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Inhibition of ROS1 in NSCLC: Updated Integrated Analysis of Three Clinical Trials

By: Lauren Harrison, MS
Posted: Thursday, June 10, 2021

Treatment of patients who have ROS1 fusion–positive non–small cell lung cancer (NSCLC) with the ROS1 tyrosine kinase inhibitor entrectinib provided a significant clinical benefit. Patients with central nervous system metastases experienced an improvement in survival as well. These results were culled from three phase I or II clinical trials—ALKA-372-001, STARTRK-1, and STARTRK-2—and published in the Journal of Clinical Oncology by Fabrice Barlesi, MD, PhD, of Aix Marseille University, France, and colleagues.

Researchers enrolled 161 patients with locally advanced or metastatic ROS1 fusion–positive NSCLC. Patients received a minimum of 600 mg of oral entrectinib once a day. Patients were assessed with systematic imaging at screening, at the end of cycle 1 (4 weeks), and then every 8 weeks.

The median duration of treatment was 10.7 months, and the objective response rate was 67.1%. According to the study authors, patients had early and durable responses, with a median time to response of 0.95 months and a median duration of response of 15.7 months. The 12-month duration of response rate was 63%. The median progression-free survival was 15.7 months, and the 12-month overall survival rate was 81%.

Twenty-four patients had measurable central nervous system metastases at baseline. The intracranial objective response rate was 79.2%, and the median intracranial progression-free survival was 12.0 months. The median time to intracranial response was 0.95 months, and the 12-month intracranial duration of response was 55%.

Almost all patients (99%) experienced an adverse event on this therapy. The most frequent treatment-associated adverse events of any grade included dysgeusia (42.9%), dizziness (34.3%), constipation (31.4%), fatigue (29.5%), diarrhea (23.8%), and weight gain (20.5%). Grade 4 adverse events were noted among seven patients and included hyperuricemia, hypertriglyceridemia, limbic encephalitis, blood creatinine phosphokinase myocardial band increase, anorectal disorder, and myocarditis. There were no treatment-related deaths reported.

Disclosure: For a full list of authors’ disclosures, visit ascopubs.org.



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