Zidesamtinib Shows Promising Results in Treating ROS1-Positive NSCLC

Zidesamtinib, a new drug for treating advanced ROS1-positive non-small cell lung cancer (NSCLC), has shown promising results in a recent clinical trial. The drug demonstrated a 94% objective response rate among TKI-naive patients, according to data presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC).

The global Phase I/II ARROS-1 trial involved 94 TKI-naive patients with advanced or metastatic ROS1-positive NSCLC. Among these, 88 patients (94%) achieved an objective response, with a nine-month duration-of-response rate of 94% and a 12-month rate of 86%. The drug also showed significant intracranial activity, with a 100% intracranial objective response rate and a 70% intracranial complete response rate among 10 evaluable patients with central nervous system metastases. The nine-month intracranial duration-of-response rate was 100%, and the 12-month rate was 78%.

The ARROS-1 trial included a single-arm cohort of patients with locally advanced or metastatic ROS1-positive NSCLC who had not previously received a tyrosine kinase inhibitor (TKI). Patients received zidesamtinib 100 mg once daily, with up to one prior line of chemotherapy or immunotherapy allowed. The study population was geographically diverse, with 35% of patients enrolled in the Asia-Pacific region, 33% in Europe, and 32% in North America.

Alexander Drilon, M.D., from Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, commented on the findings. "Zidesamtinib demonstrated clinically meaningful activity in TKI-naive patients with ROS1-positive NSCLC, with a safety profile consistent with previous reports and low rates of dose reduction and discontinuation. The findings support continued investigation of zidesamtinib in earlier lines of therapy."

The most common treatment-related adverse events, occurring in at least 15% of patients, included peripheral edema (34%), increased weight (18%), increased blood creatine phosphokinase (18%), dysgeusia (17%), and increased aspartate aminotransferase (15%). Treatment-related adverse events led to dose reductions in 11% of patients and treatment discontinuation in 1% of patients.

The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. The IASLC's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies.

The WCLC, the world's largest meeting dedicated to lung cancer and other thoracic malignancies, attracts nearly 7,000 researchers, physicians, and specialists from more than 100 countries. The conference aims to increase awareness, collaboration, and understanding of lung cancer and help participants implement the latest developments across the globe.