Abstract 9009 is a phase 1 dose escalation trial (dose levels ranged from 10-200 mg and the Recomended phas 2 dose was 100 mg once daily). There were 54 patients as of November 30, 2015. 41 are ALK positive and 12 are ROS1 positive. 29 patients remain on treatment.
The analysis of results was broken down into 3 sub groups (for simplicity sake I combine confirmed and unconfirmed results).
Group A had intracranial and extracranial mets. And had an Overall Response rate of 50% (6% complete responses and 44% partial response rate).
Group B had intracranial mets (target and non target mets). And had an Overall Response rate of 44% (28% complete responses and 17% partial response rate).
Group C had intracranial mets (target mets only). And had an Overall Response rate of 60% (30% complete responses and 30% partial response rate).
A phase 2 study is expected to enroll 240 patients across 6 cohorts.