Novartis is discontinuing the Phase III Enestg1 study evaluating Tasigna® (nilotinib) as first-line therapy for gastrointestinal stromal tumors (GIST). The study’s independent data monitoring committee said interim data from the trial suggest it is unlikely to demonstrate any benefits of Tasigna over Glivec® (imatinib) in terms of improving progression-free survival. The Enestg1 trial was initiated in 2009, and aimed to enroll over 700 GIST patients newly diagnosed with unresectable and/or metastatic GIST.
Tasigna is already approved in major markets including the EU, U.S,. and Japan, for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
The drug has also been approved in over 90 countries for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients who are resistant or intolerant to at least one prior therapy, including Glivec.