saturn: a double-blind, randomized, phase iii study of maintenance erlotinib versus placebo...
TRANSCRIPT
SATURN: A double-blind, randomized, phase III study
of maintenance erlotinib versus placebo following non-progression with 1st-line
platinum-based chemotherapy in patients with advanced NSCLC
Rationale for Investigating Erlotinib In Maintenance Setting
Adapted from:1Ciuleanu et al, 2008; 2Fidias et al, 2009; 3Shepherd et al, 2005; 4Gatzemeier et al, 2007.
SATURN Study Design
*Cisplatin/paclitaxel; cisplatin/gemcitabine; cisplatin/docetaxel; cisplatin/vinorelbine; carboplatin/gemcitabine; carboplatin/docetaxel; carboplatin/paclitaxel
Statistical Analyses
Baseline Characteristics
PFS*: All Patients (ITT)
*PFS is measured from time of randomisation into the maintenance phase; assessments were every 6 weeks; ITT=intent-to-treat population
PFS*: EGFR IHC+ Tumours (co-primary end point)
*PFS is measured from time of randomisation into the maintenance phase; assessments were every 6 weeks.
PFS Primary Analysis (ITT)
Best Overall Response
*Stable disease ≥ 6 weeks.
Disease Control Rate ≥12 Weeks*
*CR + PR + SD ≥12 weeks.
Subgroup Analysis of PFS
PFS According to Histology
PFS in EGFR Wild-type Tumours
PFS in EGFR Mutation+ tumours*
*60% censored
Summary of Safety Data
Post-study Treatment
Conclusions