Independent data monitoring committee recommends stopping ENESTg1 trial as interim efficacy results show Tasigna is unlikely to show superiority
Novartis remains committed to advancing treatment options for patients with GIST
Basel, April 11, 2011 - Novartis announced today it is discontinuing a Phase III trial of Tasigna (nilotinib) for investigational use in the first-line treatment of gastrointestinal stromal tumors (GIST) based on the recommendation of an independent data monitoring committee. Interim results showed Tasigna is unlikely to demonstrate superiority compared to Glivec (imatinib)*, the current standard of care in this setting.
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 is committed to further advancing treatment options for patients with GIST and continues to explore studies for these patients.
ENESTg1 (Evaluating Nilotinib Efficacy and Safety in Clinical Trials Versus Imatinib in Adult Patients With Unresectable and/or Metastatic GIST) began in 2009 in centers across the world with the goal of recruiting more than 700 GIST patients. These patients were newly diagnosed with unresectable and/or metastatic GIST and were not permitted to receive any prior cancer therapies other than adjuvant Glivec.
The trial’s primary endpoint was a comparison of progression-free survival between Tasigna and Glivec when used as initial therapy in these patients.