Hypolobated small megakaryocyte

ARIAD Pharmaceuticals is terminating the Phase III EPIC (‘Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia’) trial of its oral drug candidate Iclusig (ponatinib) in patients with newly diagnosed chronic myeloid leukaemia (CML).

The US Food and Drug Administration (FDA) and ARIAD have agreed to stop the trial because arterial thrombotic events were observed in patients treated with the drug.

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Decision to terminate the trial was made in view of patient safety and is based on a recent assessment of data in the clinical trial.

ARIAD president of research and development and chief scientific officer Timothy Clackson said stopping the EPIC trial at this time is based on the current evaluation of the safety data in the trial since it was placed on partial clinical hold last week.

"We believe that this is in the best interests of patient safety and the overall development of Iclusig," Clackson said.

A total of 307 patients were enrolled in the randomised, two-arm, multicentre EPIC trial and they are now being removed from treatment and will be shifted to the care of their physician.

Conducted at some 150 investigational sites in more than 20 countries, the trial was intended to compare the efficacy of ponatinib with that of imatinib in adult patients with newly diagnosed CML in the chronic phase.

The company said patients in the trial had to be at least 18-years-old and diagnosed with CML within six months prior to enrolment.

Around 500 patients were to be given the standard dose of ponatinib 45mg given orally once daily or imatinib 400mg given orally once daily and increasing the imatinib dose to 600mg or 800mg per day was allowed.

"We believe that this is in the best interests of patient safety and the overall development of Iclusig."

The primary endpoint of the EPIC trial was major molecular response at one year of treatment.

The drug is currently available in the US and EU markets for patients with resistant or intolerant CML and Philadelphia-chromosome positive acute lymphoblastic leukaemia.

The company said it would continue to work with health authorities to make necessary changes to the Iclusig product labelling to reflect the recently announced safety findings from the PACE trial that was the basis of its marketing approvals.

Iclusig is an orally administered, multi-targeted kinase inhibitor that has broad potential applications in cancer; it is indicated for the treatment of resistant or intolerant chronic myeloid leukaemia and Philadelphia chromosome-positive acute lymphoblastic leukaemia.

It was designed using ARIAD’s computational and structure-based drug design platform specifically to inhibit the activity of BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukaemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL).

Image: A small, hypolobated megakaryocyte in a bone marrow aspirate, typical of chronic myelogenous leukemia. Photo: courtesy of Difu Wu.