Zidesamtinib demonstrates 93% response rate in ROS1-positive lung cancer

The global phase 1/2 ARROS-1 trial revealed remarkable results with zidesamtinib in patients suffering from advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who had not previously undergone treatment with a tyrosine kinase inhibitor (TKI). Out of 94 efficacy-evaluable TKI-naive patients, 88 out of 94 experienced an objective response, with a 94% response rate and an 86% nine-month response durability.

Remarkably, 100% of 10 patients with CNS metastases achieved intracranial response, with a 78% intracranial response durability at 12 months. In the comprehensive ARROS-1 trial, administered to 532 ROS1-positive NSCLC patients regardless of prior therapy lines (up to one), zidesamtinib showcased significant activity. The trial was conducted in a geographically diverse cohort, with 35% of participants from the Asia-Pacific region, 33% from Europe, and 32% from North America.

Treatment-related adverse events, such as peripheral edema (34%), weight gain (18%), elevated blood creatine phosphokinase (18%), dysgeusia (17%), and increased aspartate aminotransferase (15%), occurred in at least 15% of patients, leading to dose reductions in 11% of patients and treatment discontinuation in 1%. Drilon emphasized the importance of continued investigation into zidesamtinib's potential in earlier treatment stages, emphasizing the drug's safety profile and low rates of dose reduction and discontinuation.