Novartis 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[1]. 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.
About ENESTg1
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.
About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, consumer health products, preventive vaccines and diagnostic tools. Novartis is the only company with leading positions in these areas. In 2010, the Group's continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 119,000 full-time-equivalent associates and operate in more than 140 countries around the world.
1. Novartis. Phase III, Open-label Study of Nilotinib Versus Imatinib in GIST Patients (ENESTg1). http://clinicaltrials.gov/ct2/show/NCT00785785?term=Nilotinib+Versus+Imatinib+in +Adult+Patients+With+Unresectable+or+Metastatic+Gastrointestinal+Stromal+Tumors &rank=1 Accessed March 2011.
* Known as Gleevec® (imatinib mesylate) tablets in the US, Canada and Israel.