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AboutStudy Design1L study design2L+ study designEfficacy1L overall efficacy1L CNS efficacy1L 36-month overall efficacy1L 36-month CNS efficacy2L+ efficacySafetyPooled Safety: all lines1L safety2L+ safetyDosing & Therapy ManagementDosingTherapy management

The information on this website is based on data from adult patients with ALK-positive advanced NSCLC (anaplastic lymphoma kinase positive advanced non small cell lung cancer) treated with LORVIQUA▼(lorlatinib), produced in line with the LORVIQUA (lorlatinib) Summary of Product Characteristics.
LORVIQUA (lorlatinib) Prescribing Information click here.
▼LORVIQUA is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. Adverse event reporting information can also be found at the bottom of the page.

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
Scroll left to view table
Characteristic EXP3B
(n=28)		 EXP4–5
(n=111)
Prior therapy for NSCLC 1 prior 2nd-generation
ALK TKI ± CT		 ≥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
Sex
Female 16 (57%) 62 (56%)
Male 12 (43%) 49 (44%)
Race
White 7 (25%) 59 (53%)
Black 1 (4%) 0
Asian 16 (57%) 37 (33%)
Other 1 (4%) 5 (5%)
Unspecifiede 3 (11%) 10 (9%)
ECOG PS
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
 Discover the data Loading
PP-LOR-IRL-0067 February 2024 Legal Category S1A Further information available on request

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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