LORVIQUA® (Lorlatinib) | 1L CNS Efficacy

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Overview

Starting Strong in 1L

About LORVIQUA®

Study Design

1L study design

2L+ study design

Efficacy

1L overall efficacy

1L CNS efficacy

1L 5-Year overall efficacy

1L 5-Year CNS efficacy

2L+ efficacy

Safety

Pooled Safety: all lines

1L safety

2L+ safety

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Once-daily dosing

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LORVIQUA® was designed to have improved Blood-Brain Barrier penetration to address the challenge of CNS Progression head on^1,2,3

LORVIQUA® showed compelling CNS efficacy in patients with and without brain metastases, both in terms of response and duration^1,2,3

Intracranial Overall Response in patients with measurable CNS lesions at baseline¹

Intracranial ORR (N=30)^a,b

^aIntracranial response was assessed by an independent committee using modified RECIST, version 1.1²
^bPatients with measurable CNS metastases at baseline.²
Data cutoff: 20 March 2020.²

^aIntracranial response was assessed by an independent committee using modified RECIST, version 1.1^2
bPatients with measurable CNS metastases at baseline.²
Data cutoff: 20 March 2020²

Median IC-DoR:Not estimable (95% Cl, NE-NE) with LORVIQUA® vs 10 months (95% CI, 9-11) with crizotinib¹

CNS progression delayed in nearly all LORVIQUA® - treated patients at 1 year²

Time to intracranial progression by BICR at 12 months (ITT population, N=296)²

References

Graph adapted from Shaw AT, Bauer TM, de Marinis F, et al; CROWN Trial Investigators. First-line lorlatinib or crizotinib in advanced ALK-positive lung cancer. N Engl J Med.2020; 383(21): 2018-2029

1L=first-line;2L=second-line;BICR=blinded independent central review; CNS=central nervous system; HR=hazard ratio; IC-DoR=intracranial duration of response; IC-ORR=intracranial objective response rate; INV=investigator; ITT=intention to treat;PFS=progression-free survival. RECIST=Response Evaluation Criteria in Solid Tumours

References

References:

1. Pfizer. LORVIQUA® (lorlatinib) Summary of Product Characteristics.

2. Shaw AT, Bauer TM, de Marinis F, et al; CROWN Trial Investigators. First-line lorlatinib or crizotinib in advanced ALK-positive lung cancer. N Engl J Med.2020;383(21):2018-2029.
3. Solomon BJ, Bauer TM, et al. Efficacy and safety of first-line lorlatinib versus crizotinib in patients with advanced ALK-positive non-small cell lung cancer: updated analysis of data from the phase 3, randomised, open-label CROWN study. Lancet Respir Med 2023;11:354-66

Efficacy

LORVIQUA® safety profile

Review the safety

PP-LOR-IRL-0173 | AUG2025

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PP-UNP-IRL-0937. July 2025

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