SATURN:

1
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
2
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.
3
SATURN Study Design
Cisplatin/paclitaxel cisplatin/gemcitabine
cisplatin/docetaxel cisplatin/vinorelbine
carboplatin/gemcitabine carboplatin/docetaxel
carboplatin/paclitaxel
4
Statistical Analyses
5
Baseline Characteristics
6
PFS All Patients (ITT)
PFS is measured from time of randomisation into
the maintenance phase assessments were every 6
weeks ITTintent-to-treat population
7
PFS EGFR IHC Tumours (co-primary end point)
PFS is measured from time of randomisation into
the maintenance phase assessments were every 6
weeks.
8
PFS Primary Analysis (ITT)
9
Best Overall Response
Stable disease 6 weeks.
10
Disease Control Rate 12 Weeks
CR PR SD 12 weeks.
11
Subgroup Analysis of PFS
12
PFS According to Histology
13
PFS in EGFR Wild-type Tumours
14
PFS in EGFR Mutation tumours
60 censored
15
Summary of Safety Data
16
Post-study Treatment
17
Conclusions