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ARTICLE | Clinical News

GV1001: Phase III data

June 10, 2013 7:00 AM UTC

The open-label, U.K. Phase III TeloVac trial in 1,062 patients with advanced and metastatic pancreatic cancer showed that both concurrent and sequential administrations of GV1001 plus standard of care (SOC) of gemcitabine and capecitabine missed the primary endpoint of improving OS vs. SOC alone. Specifically, GV1001 given concurrently with SOC led to a median OS of 8.36 months (p=0.6378), while GV1001 given sequentially following 8-week SOC treatment led to a median OS of 6.94 months (p=0.0466) vs. 7.89 months for SOC alone. The Kael-Gemvax Co. Ltd subsidiary of GemVax & Kael said that the threshold for statistical significance was p<0.0175. Additionally, 12-month OS rates were 32.3% for GV1001 given concurrently with SOC, 25.3% for GV1001 given sequentially after SOC and 33.7% for SOC alone. ORRs were 15.5% in patients receiving GV1001 concurrently with SOC (p=0.46) and 8.9% in patients receiving GV1001 sequentially after SOC (p=0.001) vs. 17.6% in patients receiving SOC alone. The company said GV1001 was well tolerated "without significant side effects." Kael-GemVax said it identified 2 potential biomarkers that may predict an increased survival response in a subgroup of patients, but did not disclose details. The company said the data are "sufficiently strong to initiate new basic research into the mechanisms of action of the vaccine and test the use of GV1001 in future clinical trials" in a subgroup of patients using the biomarkers. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...