Its not new, these results were presented at EHA 2016 (Abstract E1110) in June. From the poster 'Summary' section: "Risk factors were present in both groups, and there was no significant difference in incidence of AESIs (adverse events of special interest) between groups; however, a trend toward more AOEs in patients with low dose ponatinib (P=0.076) was noted, perhaps due to patient selection or post-event dose reduction."
These patients were retrospectively stratified between <30mg/day and >30mg/day, so "low-dose" here means average dose for duration of study was <30mg/day, and gaps in therapy were included as 0mg/day. So we don't know if any of these patients ever saw 15mg/day as required by the 'induce, reduce, maintain" strategy currently under investigation in OPTIC and OPTIC-2L. Keep in mind one arm of OPTIC-2L is using 15mg as starting dose, with reduction to 10mg. And with only 15 low-dose patients (35 total in study) any predictive conclusion drawn from this study is premature and must be qualified by the types of statements made by the authors made above. To answer your question, no I don't think it's possible that lower doses yield higher event rates, but at this point its not a meaningful debate to have until ASH 2017 (December), first readout of OPTIC.
|