Multicenter phase 1-2 trial of ficonalkib for advanced ALK-positive NSCLC resistant to second-generation ALK TKIs

There are limited treatment options for patients with advanced ALK-positive non-small cell lung cancer that is resistant to second-generation ALK tyrosine kinase inhibitor. Ficonalkib (SY-3505) is a third-generation ALK TKI. A multicenter phase 1-2 trial in China evaluated ficonalkib for advanced ALK-positive NSCLC resistant to second-generation ALK-TKIs. After phase 1, ficonalkib 600 mg once daily was chosen as recommended phase 2 dose. In phase 2, treatment-related adverse events were seen in 90,9% of patients, and grade 3 or higher TRAEs in 14.8%. The objective response rate was 47.5% (95% CI 36.2-59.0) and the intracranial ORR among patients with baseline measurable brain metastases was 37.5% (21.1-56.3). The authors conclude that ficonalkib was well tolerated, with a favorable safety profile and promising efficacy among patients with advanced ALK-positive NSCLC resistant to prior second-generation ALK TKI.