Ariad has paused patient enrolment for clinical studies involving its cancer drug Iclusig after some patients were found to have experience blood clots, cardiovascular events and other side effects.
Iclusig (ponatinib) received early approval in the US last year for the treatment of advanced chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), under the proviso that Ariad conducted additional studies to confirm the drug’s clinical benefit and safety.
A review of data from the PACE trial further investigating the use of Iclusig in patients with CML and Ph+ ALL revealed patient safety issues that forced Ariad to take action following consultation with the US Food and Drug Administration (FDA).
This data demonstrates that after two years of follow-up treatment, serious arterial thrombosis – a blood clot in the artery – occurred in 11.8 per cent of patients treated with Iclusig. This compared to 8.0 per cent of patients after 11 months of follow-up treatment.
Other adverse events reported in people treated with Iclusig included cardiovascular events (6.2 per cent), cerebrovascular events (4.0 per cent) and peripheral vascular (3.6 per cent).
The new data has led Ariad to implement a halt on patient enrolment for clinical studies of Iclusig while the company works out changes in dose and other trial modifications needed to improve safety.
Cancer patients who are currently receiving Iclusig in clinical trials will continue to be treated with the drug, although the current 45mg daily dose will be reduced on a trial-by-trial basis, according to the company.
Affected trials include the phase III EPIC trial to assess Iclusig in patients with newly diagnosed and treatment-naïve CML. In this trial, patients will be moved to a 30mg daily dose unless they have achieved a major molecular response, in which case the dose will be reduced to 15mg daily.
Ariad also intends to update the eligibility criteria for Iclusig trials to exclude patients who have experienced prior arterial thrombosis resulting in heart attack or stroke.
The company said that no US prescribing information changes for Iclusig have been made yet, although discussions are being held with the FDA to update the product label to reflect the new information.
Ariad has also informed the European Medicines Agency (EMA) of the new data, which comes several months after Iclsuig was approved by the European Commission.