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
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