Compassionate Access to Brigatinib for Patients with Non-small-cell Lung Cancer Harboring a ROS1 Rearrangement:...

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.