lung cancer

Updated Integrated Analysis of The Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion–Positive Non–Small-Cell Lung Cancer

In the April 10, 2021 edition of Journal of Clinical Oncology, investigators report on the use of entrectinib in ROS1 fusion lung cancer.  

Purpose

In the study, investigators report on the updated analysis of integrated analysis of 3 phase I or II clinical trials (ALKA-372-001, STARTRK-1, and STARTRK-2) of the ROS1 TKI , entrectinib, in ROS1 fusion–positive NSCLC patients.

Methods

Patients with locally advanced / metastatic ROS1 fusion–positive NSCLC including those with CNS metastases treated with entrectinib at least 600 mg orally daily. Objective response rate (ORR) was the co-primary end point. Progression-free survival (PFS), overall survival (OS), intracranial ORR, intracranial DoR, intracranial PFS, and safety were secondary end points.

Results

161 patients were analyzed, with a follow-up of at least 6 months. The median treatment duration was 10.7 months (IQR, 6.4-17.7). The reported ORR was 67.1% (108 patients, 95% CI, 59.3 – 74.3), and durable responses were (12-month DoR rate, 63%, median DoR 15.7 months). The 1-year PFS rate was 55% (median progression free survival 15.7 months), and the 12-month OS rate was reported as 81% (median overall survival was not estimable). 24 patients had measurable baseline CNS metastases, with a reported intracranial ORR of 79.2% (19 patients; 95% CI, 57.9 to 92.9), the median intracranial progression free survival was 12.0 months (95% CI, 6.2 to 19.3), and the median intracranial DoR was 12.9 months (12-month rate, 55%). The safety profile did not reveal any new safety signals.

Conclusion

The authors concluded “Entrectinib continued to demonstrate a high level of clinical benefit for patients with ros1 fusion–positive NSCLC, including patients with CNS metastases.”

Reference:

Updated Integrated Analysis of The Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion–Positive Non–Small-Cell Lung Cancer

https://ascopubs.org/doi/full/10.1200/JCO.20.03025

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