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The primary report of ALTA: after crizotinib, brigatinib shrank tumours in about half of patients, more so at the 180 mg dose after a week at 90 mg, and held the disease for around a year.
Randomised phase 2 trial of two brigatinib regimens in 222 patients with ALK-positive non-small-cell lung cancer that had progressed on crizotinib, stratified by brain metastases and best response to crizotinib: 90 mg once daily (arm A) or 180 mg once daily after a 7-day 90 mg lead-in (arm B). The primary endpoint was investigator-assessed confirmed objective response rate.
At 8.0 months median follow-up the confirmed response rate was 45 percent in arm A and 54 percent in arm B; median progression-free survival was 9.2 and 12.9 months. Intracranial response by independent review in patients with measurable brain metastases was 42 percent (11 of 26) and 67 percent (12 of 18). Early-onset pulmonary adverse events occurred in 14 of 219 treated patients, none after escalation to 180 mg in arm B.
This is the trial behind brigatinib's first approval, after crizotinib, and it set the 180 mg dose with a 90 mg lead-in that the label uses. For a patient it shows a drug with strong activity in the brain and an unusual early lung side effect that the lead-in week was designed to soften.
Shares ALTA, D. Ross Camidge, Brigatinib, Takeda.
Shares ALK-positive non-small-cell lung cancer, ALK, Non-small-cell lung cancer.
Shares Dong-Wan Kim, D. Ross Camidge, ALK-positive non-small-cell lung cancer, ALK.
Shares ALK-positive non-small-cell lung cancer, ALK, Non-small-cell lung cancer.
Shares ALK-positive non-small-cell lung cancer, ALK, Non-small-cell lung cancer.
Shares D. Ross Camidge, ALK-positive non-small-cell lung cancer, ALK, Non-small-cell lung cancer.
Shares Takeda, Non-small-cell lung cancer.
Shares ALK-positive non-small-cell lung cancer, ALK, Non-small-cell lung cancer.