Swiss drugmaker Novartis has ditched a late-stage study assessing Tasigna's potential in a rare type of stomach cancer, but would have been somewhat cheered by a new analysis supporting the use of Gilenya in multiple sclerosis.
Novartis said it has dropped a Phase III trial of Tasigna (nilotinib) after data indicated that the drug was unlikely to demonstrate superiority in progression-free survival over the current standard of care Glivec (imatinib) in patients with unresectable and/or metastatic gastrointestinal stromal tumors (GIST).
The decision to pull the plug on the trial, which is called ENESTg1 and was initiated back in 2009, was based on the recommendation of an independent data monitoring committee, the firm noted.
The news will have come as a bit of a blow to Novartis as analysts were predicting that, if approved, Tasigna could generate sales of around $500 million in the GIST indication, according to media reports.
Tasigna, which the company has long touted as the successor to its blockbuster Glivec, was approved on both sides of the Atlantic in 2007 for chronic myeloid leukaemia and raked in sales of $399 million in 2010.
Gilenya shines in MS trial
In more positive news for the company, a fresh analysis of data on its multiple sclerosis drug Gilenya (fingolimod) showed that it cut the risk of disability progression in patients with relapsing-remitting firms of the condition, regardless of previous treatment.
Data from the two-year FREEDOMS trial has already demonstrated that Gilenya reduced relapses of the disease by 54% compared to a placebo.
Now, a new analysis of data presented at the American Academy of Neurology showed that 0.5 mg Gilenya-treated patients who were new to therapy had a 37% lower risk of three-month confirmed disability progression than those taking a placebo, while previously treated patients had a 30% reduction in risk.
Gilenya, which Novartis licensed from Mitsubishi Tanabe Pharma, is the first pill in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators, and is approved for use in more than 35 countries around the world.