Drug updated on 9/4/2024
| Dosage Form | Tablet (oral; 25 mg, 100 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
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Summary
- Lorbrena (lorlatinib) 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.
- This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
- Progression-Free Survival (PFS): Lorlatinib demonstrated the highest probability of favorable PFS among ALK inhibitors globally, especially in patients with baseline brain metastases, while alectinib was notably superior in Asian patients.
- Overall Survival (OS): Alectinib significantly prolonged OS compared to crizotinib and showed the best OS among all ALK inhibitors globally, with no significant difference in OS observed between lorlatinib and crizotinib due to limited follow-up.
- Objective Response Rate (ORR): Lorlatinib exhibited the highest ORR among global patients, with alectinib following closely, and was significantly more effective than crizotinib in achieving the best ORR.
- Lorlatinib had a high incidence of grade 3-5 adverse events (91.6%), including hypertriglyceridemia, hypercholesterolemia, weight gain, cognitive effects, and mood effects, making it one of the least safe ALK inhibitors. Conversely, alectinib demonstrated the lowest rate of grade 3-4 adverse events (16.2%), followed by crizotinib (46.4%) and brigatinib (63.7%).
- Alectinib was notably effective and had the best safety profile for patients with baseline brain metastases and crizotinib-resistant patients. In the Asian population, alectinib and ensartinib had lower rates of severe adverse events compared to other ALK inhibitors.
- There is no population-type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Lorbrena (lorlatinib) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| A pragmatic guide for management of adverse events associated with lorlatinib. | 2024 | Lung Cancer |
| Regimen Reference Order – THOR – lorlatinib. | 2023 | Cancer Care Manitoba |
| Therapy for stage IV non–small-cell lung cancer with driver alterations: ASCO living guideline. | 2022 | Journal of Clinical Oncology |
| Non–small cell lung cancer, version 3.2022. | 2022 | Journal of the National Comprehensive Cancer Network |
| Consensus recommendations for management and counseling of adverse events associated with lorlatinib: a guide for healthcare practitioners. | 2020 | Advances in Therapy |
| The Japanese Lung Cancer Society guideline for non-small cell lung cancer, stage IV. | 2019 | International Journal of Clinical Oncology |