Ariad ditches CML trial
pharmafile | October 21, 2013 | News story | Research and Development, Sales and Marketing | Ariad, CML, iclusig
Ariad Pharmaceuticals has ditched its late-stage trial of Iclusig in patients with newly-diagnosed chronic myeloid leukemia (CML) after blood clots were reported.
It is a huge blow for the US manufacturer, which ‘mutually agreed’ with the FDA that the Phase III EPIC trial should be terminated because patients treated with Iclusig (ponatinib) suffered arterial thrombotic events.
The study was suspended before being scrapped completely and the 300 or so patients from EPIC are being removed from treatment.
“Our decision to stop the EPIC trial at this time is based on our current evaluation of the safety data in the trial since it was placed on partial clinical hold last week,” said Ariad’s chief scientific officer Timothy Clackson.
“We believe that this is in the best interests of patient safety and the overall development of Iclusig,” he added.
Iclusig is available in the US and Europe for patients with resistant or intolerant CML and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Analyst EP Vantage warned: “The situation has moved from bad to worse for Ariad Pharmaceuticals. This news not only dashes any lingering hope that the product will become a significant treatment in this disease. It also raises the prospect of an even worse outcome for Ariad – the withdrawal of the product from the market.”
Ariad said it was working with authorities to change Iclusig’s labelling “to reflect the recently announced safety findings from the pivotal PACE trial that was the basis of its marketing approvals”.
The manufacturer had been bullish about the drug’s prospects at the beginning of the year, confident that its mode of action is different from existing brands in the field – tyrosine kinase inhibitors (TKIs) such as Novartis’ Glivec (imatinib), Novartis’ Tasigna (nilotinib) and Bristol-Myers Squibb’s Sprycel (dasatinib).
It works by bypassing T315I, the so-called ‘gatekeeper’ mutation in CML which has been associated with resistance to other approved TKIs. Its primary target is BCR-ABL, an abnormal tyrosine kinase expressed in CML and Ph+ ALL.
EPIC was a randomised, two-arm, multi-centre trial comparing Iclusig’s efficacy with that of Novartis’ Glivec (imatinib) in adults with newly-diagnosed chronic CML.
Patients were to be randomised 1:1 to the standard dose of Iclusig (45 mg) or Glivec (400 mg), both given orally once-daily.
Increasing the Glivec dose to 600 mg or 800 mg per day was permitted, with the primary endpoint being major molecular response at 12 months of treatment.
Adam Hill
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