Novartis drops Ph III Tasigna trial for GIST; in-licenses Sativex; and reports new Gilenya data

In what has been a couple of busy and mixed news days for Swiss drug major Novartis (NOVN: VX), this morning the company said it was discontinuing a Phase III trial of Tasigna (nilotinib). In addition, it was announced that it had in-licensed certain rights to the cannabis-based drug Sativex and also new clinical data supporting its oral diabetes drug Gilenya (fingolimod), as well as an update on Afinitor (everolimus).

Based on the recommendation of an independent data monitoring committee, Novartis has stopped a Phase III study of Tasigna for investigational use in the first-line treatment of gastrointestinal stromal tumors (GIST), noting that interim results showed the drug is unlikely to demonstrate superiority compared to Glivec (imatinib), the current standard of care in this setting. Tasigna is already marketed and, for 2010, generated sales of $399 million, a year-on-year increase of 88%.

The trial is a randomized, open-label, multicenter study evaluating the efficacy and safety of nilotinib versus imatinib in adult patients with unresectable and/or metastatic GIST. The side effect profile seen in this trial was consistent with previous studies of Tasigna. Novartis said it is committed to further advancing treatment options for patients with GIST and continues to explore studies for these patients.