Just in case some missed the update today...
Here are the facts that were disclosed:
Of those that went through a prospective dosage reduction (meaning a reduction after starting at the higher dosage) experienced 7% occurrence (ATE) as compared to a 10% occurrence (those with no dosage reduction). That's a 30% reduction despite starting at the higher dosage level.
Trails with new dosage levels from inception will begin in January, which I believe will lead to a further reduction.
All this with.... retained responsiveness to the drug - continued effectiveness - at this point of which is best in class (as competitor comparator studies released at ASH show).
This in my opinion is very good news.
Here is the direct excerpt from today's results update for those that may have missed it.
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From today's PR...
Safety Update Following Prospective Dose-Reduction Recommendations (Data from October 10, 2013 to October 6, 2014)
Of the patients who underwent prospective dose reduction, 5 of 70 patients (7%) without prior events had a new arterial thrombotic event during the twelve-month interval following prospective dose reduction.
Of the patients who did not undergo prospective dose reduction, 7 of 67 patients (10%) without prior events had a new arterial thrombotic event in the same time interval.
“These data show that the majority of patients in the PACE trial retained response, even when lowering the daily dose of Iclusig,” stated Frank G. Haluska, M.D., Ph.D., senior vice president of clinical research and development and chief medical officer at ARIAD. “The safety and efficacy of Iclusig at starting doses lower than 45 mg will be studied in a randomized trial set to begin next year.”
