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OverviewStarting Strong in 1LAbout LORVIQUA®Study Design1L study design2L+ study designEfficacy1L overall efficacy1L CNS efficacy1L 5-Year overall efficacy1L 5-Year CNS efficacy2L+ efficacySafetyPooled Safety: all lines1L safety2L+ safetyDosing & Therapy ManagementOnce-daily dosingARs of clinical interestTherapy managementResourcesMaterialsVideos
Prescribing Information 
>5 YEARS OF PFS
in 1L ALK+ aNSCLC with LORVIQUA®1*†

At 5 years1
LorviquaLorviqua Progression 92%

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  • The safety profile of LORVlQUA® was consistent with that in prior analysis. No new safety signals emerged after 5 years.1

    NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and ESMO guidelines recommend lorlatinib (LORVIQUA®) as one of the preferred first-line options forALK+ aNSCLC2,3
  • LORVIQUA® offers >5 years PFS in 1L ALK+ aNSCLC, the longest PFS ever reported in advanced lung cancer (INV-assessed)1

Example


LORVIQUA® as a monotherapy is indicated for4: 

The treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.

The treatment of adult patients with ALK-positive advanced NSCLC whose disease has progressed after:
  • alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or

  • crizotinib and at least one other ALK TKl.
LORVIQUA® efficacy
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*The primary endpoint of PFS was met in the CROWN trial BICR-assessed primary analysis (median follow-up for PFS: 18.3 months for patients receiving LORVIQUA® and 14.8 months for patients receiving crizotinib); median PFS was not estimable for the LORVIQUA® arm. An unplanned INV- assessed follow-up analysis was performed at a median follow-up for PFS of approximately 60 months for patients on LORVIQUA® (55 months for patients on crizotinib) to confirm the effect of LORVIQUA® relative to crizotinib with longer follow-up.1,5†
tLIMITATIONS: The results of this unplanned, investigator-assessed analysis are descriptive. No formal hypothesis testing was performed given that the PFS endpoint was previously met in the CROWN trial primary analysis; results are presented descriptively.1

1L=first-line; ALK=anaplastic lymphoma kinase; ALK+=anaplastic lymphoma kinase-positive; aNSCLC=advanced non-small cell lung cancer; BICR=blinded independent central review; CI=confidence interval; CNS=central nervous system; ESMO=European Society for Medical Oncology; HR=hazard ratio; INV=investigator; PFS=progression-free survival.


ReferencesReferences:
1. Solomon BJ, Liu G, Felip E, et al. Lorlatinib versus crizotinib in patients with advanced ALK-positive non-small cell lung cancer: 5-year outcomes from the phase III CROWN study.JCO 42, 3400-3409(2024). Doi:10.200/JCO.24.00581.
2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 12, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
3. Hendriks LE, Kerr KM, Menis J, et al. Oncogene-addicted metastatic non-small-cell lung cancer; ESMO Clinical Practice Guideline for diagnosis, treatment, and follow-up.Ann Oncol. 2023;34(4):339-357.
4. Pfizer. LORVIQUA (lorlatinib) Summary of Product Characteristics
5. Shaw AT, Bauer TM, de Marinis F, et al; CROWN Trial Investigators. First-line lorlatinib or crizotinib in advancedALK-positive lung cancer.N Engl J Med. 2020;383(21):2018-2029
PP-LOR-IRL-0175 | AUG2025

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