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Updated: May 22, 2025
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Compassionate Access to Brigatinib for Patients with Non-small-cell Lung Cancer Harboring a ROS1 Rearrangement:
Jean Mourlanette1, Gaelle Rousseau-Bussac2, Siham Mallah1
1Pulmonology Department, Hôpital Larrey, CHU Toulouse, Chemin de Pouvourville, 31400, Toulouse, France.
Background:
ROS1 chromosomic rearrangement is a rare oncogenic driver, and patients with this rearrangement benefit from specific targeted treatments in the first-line setting. However, therapeutic options are limited in pretreated patients. Brigatinib is a validated drug for ALK rearrangements, and also has an in vitro activity against ROS1. In vivo efficacy is also suggested in some clinical series.
Objective:
We aimed to specifically study brigatinib in patients with pretreated advanced non-small-cell lung cancer (NSCLC).
Methods:
We retrospectively collected data from 20 centers in France. Brigatinib was delivered through a compassionate use program in France between 2018 and 2020. The primary endpoint was progression-free survival. Secondary endpoints were the objective response rate, overall survival, and tolerance.
Results:
Twenty-five patients treated with brigatinib were included in our study. All patients were pretreated, and all of them previously received crizotinib. Median progression-free survival was 3.8 months (95% confidence interval 2.8-7.1). The objective response rate was 32%, with a disease control rate of 48%. Three patients had a prolonged response of more than 18 months at the end of data collection. We did not identify factors predictive of prolonged response. There were no grade 4 or 5 toxicities.
Conclusion:
Brigatinib may represent an interesting therapeutic option for patients who have progressed after standard treatments.
Insights
Brigatinib shows promise for pretreated non-small-cell lung cancer (NSCLC) patients with ROS1 rearrangements. This study found brigatinib offers a potential treatment option with manageable toxicity after standard therapies fail.
Area of Science:
- Oncology
- Pharmacology
- Genetics
Background:
- ROS1 rearrangements are rare drivers in non-small-cell lung cancer (NSCLC), benefiting from first-line targeted therapy.
- Limited treatment options exist for pretreated NSCLC patients with ROS1 rearrangements.
- Brigatinib, effective for ALK rearrangements, demonstrates in vitro and suggested in vivo activity against ROS1.
Purpose of the Study:
- To evaluate the efficacy and safety of brigatinib in pretreated advanced NSCLC patients with ROS1 rearrangements.
Main Methods:
- Retrospective data collection from 20 French centers (2018-2020) via a compassionate use program.
- Included 25 pretreated NSCLC patients previously treated with crizotinib.
- Primary endpoint: progression-free survival; secondary endpoints: objective response rate, overall survival, and tolerance.
Main Results:
- Median progression-free survival was 3.8 months.
- Objective response rate was 32%, with a 48% disease control rate.
- No grade 4 or 5 toxicities observed; three patients achieved prolonged response (>18 months).
Conclusions:
- Brigatinib demonstrates potential as a therapeutic option for NSCLC patients progressing after standard treatments.
- Brigatinib offers a manageable safety profile in this pretreated population.
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