Drug updated on 3/28/2024
| Dosage Form | Tablet (oral; 25 mg, 100 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Summary
- Lorlatinib (Lorbrena) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
- A systematic review and meta-analysis involving nine studies showed that lorlatinib conferred the best progression-free survival among seven first-line treatments, including ensartinib, brigatinib, crizotinib, alectinib, ceritinb and pemetrexed-based chemotherapy.
- In terms of safety profile in treating ALK-positive NSCLC patients with brain metastases at baseline or Asian population subgroup considerations; lorlatinb demonstrated superior efficacy but poorer safety compared to other drugs like alectinb which had better overall survival rate and safety profile while ensartinb was found most effective in Asians.
- Another study comparing toxicity profiles across six different ALK-Tyrosine Kinase Inhibitors revealed that all-grade adverse events were common across all inhibitors but grade 3-4 adverse events were highest for Lorlatinb at 91.6% followed by Ceritinab at 78.3%, Ensartinb at 75.6%, Brigatinab at 63.7% Crizotinub at 46.4% and lowest for Alectnib at 16.2%.
- The economic evidence from nineteen cost-effectiveness analysis studies suggests that despite recent increases in treatment costs due to advances in therapy options such as Lorbrena (Lorlatn), it may still be considered a cost-effective option especially when used as first line treatment against locally advanced or metastic ALK+ NSCLC.
- A network meta-analysis conducted on twelve eligible trials suggested that third-generation inhibitor Lorlatnb has potentially longer progression free survival rates than second generation inhibitors like Alecnitband Brigtanbin particularlly in patients with brain metastases, however it also showed higher rates of serious adverse events.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Lorbrena (lorlatinib) Prescribing Information. | 2021 | Pfizer Inc., New York, NY |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Non–small cell lung cancer, version 3.2022. | 2022 | Journal of the National Comprehensive Cancer Network |
| Therapy for stage iv non–small-cell lung cancer with driver alterations: ASCO living guideline. | 2022 | Journal of Clinical Oncology |
| The Japanese Lung Cancer Society guideline for non-small cell lung cancer, stage IV. | 2019 | International Journal of Clinical Oncology |
| SEOM clinical guidelines for the treatment of non-small cell lung cancer (2018). | 2018 | Clinical and Translational Oncology |