Asco: Masitin Entry

Topics: Pancreatic cancer, Post-hoc analysis, Subgroup analysis Pages: 4 (1038 words) Published: February 16, 2013
EvaluatePharma - AB Science’s silence goes to the heart of masitinib’s ap...

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AB Science’s silence goes to the heart of masitinib’s approvability Source Company Tags Date EP Vantage AB Science Comment, Free Content, Company Strategy, Trial Results, Oncology January 28, 2013

The ASCO-GI conference has come and gone, and still key questions remain unanswered about the apparently stellar result from last year’s phase III pancreatic cancer study of AB Science’s masitinib. The company had earlier stated that at ASCO-GI it would reveal details about the robustness of the post-hoc analysis and the genetic biomarker that seems to correlate strongly with masitinib’s efficacy. But it now says that these will not be disclosed until later – a remarkable level of secrecy given that masitinib is already awaiting EU approval. The lingering unknowns, and AB’s refusal to shine a light on them, speak volumes about the project’s likelihood of a first-pass approval. On Friday AB presented a poster on the phase III study, adding masitinib on top of gemcitabine in 353 pancreatic cancer patients, at ASCO-GI. The company’s stock had surged on the announcement of topline data from this trial last October, but no detailed analysis was offered then, and little more is forthcoming now (AB Science's dog drug data raise more questions than answers, October 31, 2012). Trial failed Although the trial had unequivocally missed its primary endpoint, what had caused the excitement was the revelation that two subgroups – patients with pain above a certain threshold and those with a particular genetic marker – had done particularly well on masitinib, boosting median overall survival versus standalone gemcitabine with barely believable p values of 0.010 and...
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