients whose renal cell carcinoma was at high risk of recurrence after nephrectomy, the surgical removal of the diseased kidney.

Patients were randomized in a 1:1 ratio into two arms: nephrectomy plus Oncophage vaccination (treatment arm) or nephrectomy alone (observation arm). The arms were well-balanced for all known prognostic factors, the release said.

Although the study protocol required that eligible patients be free of disease at baseline, an independent review by the CEC subsequently found that of the 728 patients enrolled in the trial, 124 had disease at baseline, the release said.

Further, of the 218 events reported by investigators, 92 of these occurred in patients who had metastatic or residual disease at baseline. These patients should have been deemed ineligible for the trial.

Antigenics said it will suspend part 2 of the kidney cancer trial until data from part 1 are fully analyzed.

New York City-based Antigenics is a biotechnology company working to develop treatments for cancers, infectious diseases and autoimmune disorders.

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