Among patients with ALK-rearranged non-small cell lung cancer (NSCLC) who have been treated with crizotinib or are crizotinib-naive, brigatinib demonstrates clinical activity and an acceptable safety profile, according to a study published in The Lancet Oncology.1
Researchers conducted a phase 1/2 trial of 137 patients with NSCLC, 79 of whom had advanced malignancies such as ALK-rearranged NSCLC.
All 4 patients with ALK inhibitor-naive ALK-rearranged NSCLC had an objective response, as did 31 out of 42 patients with crizotinib-treated ALK-rearranged NSCLC, and 3 out of 18 patients who had other types of cancer with abnormalities in brigatinib targets.
Three out of 6 patients who had crizotinib-naive or crizotinib-treated ALK-rearranged NSCLC and active central nervous system metastases also had an objective response, and 3 patients within the same group had intracranial response.
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Among 8 patients with crizotinib-naive ALK-rearranged NSCLC, all had a confirmed objective response.
Across all dosage levels, increased lipase concentration, dyspnea, and hypertension were the most common grade 3 to 4 treatment-emergent adverse events. Serious adverse events found in at least 5% of patients were dyspnea, pneumonia, and hypoxia.
- Gettinger SN, Bazhenova LA, Langer CJ, et al. Activity and safety of brigatinib in ALK-rearranged non-small-cell lung cancer and other malignancies: a single-arm, open-label, phase 1/2 trial. Lancet Oncol. 2016 Nov 7. doi: 10.1016/S1470-2045(16)30392-8 [Epub ahead of print]