ARIAD Pharmaceuticals, Inc. (ARIA) recently completed 50% enrollment in the randomized phase III EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) study being conducted on Iclusig (ponatinib) in newly diagnosed chronic myeloid leukemia (:CML) patients. EPIC will evaluate treatment-naive CML patients.
The randomized (1:1), two-arm, multicenter EPIC study will compare the efficacy of Iclusig with that of Novartis’ (NVS) Gleevec (imatinib) in newly diagnosed in adult CML patients. Full enrolment of 500 patients is likely to complete by the end of 2013.
The primary endpoint of the study is major molecular response (:MMR) of patients at 1 year of treatment. Main secondary endpoints include MMR at five years and molecular response (MR) at three months of treatment.
Interim analysis of the study is due in the third quarter of 2014.
Iclusig, a tyrosine kinase inhibitor (:TKI), launched in the U.S. in Jan 2013, is currently marketed by Ariad for treating adults suffering from CML, and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), who are resistant or intolerant to TKI therapy. Ariad recorded Iclusig sales of $13.9 million in the second quarter of 2013.
In Jul 2013, Ariad gained EU approval for Iclusig in two indications. The first indication is the treatment of chronic phase, accelerated phase or blast phase CML in adults who do not respond to or cannot tolerate Sprycel or Tasigna. It is also approved for patients in whom Gleevec is not appropriate as a subsequent treatment. The second indication covers the treatment of Ph+ ALL in adults unresponsive to Sprycel. It also includes patients for whom Gleevec is not clinically appropriate. Iclusig is also approved for patients who have the T315I mutation.
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