Alectinib Shines on ALK Alterations in Advanced Solid Tumors including Children

In the TACKLE phase II trial in Japan, oral alectinib achieved a central-assessed ORR of 54.2% overall, with a median PFS of 24.9 months and OS of 38.8 months; responses were especially high in ALK fusions (76.5% ORR) and inflammatory myofibroblastic tumors (100% ORR). In pediatric patients aged 15 and under (n = 11), the ORR was 63.6% (30.8 to 89.1) with a DCR of 100.0% (71.5 to 100.0). Grade ≥3 drug-related adverse events were observed in 15.4% of patients, and consistent with prior data.