Study design | Lorbrena

LORBRENA^TM 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 NSCLC^1,2
The study included several cohorts, of which EXP3B, EXP4 and EXP5 are covered by the LORBRENA™indication^1,2
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.