Ariad presented an update on a phase I-II clinical trial. The results are pretty good but confusing.
There are three cohorts of Crizotinib resistant patients. A) 90mg daily ongoing, B) 90mg daily for 7 days then 180mg daily ongoing, and C) 180mg daily ongoing. Their was similar efficacy among the cohorts.
14 evaluable patients, Objective response rate (ORR) was 79%, median Progression Free Survival (PFS) 12.9 months
26 evaluable patients, ORR was 81%, median PFS not yet been reached
25 evaluable patients, ORR was 68%, median PFS 11.1 months
In a post-hoc analysis of brain MRIs, brigatinib demonstrated intracranial Central Nervous System antitumor activity in patients.
ORR was 53% in evaluable patients with measurable lesions (greater than 10 mm) (n=15).
In evaluable patients with non-measurable lesions (all lesions less than 10 mm) (n=30), ORR (defined for these results as disappearance of all lesions) was 30%. For patients with a follow-up MRI scan (n=45), median intracranial PFS was 22.3 months.