Ariad Pharm announces changes in the clinical development program of iclusig; patient enrollment in all clinical studies of iclusig is being paused
Co announced results of its review of updated clinical data from the pivotal PACE trial of Iclusig and actions that it is taking following consultations with the FDA. With a median follow up of 24 months, serious arterial thrombosis occurred in 11.8% of Iclusig-treated patients: cardiovascular events 6.2%, cerebrovascular events 4.0% and peripheral vascular events 3.6%.
This compares to 8.0% after 11 months of follow up reflected in the current U.S. prescribing information. At 24 months, serious venous occlusion occurred in 2.9% of Iclusig-treated patients, compared to 2.2% in the current U.S. prescribing information.
The incidence rate of the arterial thrombotic events when normalized to duration of treatment exposure has not increased (10.0 events/100 patient-years in the original analysis and 9.6 events/100 patient-years in the current analysis). Non-serious and serious arterial and venous adverse events combined occurred in approximately 20% of Iclusig-treated patients.
The Company is implementing the following actions in its Iclusig clinical development program: Patient enrollment in all clinical studies of Iclusig is being paused, and subject to agreement with the FDA, will be resumed with anticipated changes in dose and other modifications. In concert with this action, the FDA placed a partial clinical hold on all new patient enrollment in clinical trials of Iclusig. Patients who are currently receiving Iclusig in clinical trials will continue on therapy. Reductions in Iclusig dose from 45 mg daily will be implemented on a trial-by-trial basis for patients whose Iclusig treatment is ongoing.
The PACE trial data demonstrate continued efficacy after dose reduction. Of 270 chronic-phase patients in the pivotal study, 190 patients dose reduced to either 30 mg or 15 mg. Of 110 (58%) patients who initially achieved a major cytogenetic response (MCyR), over 90% of these patients maintained this response after a median follow up of 19 months, despite dose reduction. Of 35 patients who achieved a MCyR and subsequently were reduced to 15 mg, all but 2 patients maintained the response.
At this time, the U.S. prescribing information for Iclusig is unchanged. Iclusig continues to be available in the U.S. to patients with resistant or intolerant chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia in the commercial setting at the approved, once-daily dose of 45 mg.