) -- This week's Biotech Stock Mailbag is open for business.
had a rough week, starting with the surprise and sudden resignation of R&D chief Sumant Ramachandra for "personal reasons." Ramachandra was hired in February so his exit just three months later is concerning, exacerbated by the presentation of ganetespib lung cancer data coming up next month at the ASCO annual meeting.
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Is there something wrong with the ganetespib data which prompted Ramachandra to leave Synta? We don't know, of course, but the question itself explains the stock's weakness this week.
Synta had previously told investors the analysis of the ganetespib lung cancer data would be conducted in May. Was it done before or after Ramachandra resigned? Synta IR guy George Farmer wouldn't say.
So, we wait for the presentation of the ganetespib lung cancer data, set for June 3 at the ASCO meeting.
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The phase II "Galaxy-1" study compares ganetespib plus docetaxel against docetaxel alone in second-line non-small cell lung cancer.
Synta last presented data from Galaxy-1 last fall. Here's what the overall survival curves looked like:
The hazard ratio is 0.688, which translates into a 31% reduction in the risk of death favoring ganetespib. This is only a trend and not statistically significant. At ASCO in June, we'll get an update on overall survival with the full complement of 254 patients enrolled in the study, followed for a median of 9 to 10 months (compared to six months in the chart above.)
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This is a bit weird, but Synta didn't wait for final data from Galaxy-1 before starting to enroll patients in a phase III study of ganetespib in second-line lung cancer. This larger Galaxy-2 study excludes patients who are deemed to be "rapid progressors" -- defined as patients who responded poorly to first-line therapy. In order to qualify for entry into Galaxy-2, patients have to be stable (no tumor growth) following first-line therapy for at least six months. Call these patients "normal progressors" for lack of a better term.
Also at ASCO next month, we'll see updated survival data from the subgroup of "normal progressors" enrolled in Galaxy-1. This is what the data looked like when presented last fall: