Deulorlatinib (TGRX-326) in ALK Gene Fusion Positive NSCLC After Failure of Second-Generation Inhibitors: A Single-Arm, Multicenter, Phase 2 Trial.
J Thorac OncolApr 22, 2026 (epub)
Clinical ResearchOncology (Medical)
Jie Huang, Gang Chen, Zhehai Wang et al.
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In 30 seconds
This single-arm, phase 2 trial evaluated deulorlatinib (TGRX-326) in 158 patients with ALK-positive NSCLC who had previously failed second-generation inhibitors. The study found an objective response rate (ORR) of 43.7% and a median progression-free survival (PFS) of 11.1 months, indicating promising antitumor activity and a favorable safety profile.
Key findings
- The IRC-assessed ORR was 43.7% (95% CI, 35.8-51.8).
- The median PFS was 11.1 months (95% CI, 8.3-13.7).
- In patients with measurable CNS metastases, the intracranial ORR was 55.8% (95% CI, 39.9-70.9).
- Treatment-related adverse events occurred in 96.3% of patients, with 47.2% being grade ≥3.
Why it matters
The findings suggest that deulorlatinib may provide a new treatment option for patients with advanced ALK-positive NSCLC who have exhausted second-generation therapies, particularly those with specific mutations.