In a phase II study of 70 patients with advanced pancreatic cancer, the combination of bavituximab and gemcitabine prolonged survival by just 12 days over gemcitabine alone. Peregrine didn't disclose a p value for the survival analysis, so assume it was large and definitely not statistically significant.
Neither the 5.8 month median overall survival in the bavituximab-gemcitabine arm of Peregrine's phase II study nor 5.2 months in the gemcitabine arm was any better than the historical 5-6 month survival typically seen when pancreatic cancer patients are treated with gemcitabine alone.
In Celgene's (CELG) recent phase III study, which enrolled more than 800 patients, the combination of Abraxane plus gemcitabine yielded a median overall survival of 8.5 months compared to 6.7 months for gemcitabine alone.Overall survival was the primary endpoint of the bavituximab pancreatic cancer study, which dulls the clinical meaning of the response rate benefit touting by Peregrine in Wednesday's press release. Patients treated with bavituximab-gemcitabine had a 28% tumor response rate compared to 13% for patients treated with gemcitabine alone. Peregrine fails to note if the response rate difference was statistically significant, or if response rates were confirmed by independent review. Peregrine has a habit of releasing unverified response rate data from bavituximab studies, only to see those response rates nullified by independent review. And of course, Peregrine's credibility was shot when it was forced to rescind last year's bavituximab lung cancer data due to improper study conduct. In a statement Wednesday, Peregrine said it hoped to find subsets of pancreatic cancer patients where bavituximab may work better. Data mining negative study results is the last bastion of hope for desperate drug developers. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein
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