Biomarker NTRK Coverage from Every Angle

ESMO 2021: Updated Analysis of Entrectinib in Advanced NTRK Fusion–Positive Solid Tumors

By: Vanessa A. Carter, BS
Posted: Wednesday, September 22, 2021

Lyudmila Bazhenova, MD, of Moores Cancer Center, University of California, San Diego, and colleagues conducted a study to evaluate the safety and efficacy of entrectinib in patients with metastatic or locally advanced NTRK fusion–positive solid tumors. Their updated results in a larger cohort of patients, presented during the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract 533P), concluded that the TRK inhibitor continues to be well tolerated, with clinically meaningful efficacy.

A total of 121 patients with metastatic or locally advanced NTRK fusion–positive solid tumors were eligible for analysis. The most common tumor types represented in the study were sarcoma (n = 26), salivary mammary analog secretory carcinoma (n = 24), non–small cell lung cancer (NSCLC; n = 22), thyroid cancer (n = 13), and colorectal cancer (n = 10). Tumors were assessed by blinded independent central review.

The median patient age was 57 years, and the majority (90.9%) of patients had an Eastern Cooperative Oncology Group performance score of 0 or 1; 40.5% of participants received two or more prior therapy lines. The median survival follow-up was 25.8 months, and the median duration of treatment was 11.0 months. Responses were observed across all tumor types, including 19 complete responses, yielding an objective response rate of 61.2%.

Patients with salivary cancer, such as mammary analog secretory carcinoma, demonstrated the highest objective response rate at 83.3%, followed by those with pancreatic (75%), breast (71.4%), NSCLC (63.6%), sarcoma (57.7%), and thyroid (53.8%) cancers. Notably, patients with neuroendocrine (40%) and colorectal (20%) cancers had the lowest objective response rates. The median duration of response was 20.0 months, with a median progression-free survival and overall survival of 13.8 and 33.8 months, respectively.

The safety-evaluable population included 193 patients. The most common grade 1 or 2 treatment-related adverse events were dysgeusia (35.2%), diarrhea (31.1%), fatigue (27.5%), and weight increase (27.5%).

Disclosure: For full disclosures of the study authors, visit

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