If bavituximab truly doubles lung-cancer survival in the second-line setting, the drug should demonstrate a similar benefit in the front line.
Peregrine's first-line lung cancer study also enrolled roughly half its patients from Eastern Europe and India, so the same need to show geographic consistency applies.
A previously reported single-arm study of bavituximab plus carboplatin/paclitaxel in 49 first-line lung cancer patients -- all recruited from India -- reported an overall response rate of 43%, median progression-free survival of 6.1 months and a median overall survival of 12.4 months.
Comparing across trials is problematic, but it does seem strange that bavituximab is producing a lung cancer survival benefit in the second line (12.1 months) equivalent to the first line (12.4 months). One possible explanation, of course, is that the patients enrolled in the second-line study presented Friday aren't really second-line patients.
One more question regarding bavituximab's purported mechanism of action: If the drug is indeed an immune-stimulatory anticancer drug, shouldn't there be clinical data related to immune response and/or associated toxicity? I can't recall seeing any such data.
Peregrine is holding a conference call Monday morning to discuss Friday's bavituximab data. Peregrine shares closed Friday up $1.43, or 47%, to $4.50.
-- Written by Adam Feuerstein in Boston
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