Biomarker NTRK Coverage from Every Angle

Entrectinib in NTRK Fusion– and ROS1 Fusion–Positive Solid Tumors: Patient-Reported Outcomes

By: Kayci Reyer
Posted: Sunday, August 1, 2021

According to patient-reported outcomes from the phase II basket study STARTRK-2 presented in ESMO Open Cancer Horizons, entrectinib may have a positive benefit-risk profile and a minor overall treatment burden in some patients with non–small cell lung cancer. Luis Paz-Ares, MD, PhD, of Hospital Universitario 12 de Octubre, Madrid, and colleagues sought to determine the effect of entrectinib on outcomes among patients with locally advanced or metastatic NRTK1/2/3 and ROS1 fusion–positive solid tumors.

Patients were assigned to either efficacy analysis (EA-PRO; n = 216) or safety analysis (SA-PRO; n = 268) cohorts. Patients in the SA-PRO cohort received at least one dose of entrectinib. They also answered a first-day prespecified secondary endpoint (PRO) questionnaire and at least one question during treatment. The EA-PRO cohort were members of the SA-PRO group who had measurable disease. Throughout treatment, moderate-to-high baseline global health status scores were maintained, whereas baseline role and physical functioning scores trended toward clinical improvement in the EA-PRO cohort. Baseline symptom burden was low to moderate and was either maintained or trended toward clinically significant improvement for both cohorts.

All patients in the SA-PRO cohort experienced at least one adverse event. The most frequently reported adverse events were constipation and diarrhea. Common symptoms of cancer treatment, such as nausea and fatigue, were either maintained or improved during treatment with entrectinib. According to the study authors, a clinically meaningful, rapid, and sustained improvement in cough was noted for patients with ROS1 fusion–positive non–small cell lung cancer.

Disclosure: For full disclosures of the study authors, visit

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