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 2018.2
a 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.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.

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)30649-1
Efficacy
LORVIQUA safety profile
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