ALECENSA® (alectinib) Significantly Reduced the Risk of CNS as the First Site of Progression

Primary Analysis

ALK+ mNSCLC has a propensity to metastasize to the brain 2

  • The efficacy of ALECENSA was evaluated in delaying tumors from spreading to or growing in the CNS as the first site of progression alone or with concurrent systemic progression (time to cause-specific CNS progression) 1-3,17
    • This analysis was conducted to separate the effect of ALECENSA on CNS progression from systemic
      progression or death
    • Patients who first progressed systemically, and patients with death prior to CNS or systemic progression (ALECENSA n=47; crizotinib n=42),a were not included as events

Percentage of Patients With CNS as the First Site of Progression (Including Those Who Had Concurrent Systemic Progression) 1,3 | IRC

ALECENSA® (alectinib) vs Crizotinib Patients with CNS as the First Site of Progression

84% reduction in risk of tumors spreading to or growing in the CNS as the first site of progression (HR=0.16 [95% CI: 0.10, 0.28]); P<0.0001b

Safety Profile 

Exploratory Subgroup Analysis of Patients With CNS as the First Site of Progression (Including Those Who Had Concurrent Systemic Progression) 16 | IRC

ALECENSA® (alectinib) vs Crizotinib CNS Progression Regardless of CNS Metstases at Baseline

All exploratory analyses are descriptive in nature. Subgroups were not powered to show differences between treatment arms. 15

aSystemic progression without prior CNS progression (ALECENSA n=36; crizotinib n=33); death prior to CNS or systemic progression (ALECENSA n=11; crizotinib n=9). 3 bCause-specific HR and 95% CI were estimated by Cox model where patients with competing events (systemic progression and death prior to CNS or systemic progression) were censored at the time of these events. P-values were estimated from two-sided stratified cause-specific log-rank tests. 17 cExcludes 1 patient in the ALECENSA arm with no CNS metastases by IRC who had received prior radiotherapy. 16

ALECENSA Delivered Durable CNS Responses 

Exploratory Analysis of CNS Responses in Patients With Measurable CNS Metastases at Baseline 1 | IRC 

CNS Response Rates ALECENSA® (alectinib) vs Crizotinib in Patients With CNS Metastases
  • 59% of patients experienced a CNS response that lasted for a year or more with ALECENSA vs 36% of patients with crizotinib 1

All exploratory analyses are descriptive in nature. Subgroups were not powered to show differences between treatment arms. 15

1L=first-line; CI=confidence interval; CNS=central nervous system; CR=complete response; HR=hazard ratio; IRC=Independent Review Committee; ORR=objective response rate; PFS=progression-free survival.

Next: 1L Safety Profile
Alectinib (ALECENSA) NCCN Recommendation Category 1 Preferred

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend alectinib (ALECENSA) as a treatment option for first-line ALK+ metastatic NSCLC (Category 1, Preferred). 4*†

*When an ALK rearrangement is discovered prior to first-line systemic therapy.
†The NCCN Guidelines for NSCLC provide recommendations for individual biomarkers that should be tested and recommend testing techniques, but do not endorse any specific commercially available biomarker assays.

1L PFS Results

View PFS results vs crizotinib from the head-to-head ALEX trial.

View Data

Dosing and Administration

Learn about dosing and monitoring for ALECENSA.

View ALECENSA Dosing

Financial Support for Patients

Learn more about ALECENSA patient and practice resources.

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