One-year survival was 88% and two-year survival was 76%, with a mean follow-up of approximately 24 months. These results compare favorably with historical data from multiple studies in patients undergoing pancreatic cancer surgery and adjuvant therapy for whom the two-year survival has been reported to be in the range of 40% to 50%.
In the trial, patients received up to five vaccine treatments – the first prior to adjuvant therapy, the next three following adjuvant therapy at approximately one-month intervals and the fifth as a booster injection six-months later. Patients were monitored for evidence of relapse and survival, as well as the occurrence of adverse events.
“We are certainly encouraged by the initial results of this phase II study with respect to the two-year survival data compared to previously reported results for surgery and adjuvant therapy of resectable pancreatic cancer,” said Dr Joseph Vallner, president and COO of Cell Genesys. “Based on these findings, we plan to discuss with the Food and Drug Administration a potential registration strategy for GVAX vaccine for pancreatic cancer.”