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Gregory J. Riely, MD, PhD


Updated Data on Entrectinib in NTRK Fusion–Positive NSCLC

By: Julia Fiederlein Cipriano, MS
Posted: Wednesday, March 13, 2024

According to Thomas John, MD, of Peter MacCallum Cancer Centre, Melbourne, Australia, and colleagues, an integrated analysis of three phase I/II studies (ALKA-372–001, STARTRK-1, and STARTRK-2) revealed deep and durable overall and intracranial responses in patients with NTRK fusion–positive solid tumors who underwent first-line treatment with the central nervous system (CNS)-active tyrosine kinase inhibitor (TKI) entrectinib. The results of an updated analysis of the non–small cell lung cancer (NSCLC) subgroup, which were published in the journal Lung Cancer, appeared to be consistent with those for the overall study population.

The efficacy-evaluable population comprised 51 patients (median age, 60 years) with locally advanced or metastatic disease who underwent tumor response assessment by blinded independent central review at 4 weeks and every 8 weeks thereafter. With a median duration of survival follow-up of 26.3 months, the objective response rate was 62.7%; a total of 6 complete and 26 partial responses were observed. The median durations of response, progression-free survival, and overall survival were 27.3, 28.0, and 41.5 months, respectively. In the 14 patients who had blinded independent central review–assessed baseline CNS metastases, the intracranial objective response rate was 64.3% (n = 9; complete response: n = 7), and the intracranial duration of response was 55.7 months.

According to the investigators, in the safety-evaluable population (n = 55), the majority of treatment-related adverse events were of grade 1 or 2. No treatment-related deaths were documented.

“The data described in this analysis support the use of entrectinib as a first-line treatment for patients with NTRK gene fusion–positive NSCLC, including those with baseline CNS disease,” the investigators concluded. “Further investigation is needed to increase our understanding of the prognosis of patients in this rare population and their long-term outcomes with entrectinib.”

Disclosure: For full disclosures of the study authors, visit

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