LORVIQUA in second-line and later treatment of ALK+ advanced NSCLC1
  • LORVIQUA was evaluated as a second-line or later treatment option. The study was a single-arm, multicentre, phase 1/2 study of 100 mg LORVIQUA in previously treated patients with ALK+ advanced NSCLC1,2
  • The study included several cohorts, of which EXP3B, EXP4, and EXP5 are covered by the LORVIQUA indication1
  • Brain metastases were well represented across cohorts1:
    • EXP3B 46% (n=13); EXP4–5 75% (n=83) 
Baseline patient characteristics1
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Characteristic EXP3B
Prior therapy for NSCLC 1 prior 2nd-generation
≥2 prior ALK TKIsd ± CT
Age, years
Median (IQR) 54.0 (46.5-64.0) 51.0 (43.0-59.0)
Mean (SD) 55.0 (11.6) 51.9 (11.5)
Range 33-77 29-83
Female 16 (57%) 62 (56%)
Male 12 (43%) 49 (44%)
White 7 (25%) 59 (53%)
Black 1 (4%) 0
Asian 16 (57%) 37 (33%)
Other 1 (4%) 5 (5%)
Unspecifiede 3 (11%) 10 (9%)
0 15 (54%) 46 (41%)
1 13 (46%) 59 (53%)
2 0 6 (5%)
Brain metastases
Present at baselinef 13 (46%) 83 (75%)
ReferencesAdapted from Solomon BJ, et al. Lancet Oncol. 2018.aTreatment continued until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, or death. Treatment beyond objective progression was allowed if the patient derived clinical benefit (according to the investigator’s discretion).1bObjective tumour response (defined as confirmed complete response or partial response) according to modified RECIST version 1.1, as assessed by ICR.1cIntracranial tumour response (defined as confirmed complete response or partial response) according to modified RECIST version 1.1, which allowed for up to five CNS target lesions, as assessed by ICR.1dLines of therapy; if the same TKI was given twice, it was counted as two previous lines of treatment.1eIn France, information about race was not allowed to be collected per local regulations.1fBy independent central review; includes measurable and non-measurable CNS lesions at baseline.1ALK=anaplastic lymphoma kinase; CNS=central nervous system; CT=chemotherapy; DoR=duration of response; ECOG=Eastern Cooperative Oncology Group Performance Status; EORTC=European Organization for Research and Treatment of Cancer; EXP=expansion cohort; FISH=fluorescence in situ hybridization; ICR=independent central review;  NSCLC=non-small cell lung cancer; PFS=progression-free survival; PROs=patient reported outcomes; QLQ=quality of life questionnaire; RECIST=response evaluation criteria in solid tumours; SD=standard deviation; TKI=tyrosine kinase inhibitor; TTR=time to response.References: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.

Pfizer. LORVIQUA (lorlatinib) Summary of Product Characteristics. 

Study Design 
LORVIQUA 2L+ efficacy
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