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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.

First-line 36-month overall efficacy**Updated efficacy data, including intracranial activity, from an unplanned analysis after 3 years of follow-up1Finding 1:
3 year progression-free survival was 64% (95% CI 55–71) in the LORVIQUA group1
  • Median progression-free survival by blinded independent central review was not reached  for LORVIQUA and 9·3 months for XALKORI
  • The estimated proportion of patients in the LORVIQUA group who were alive without disease progression at 2 years  was 68% and at 3 years was 64%
  • The proportion of patients in the crizotinib group who were alive without disease progression at 2 years was 22% and at 3 years was 19%
 Progression-free survival by BICR at 24 and 36 months (ITT population, N=296)1

Data cutoff: 20 September 2021.1

  • 73% reduction in risk of progression or death with LORVIQUA vs crizotinib (HR, 0.27; 95% Cl, 0.18-0.39), as assessed by BICR1
Finding 2: Patients with CNS metastases at baseline experienced improved progression free survival with LORVIQUA1
  • Among patients with baseline brain metastases (measurable and non-measurable), the HR for progression-free survival by BICR favoured LORVIQUA over Crizotinib. 
  • The proportion of patients in the LORVIQUA group who were alive without disease progression at 2 years was 62% (95% CI 43–76) and at 3 years was 50% (32–66)
  •  The proportion of patients in the Crizotinib group who were alive without disease progression was not evaluable. 
 Progression-free survival by BICR in patients with CNS metastases at baseline at 24 and 36 months (N=76)1

Data cutoff: 20 September 2021.1

  • 79% reduction in risk of progression or death with LORVIQUA vs crizotinib (HR, 0.21; 95% Cl, 0.10-0.44), as assessed by BICR1
Finding 3: Patients without CNS metastases at baseline experienced improved progression free survival with LORVIQUA1
  • Patients without baseline brain metastases, the  HR for progression-free survival by BICR favoured LORVIQUA over Crizotinib. 
  • The proportion of patients in the LORVIQUA group who were alive without disease progression at 2 years was 70% (95% CI 61–78) and at 3 years was 68% (58–76)
  • The proportion of patients in the Crizotinib group who were alive without disease progression at 2 years was 26% (17–36) and at 3 years was 23% (14–33). 
Progression-free survival by BICR in patients without CNS metastases at baseline at 24 and 36 months (N=220)1

Data cutoff: 20 September 2021.1

  • 71% reduction in risk of progression or death with LORVIQUA vs crizotinib (HR, 0.29; 95% Cl, 0.19-0.44), as assessed by BICR1
Finding 4: The proportion of patients with a confirmed objective  response as assessed by blinded independent central review was greater with lorlatinib than with crizotinib1,† ORR (ITT population, N=296)a

aDefined as confirmed complete response or partial response as assessed by BICR.1,
Data cutoff: 20 September 2021.1

  • Median DoR: Not reached (95% Cl, NR-NR) with LORVIQUA vs 9.6 months (95% Cl, 9.0-12.9) with crizotinib1
References*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.3 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; DoR=duration of response; HR=hazard ratio; ITT=intention to treat; NR=not reached; ORR=objective response rate; PFS=progression-free survival; 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;11:354-66Efficacy
LORVIQUA safety profile
 Review the safety
PP-LOR-IRL-0070 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)
 

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