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Study 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
Prescribing Information 

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.

Second-line & later efficacyLORVIQUA showed substantial overall and intracranial activity both in treatment-naïve patients with ALK-positive Advanced NSCLC, and in those who had progressed on Crizotinib, second-generation ALK tyrosine kinase inhibitors, or after up to three previous ALK tyrosine kinase inhibitors1,2
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Efficacy parameter 1 prior 2nd-generation
ALK TKIa ± CT (EXP3B)
(n=28)		 ≥2 prior ALK TKIs ± CT
(EXP4–5) (n=111)
ORRb 42.9% 39.6%
95% CI 24.5-62.8% 30.5-49.4%
CR (n) 1 2
PR (n) 11 42
Median DoR 5.6 months 9.9 months
95% CI 4.2 months-NR 5.7-24.4 months
Median PFS 5.5 months 6.9 months
95% CI 2.9-8.2 months 5.4-9.5 months
Adapted from LORVIQUA SmPC
Data cutoff: 2 February 2018.2

Adapted from LORVIQUA SmPC, 2022.
Data cutoff: 2 February 2018.2

In patients who received at least one prior 
ALK TKI, LORVIQUA demonstrated compelling intracranial efficacy1,c
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Efficacy parameter 1 prior 2nd-generation
ALK TKIa ± CT (EXP3B)
(n=9)		 ≥2 prior ALK TKIs ± CT
(EXP4–5) (n=48)
IC-ORRb 66.7% 52.1%
95% CI 29.9%-92.5% 37.2%-66.7%
CR (n) 2 10
PR (n) 4 15
Median duration of IC response NR 12.4 months
95% CI 4.1 months-NR 6.0 months-NR
Adapted from LORVIQUA SmPC
Data cutoff: 2 February 2018.2

Adapted from LORVIQUA SmPC, 2022.
Data cutoff: 2 February 2018.2

Consistent responses were observed irrespective of previous 2nd-generation ALK TKI received3
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Efficacy parameter Alectinib (n=62) Ceritinib (n=47) Brigatinib (n=8)
Confirmed ORR 37.1% 40.4% 37.5%
95% CI 25·2%–50·3% 26·4%–55·7% 8·5%–75·5%
Confirmed Intracranial ORR 43.2%  54.1% 40.0%
5.3%-85.3%
95% CI 27.1% - 60.5%  36.9%-70.5%
References:Adapted from Supplement to: 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; published online Nov 6. http://dx.doi.org/10.1016/S1470-2045(18)30649-1
Data cutoff: 2 February 2018.2a Alectinib, brigatinib, or ceritinib.1
b Per ICR.1
c In patients with at least one measurable brain metastasis at baseline.1
d Kaplan-Meier estimate.2
e Estimates for progression-free survival duration of response and duration of IC response are not calculated due to the small number of patients who received brigatinib as the last second-generation ALK TKI before lorlatinib.2ALK=anaplastic lymphoma kinase; CNS=central nervous system; CR=complete response; CT=chemotherapy; 
DoR=duration of response; EXP=expansion cohort; ICR=independent central review; NC=not calculated; NR=not reached; ORR=objective response rate; PFS=progression-free survival; PR=partial response; TKI=tyrosine kinase inhibitor.

Adapted from Besse B, et al. ASCO 2018.
Data cutoff: 2 February 2018.2

aAlectinib, brigatinib, or ceritinib.1

bPer ICR.1

cIn patients with at least one measurable brain metastasis at baseline.1

dKaplan-Meier estimate.2

eEstimates for progression-free survival duration of response and duration of IC response are not calculated due to the small number of patients who received brigatinib as the last second-generation ALK TKI before lorlatinib.2

ALK=anaplastic lymphoma kinase; CNS=central nervous system; CR=complete response; CT=chemotherapy; 
DoR=duration of response; EXP=expansion cohort; ICR=independent central review; NC=not calculated; NR=not reached; ORR=objective response rate; PFS=progression-free survival; PR=partial response; TKI=tyrosine kinase inhibitor.

References:1. Pfizer. LORVIQUA (lorlatinib) Summary of Product Characteristics. 2. Besse B, Bauer M, et al. Lorlatinib in patients with ALK-positive non-small-cell lung
cancer: results from a global phase 2 study. Lancet Oncol 2018; 19: 1654–67
3. Supplement to: 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; published online Nov 6. http://dx.doi.org/10.1016/S1470-2045(18)30649-1Efficacy
LORVIQUA safety profile
 Review the safety Loading
PP-LOR-IRL-0072 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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