ALECENSA® (alectinib) Significantly Improved PFS vs Crizotinib

ALECENSA reduced the risk of progression or death by nearly half 1

PFS at Primary Analysis 1 | IRC

  • Median duration of follow-up: 18.6 months (range: 0.5-29.0 months) for ALECENSA and 17.6 months (range: 0.3-27.0 months) for crizotinib 2
  • ORR: ALECENSA 79% (95% CIb: 72, 85); crizotinib 72% (95% CIb: 64, 79); P=0.1652 1a
    • CR/PR: ALECENSA 13%/66%; crizotinib 6%/66%
  • DOR: Response duration ≥6 months: ALECENSA 82%; crizotinib 57% 1
  • OS: At the time of data cutoff, OS data were not mature 1

PFS at Primary Analysis | INVESTIGATOR

  • In the ITT population, mPFS was not estimable at the time of data cutoff in patients receiving ALECENSA (95% CI: 17.7, NE) compared with 11.1 months in patients receiving crizotinib (95% CI: 9.1, 13.1); HR=0.48 [95% CI: 0.35, 0.66]; P<0.0001 1,2

aStratified by race (Asian vs non-Asian) and CNS metastases at baseline (yes vs no) for Cox model, log-rank test, and Cochran Mantel-Haenszel test, respectively.
bClopper and Pearson exact binomial 95% CI.

Safety Profile

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ALECENSA Reached a mPFS of 34.8 months

PFS at Follow-Up Analysis (Exploratory) 3,14  | INVESTIGATOR

  • Median duration of follow-up: 27.8 months (range: 0.5-38.7 months) for ALECENSA and 22.8 months (range: 0.3-36.7 months) for crizotinib 3,14
    • There was no additional IRC assessment performed at this time 14

The follow-up analysis was performed when approximately 50% of patients in the ALECENSA arm experienced a PFS event and was conducted for the purpose of obtaining a median estimate of PFS. No formal treatment comparisons were performed for the follow-up analysis. 3

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ALECENSA Delivered a Consistent PFS Benefit Across Multiple Prespecified Subgroups

Prespecified Exploratory Subgroup Analysis of PFS 2 | INVESTIGATOR

All exploratory analyses are descriptive in nature. Subgroups were not powered to show differences between treatment arms. Hazard ratios were estimated from unstratified analyses. 15

PFS in Patients With and Without CNS Metastases 

Prespecified Exploratory Subgroup Analysis of PFS 3,16 | INVESTIGATOR

Exploratory Subgroup Analysis of PFS 14 | INVESTIGATOR

All exploratory analyses are descriptive in nature. Subgroups were not powered to show differences between treatment arms. Hazard ratios were estimated from unstratified analyses. 15 

1L=first-line; CI=confidence interval; CNS=central nervous system; CR=complete response; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; HR=hazard ratio; IRC=Independent Review Committee; ITT=intention to treat; mPFS=median progression-free survival; NE=not estimable; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PR=partial response. 

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Alectinib (ALECENSA) NCCN Recommendation Category 1 Preferred

Alectinib (ALECENSA) is THE ONLY preferred first-line treatment option (Category 1) for ALK+ metastatic NSCLC in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) 4*

*When an ALK rearrangement is discovered prior to first-line systemic therapy.

CNS Efficacy in 1L ALK+ mNSCLC

Learn more about CNS efficacy with ALECENSA.

Dosing and Administration

Learn about dosing and monitoring for ALECENSA.

Financial Support for Patients

Learn more about ALECENSA patient and practice resources.