ALECENSA® (alectinib) Was Studied in a Head-to-Head Superiority
Trial vs Crizotinib
ALEX: Global, Open-Label, Phase 3 Trial
1,2
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
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.
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.
CNS Efficacy in 1L ALK+ mNSCLC
Learn more about CNS efficacy with ALECENSA.
1L Safety Profile
Learn about the 1L safety profile with ALECENSA.