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Unmet Need Molecular Structure Guidelines Study design Efficacy Safety Dosing and Therapy Management Summary Important Safety Information Abbreviated Prescribing Information
Study design


Second- Line and beyond

LORBRENATM   is a third generation ALK inhibitor that was evaluated in a global, open-label, randomized, multicenter, phase 3 trial2*

The demographic characteristics of the overall study population were: median age 59 years (range: 26 to 90 years), age ≥ 65 years (35%), 59% female, 49% White, 44% Asian and 0.3% Black. The ECOG performance status at baseline was 0 or 1 in 96% of patients. The majority of patients had adenocarcinoma (95%) and never smoked (59%). CNS metastases were present in 26% (n=78) of patients: of these, 30 patients had measurable CNS lesions.2

*Study B7461006; NCT03052608.

 Assessed by BICR according to RECIST v1.1.

BICR: Blinded Independent Central Review; BID=twice daily; CNS: central nervous system; ECOG PS: Eastern Cooperative Oncology Group Performance Status; QD: once daily; RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1; HR: hazard ratio; PFS: progression-free survival.

References:Lorbrena™ EDA leaflet approval date 26/4/2021.Shaw AT, Bauer TM, de Marinis F, et al; CROWN Trial Investigators. N Engl J Med. 2020;383(21):2018-2029.
The LORBRENA™ global registrational study: trial design2
  • This is a single arm, multicenter, Phase II study of 100 mg LORBRENA™ in previously treated patients with ALK+ advanced NSCLC1,2
  • The study included several cohorts, of which EXP3B, EXP4 and EXP5 are covered by the LORBRENA™indication1,2
  • Brain metastases were well represented across cohorts:2
    -    EXP3B 46% (n=13); EXP4-5 75% (n=83)

The LORBRENA™ global registrational study: Baseline characteristics2

*Patients  predominantly received either alectinib or ceritinib as the last ALK TKI ± CI before LORBRENA™.2
Lines of therapy (if the same TKI was given twice, this was counted as two prior lines of treatment).2
In some countries, race was not allowed to be collected per local regulations.2

§By independent central review and includes measurable and non-measurable baseline central nervous system lesions.2

Abbreviations: ALK, Anaplastic lymphoma kinase; CI, Confidence interval; CNS, Central nervous system; CT, Chemotherapy; DoR, Duration of response; ECOG PS, Eastern Cooperative Oncology Group Performance Status; EORTC, European Organization for Research and Treatment of Cancer; FISH, Fluorescence in situ hybridization; ICR, Independent central review; IQR, Interquartile range; NSCLC, Non-small cell lung cancer; PD, Progressive disease; PFS, Progression-free survival; QLQ-C30 – Quality of life Questionnaire – Core 30; QLQ-LC13 – Quality of Life Questionnaire – Lung cancer 13; RECIST, Response Evaluation Criteria in Solid Tumors; SD, Standard deviation; TKI, Tyrosine kinase inhibitor; TTR, Time to response.References:Lorbrena™ EDA leaflet approval date 26/4/2021.Solomon BJ, Besse B, Bauer TM, et al. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol. 2018;19(12):1654–1667.

MOH Approval No: HF0098OA54/062022
Invalidation date: 12/06/2024


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