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Real-world effectiveness of lorlatinib in previously treated ROS1 positive NSCLC patients in Taiwan
Jin-Yuan Shih1, Ching-Yao Yang1, Yung-Hung Luo2
1Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Background:
Lorlatinib is a novel ATP-competitive macrocyclic tyrosine kinase inhibitor (TKI) that targets both anaplastic lymphoma kinase (ALK) and the ROS proto-oncogene 1 (ROS1) rearrangement. ROS1 is a key driver gene found in 1 % of non-small cell lung cancers (NSCLC).
Methods:
This observational study analyzed the effectiveness and safety of lorlatinib in ROS1 positive advanced NSCLC patients who progressed from previous TKI therapy and subsequently received lorlatinib, regardless of chemotherapy. Patients who received lorlatinib under expanded access program in Taiwan before September 2019 were eligible. Patients were followed for at least one year from the first lorlatinib treatment until study completion.
Results:
Ten patients were eligible for this analysis, five males and five females, with a mean age of 47.7 years. Prior to lorlatinib treatment, four patients (40 %) had received only crizotinib, and other six (60 %) had received two or more ROS1 TKIs. The real-world overall response rate (rwORR) was 30 %, and the real-world disease control rate (rwDCR) was 90 %. The intra-cranial rwORR was 29 %, and intra-cranial rwDCR was 86 %. The overall safety profile was consistent with findings from previous clinical and real-world data studies. All patients were still alive at the end of the study. The median progression-free survival was 24.4 months (95 % confidence interval: 3.8-not reached), and 70 % of patients remained progression-free at both 12 and 18 months.
Conclusion:
This real-world analysis highlighted durable effectiveness of lorlatinib in treating NSCLC patients with ROS1 rearrangements in second-line and beyond settings. The safety profile aligned with previous clinical and real-world studies.
Insights
Lorlatinib demonstrates durable effectiveness in advanced non-small cell lung cancer (NSCLC) patients with ROS1 rearrangements, showing a high disease control rate. This real-world study confirms its safety and efficacy in second-line and beyond settings.
Area of Science:
- Oncology
- Pharmacology
- Genetics
Background:
- Lorlatinib is a tyrosine kinase inhibitor (TKI) targeting ALK and ROS1 rearrangements.
- ROS1 rearrangements are found in 1% of non-small cell lung cancer (NSCLC) cases.
- This study focuses on ROS1-positive advanced NSCLC patients previously treated with TKIs.
Purpose of the Study:
- To evaluate the real-world effectiveness and safety of lorlatinib.
- To assess lorlatinib's efficacy in patients with ROS1-positive NSCLC who progressed on prior TKI therapy.
Main Methods:
- Observational study of NSCLC patients receiving lorlatinib.
- Inclusion criteria: ROS1-positive advanced NSCLC, prior TKI therapy, and progression.
- Follow-up for at least one year post-lorlatinib initiation.
Main Results:
- 30% overall response rate (ORR) and 90% disease control rate (DCR).
- Intra-cranial ORR of 29% and DCR of 86%.
- Median progression-free survival of 24.4 months; 70% progression-free at 12 and 18 months.
Conclusions:
- Lorlatinib shows durable effectiveness in second-line and beyond treatment for ROS1-positive NSCLC.
- The drug's safety profile is consistent with prior clinical and real-world data.
- Lorlatinib is a viable option for advanced NSCLC patients with ROS1 rearrangements.
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