Patients with non-small cell lung cancer (NSCLC) with ROS1 gene fusions saw clinical activity after treatment with entrectinib, according to results of an integrated analysis of 3 ongoing phase 1/2 trials.1

The analysis looked at results from the ALKA-372-001, STARTRK-1, and STARTRK-2 trials. Included patients had locally advanced or metastatic disease and were treated with entrectinib at a dose of at least 600 mg orally once per day with 12 months’ follow-up.

At data cutoff, 41 of 53 patients had an objective response to treatment. At a median follow-up of 15.5 months, the median duration of response was longer than 2 years (24.6 months). Median progression-free survival was 19.0 months.

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Twenty patients had baseline central nervous system metastases, and 11 of these progressed. The median progression-free survival among these patients was 13.6 months. Among those (30 patients) without baseline CNS metastases, the median progression-free survival was 26.3 months.

About 60% of treatment-related adverse events were grade 1 or 2 in the safety-evaluable population (134 patients). Grade 3/4 treatment-related adverse events occurred in 46 (34%) of patients. The most common grade 3/4 event was weight increase and neutropenia.

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Although no treatment-related deaths occurred, 11% of patients had serious treatment-related adverse events.

In an editorial that accompanied the study, Ulrik Lassen, of Rigshospitalet, Copenhagen, Denmark, pointed out that the results of this pooled analysis are based on single-arm studies with a small number of patients.2

“The collection of additional data after the approval [of] entrectinib will be important to gain real-world experience and improve strategies for identifying patients with rare gene fusions who might benefit from such targeted therapies,” he wrote.

Disclosure: The authors reported financial relationships with various pharmaceutical and medical device companies. For a full list of disclosures, please refer to the original study.

Editor’s note: The headline of this article was corrected to better align with the prescribing information for entrectinib.


  1. Drilon A, Siena S, Dziadziusko R, et al. Entrectinib in ROS1 fusion-positive non-small cell lung cancer: integrated analysis of three phase 1-2 trials. Lancet Oncol. doi: 10.1016/S1470-2045(19)30690-4
  2. Lassen U. Entrectinib for ROS1 fusion-positive NSCLC and NTRK fusion-positive solid tumours. Lancet Oncol. doi: 10.1016/S1570-2045919030789-2