Release date: 2026-05-21 15:56:15 Recommended: 11
A pivotal clinical study of brigatinib enrolled a total of 275 patients with ALK-positive NSCLC that had spread to other parts of the body. These patients ranged in age from 27 to 89 years, with a median age of 59 years. Approximately 55% were women, and 58% had never smoked. The study divided patients into two groups: 137 patients received the recommended dose regimen of brigatinib (90 mg orally once daily for the first 7 days, followed by an increase to 180 mg orally once daily); the other 138 patients received another drug, crizotinib (250 mg orally twice daily). The goal of the study was to compare the effectiveness of the two drugs in delaying disease progression.
The study results showed that patients treated with brigatinib had a significant advantage in median time to progression. Median time to progression refers to the midpoint of time from the start of treatment until disease progression or death. Data showed that the median time to progression in the brigatinib group reached 24 months, compared to only 11 months in the crizotinib group. This means that patients taking brigatinib lived twice as long without their disease worsening or spreading compared to those taking crizotinib. Furthermore, in terms of tumor shrinkage, brigatinib also performed better: three-quarters (74%) of patients treated with brigatinib experienced tumor shrinkage; in the crizotinib group, this proportion was 62%. Specifically, 101 out of 137 patients receiving brigatinib had tumor shrinkage, while only 85 out of 138 patients receiving crizotinib had tumor shrinkage.
The study also specifically evaluated the efficacy of brigatinib in patients with brain metastases. Researchers performed an independent analysis on 41 patients with brain metastases. The results were encouraging: among the 18 patients with brain metastases treated with brigatinib, 14 (78%) experienced shrinkage or disappearance of brain tumors; among the 23 patients with brain metastases treated with crizotinib, only 6 (26%) achieved a similar response. This means that for every 4 patients whose cancer had spread to the brain, 3 experienced brain tumor shrinkage after treatment with brigatinib. Moreover, among those who responded to brigatinib in the brain, more than half (9 out of 14) had a response lasting 2 years or longer. These data fully demonstrate the potent ability of brigatinib to control brain metastases.