Novartis announced Monday that it is halting a late-stage trial investigating Tasigna (nilotinib) as a first-line treatment in patients with gastrointestinal stromal tumours (GIST) as the drug is "unlikely to demonstrate superiority" compared to standard therapy of Glivec (imatinib).
The company noted that the decision to stop the ENESTg1 study was based on the recommendation of an independent data monitoring committee. The trial, which started in 2009, was expected to enrol more than 700 patients with newly diagnosed, unresectable and/or metastatic GIST and had a main goal of comparing progression-free survival between Tasigna and Glivec.
Analysts commented that the termination of the trial was a disappointment, noting that Tasigna could have achieved annual sales of around $500 million in this indication. The drug, which Novartis views as a replacement to Glivec, is already approved to treat patients with various forms of chronic myeloid leukaemia.
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