ALECENSA® (alectinib) Was Studied in a Head-to-Head Superiority Trial vs Crizotinib

ALEX: Global, Open-Label, Phase 3 Trial 1,2 

ALECENSA® (alectinib) head-to-head Superiority clinical trial design vs Crizotinib

PRIMARY ENDPOINT 1:

  • PFS (INV)b

ADDITIONAL EFFICACY ENDPOINTS 1:

  • PFS (IRC)b
  • Time to CNS progression (IRC)b
  • ORR (IRC)
  • DOR (IRC)
  • OS (INV)

EXPLORATORY ENDPOINTS 1:

  • CNS ORR in patients with CNS metastases at baseline (IRC)
  • CNS DOR in patients with CNS metastases at baseline (IRC)

STRATIFICATION FACTORS 1:

  • ECOG PS (0/1 vs 2)
  • Race (Asian vs non-Asian)
  • CNS metastases at baseline (yes vs no)

aPatients were required to have an ECOG PS of 0-2 and ALK+ NSCLC as identified by the VENTANA ALK (D5F3) CDx assay.
bAssessed according to RECIST v1.1.

Baseline Characteristics Were Well Balanced Between Treatment Arms

Baseline Characteristics in ITT Population 2

ALECENSA® (alectinib) vs Crizotinib baseline characteristics

1L=first-line; CNS=central nervous system; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; INV=Investigator; IRC=Independent Review Committee; ITT=intention to treat; ORR=objective response rate; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors.

Next: 1L PFS
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.

1L PFS Results

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

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CNS Efficacy in 1L ALK+ mNSCLC

Learn more about CNS efficacy with ALECENSA.

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1L Safety Profile

Learn about the 1L safety profile with ALECENSA.

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