Alectinib shows activity in phase II trial of ALK-altered solid tumors

Prospective evidence for alectinib beyond lung cancer remains limited. The multicenter, open-label phase II TACKLE study enrolled 26 patients aged 8 months to 78 years with 11 types of advanced ALK-altered solid tumors. Patients received capsules or suspension. The primary endpoint was centrally confirmed objective response rate (ORR) by RECIST v1.1 in patients receiving intact capsules, using a Bayesian design with an expected ORR of 40% and a threshold of 10%.

At a median follow-up of 15.0 months, ORR was 43.8% among 16 patients with measurable disease in the intact-capsule cohort, meeting the primary endpoint. Among 24 evaluable patients overall, ORR was 54.2% and disease control rate was 75.0%. Median progression-free and overall survival were 24.9 and 38.8 months, respectively. Among 17 evaluable patients with ALK fusions or rearrangements, ORR was 76.5%. All patients with inflammatory myofibroblastic tumors had tumor shrinkage, with a reported ORR of 87.5%.

Patients aged 15 years or younger (n=11) had an ORR of 63.6% and disease control rate of 100%. Grade 3 or higher treatment-related adverse events occurred in four patients (15.4%), with no treatment-related deaths. These findings support further tumor-agnostic investigation, but the small, heterogeneous population and lack of a reported comparator limit conclusions about comparative benefit and individual tumor types. Only the abstract was available for review.