Antigenics presents data showing Oncophage vaccine extends patients' lives

New York, June 5 - Antigenics Inc. reported that its investigational cancer vaccine Oncophage (vitespen, formerly HSPPC-96) extended the survival time of patients with metastatic melanoma in a phase 3 clinical trial.

Patients who received at least 10 doses of vaccine experienced an extension in median survival of 29% compared with those who received physician's choice, the company said.

In a subset analysis, Oncophage was associated with a potentially clinically relevant benefit compared with physician's choice for patients with stages IV M1a and M1b melanoma, if at least 10 doses of vaccine were administered.

"This is the first time a cancer vaccine has shown evidence of a potential survival benefit in this patient population," Jon Richards of the oncology-hematology department at Lutheran General Cancer Care Center in Park Ridge, Ill., and lead investigator of the study, said in a news release. "These findings are consistent with preclinical and early clinical research conducted to date and lay a solid foundation for the continued exploration of Oncophage vaccine in better-prognosis stage IV melanoma patients."

The phase 3 trial included 322 patients with stage IV melanoma in two treatment arms: Oncophage or physician's choice, in a 2:1 ratio favoring Oncophage, and prospectively stratified based on AJCC metastatic stage (M1a, M1b, M1c). Physician's choice included interleukin 2 and/or dacarbazine-/temozolomide-based therapy and/or complete tumor resection, and could also include any other licensed treatments for cancer.

The primary endpoint of the trial was overall survival, and comparison of survival data was made using the Kaplan-Meier method (an estimate of the cumulative probability of survival for a set of data) and a one-sided log-rank test.

Overall, in the intent-to-treat analysis, patients in the Oncophage arm (M1a, -b and -c combined) fared similarly to those in the physician's choice arm in terms of survival (9.4 months versus 10.7 months, respectively).

Researchers also found that patients who received at least 10 doses of vaccine (44 patients) experienced an extension in median survival of 29% compared with those who received the physician's choice (72 patients; 16.5 months versus 12.8 months, respectively).

A more pronounced effect was observed in M1a and M1b patients who received at least 10 vaccines (25 patients) compared with those who received the physician's choice (33 patients), with an improved survival of 31.2 months versus 12.8 months, respectively.

Adverse events reported during the trial were generally mild and expected, Antigenics said.

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

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