Top 5 Clinical Setbacks of 2014: Exelixis’s Cometriq.
The third clinical study crash identified by Datamonitor Healthcare and SCRIP was in oncology. The late-stage trial crash and burn with the biggest ramifications for the company was Exelixis. Cometriq (cabozantinib) failed to demonstrate overall survival in the Phase III COMET-1 trial in in men with metastatic castration-resistant prostate cancer (mCRPC).
Exelixis announced a 70% reduction in its workforce following the news.
Cometriq is already approved in Europe and the US in the much smaller indication of progressive, metastatic medullary thyroid cancer (MTC). However, its real commercial potential was in the mCRPC indication.
Datamonitor analyst Joseph Hedden said that as Cometriq missed its endpoints in one Phase III trial and subsequently the whole development program was put on hold, “it very much looks like development will be terminated.” As Exelixis’ only drug, the Phase III failure was a major setback
But wasn’t a complete shock though; Exelixis’ shares had already taken a beating following an interim review of COMET-1 in March. There was no specific safety or efficacy concern, but investors sent the company’s stock down 39% to close at $3.90 per share on 26 March in the absence of early data that showed a competitive advantage over available therapies.
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