saturn: a double-blind, randomized, phase iii study of maintenance erlotinib versus placebo...

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