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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.

LORVIQUA was designed to have improved Blood-Brain penetration to address the challenge of CNS progression head on1,2* Updated efficacy data, including intracranial activity, from an unplanned analysis after 3 years of follow-up1Finding 1: CNS progression delayed in nearly all LORVIQUA-treated patients at 3 years1,†
  • In the intention-to-treat population, the percentage of patients who did not experience CNS progression was 92.3% with LORVIQUA and 37.7% with crizotinib (HR, 0.08; 95% CI, 0.04-0.17)1
 Time to intracranial progression by BICR at 24 and 36 months
(ITT population, N=296)1

Data cutoff: 20 September 2021.1

Finding 2: Longer time to Intracranial progression in patients with or without CNS metastases at baseline1,†

With CNS metastases

  • In patients with CNS metastases at baseline (N=76), the percentage of patients without CNS progression at 36 months was 72.8% with LORVIQUA, compared with all patients who progressed with crizotinib before 24 months (HR, 0.10; 95% CI, 0.04-0.27)1
 Time to intracranial progression by BICR in patients with CNS metastases at baseline at 24 and 36 months (N=76)1

Data cutoff: 20 September 2021.1

Without CNS metastases

  • In patients without CNS metastases at baseline (N=220), the percentage of patients without CNS progression at 36 months was 99.1% with LORVIQUA and 49.8% with crizotinib (HR, 0.02; 95% CI, 0.002-0.136)1
  • In this population, Of 112 patients without baseline brain metastases, treated with LORVIQUA, only one patient developed new intracranial lesions.
 Time to intracranial progression by BICR in patients without CNS metastases at baseline at 24 and 36 months (N=220)1

Data cutoff: 20 September 2021.1

Finding 3: Compelling CNS efficacy in patients with measurable CNS metastases at baseline (N=31)1,† Intracranial ORR (N=31)a

aIntracranial response was assessed by an independent committee using modified RECIST, version 1.1.2
Data cutoff: 20 September 2021.1

  • Median IC-DoR: Not reached (95% Cl, NR-NR) with LORVIQUA vs 10 months (95% Cl, 9-11) with crizotinib1
  • Median duration of intracranial response with baseline brain metastases in months: NR (95% CI) (NR–NR) with LORVIQUA  vs 10·2 (9·4–11·1) with XALKORI 
  • Median duration of intracranial response with measurable and non measurable baseline brain metastases in months: NR (95% CI) (NR–NR) with LORVIQUA  vs 7·3 (3·7–9·3) with XALKORI 
*The primary endpoint of PFS was met in the CROWN trial 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.2 An unplanned follow-up analysis was performed at a median follow-up for PFS of approximately 37 months for patients on LORVIQUA (29 months for patients on crizotinib) to confirm the effect of LORVIQUA relative to crizotinib with longer follow up.†Unplanned analysis; no formal hypothesis testing was performed given that the PFS endpoint was previously met in the CROWN trial primary analysis; results are presented descriptively since the Type I error was already spent at the primary analysis.BICR=blinded independent central review; CNS=central nervous system; HR=hazard ratio; IC-DoR=intracranial duration of response; IC-ORR=intracranial objective response rate; ITT=intention to treat; RECIST=Response Evaluation Criteria in Solid Tumours.References:Solomon B, Bauer T, Mok T, 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, ramdomised, open-label CROWN study. Lancet Respir Med 2023;11:354-66Shaw 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.Efficacy
LORVIQUA safety profile
 Review the safety Loading
PP-LOR-IRL-0131. May 2024 Legal Category S1A Further information available on request

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