Ariad announces start of Phase 3 trial

Ariad today announced the initiation of a first line phase 3 trial comparing Brigatinib with Crizotinib. Patients must be ALK inhibitor naive. They are planning to enroll around 270 patients. They expect to complete enrollment in 2018.

Of interest, the Brigatinib arm of the trial will be 90 mg once daily for 7 days followed by a escalation to 180 mg once daily. This suggests that the risk reward analysis from the phase 2 trial between 90 mg daily permanently and 90 mg for 7 days followed by 180 mg daily permanently, must have favored the higher dose (the side effects must have only increased a bit and the benefit in terms of tumor shrinkage or duration or both must have been significant as well). As far as I know this result has not been previously announced.

Separately, Ariad has posted a phase 2 trial on Clinicaltrials.gov but not posted a related press release yet. This is a trial of only about 40 patients and is looking at Brigatinib in the third line setting after patients have relapsed on Ceritinib or Alectinib.

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