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Early-Phase Studies of Entrectinib for the Treatment of NTRK Fusion–Positive Solid Tumors

By: Dana A. Elya, MS, RD, CDN
Posted: Monday, January 13, 2020

A pooled analysis of three early-phase clinical trials (STARTRK-1, STARTRK-2, and ALKA) indicates that entrectinib may be a safe and active treatment option for patients with NTRK fusion–positive tumors. Robert C. Doebele, MD, PhD, of the University of Colorado Cancer Center in Aurora, and colleagues concluded that the data highlight the need to routinely test for NTRK fusions to broaden the therapeutic options available for these patients. The research on this inhibitor of tropomyosin receptor kinases was published in The Lancet Oncology.

“The gene NTRK is on a growing list of known genetic drivers of non–small cell lung cancer,” shared Dr. Doebele in a University of Colorado Cancer Center press release. “Only by testing for genes like NTRK can we match these genetic drivers of cancer with drugs like entrectinib.”

Researchers used a database of these three ongoing phase I or II clinical trials. A total of 54 patients with metastatic or locally advanced NTRK fusion–positive solid tumors, comprising 10 different tumor types and 19 different histologies, were part of the study. All patients received 600 mg of entrectinib orally daily. 

The average follow-up was 12.9 months. All patients had an objective response, of which 4 (7%) were complete responses and 27 (50%) were partial responses. The average duration of response was 10 months.

The most common side effects were increased weight (8%) and neutropenia (4%). Serious adverse events occurred in 11% of patients and included nervous system disorders (3%) and cardiac disorders (2%). There were no treatment-related deaths.

“Entrectinib induced durable and clinically meaningful responses in patients with NTRK fusion–positive solid tumors and was well tolerated with a manageable safety profile,” concluded the researchers.

Disclosure: The authors’ disclosures can be found at thelancet.com.



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