![Page 1: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/1.jpg)
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
![Page 2: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/2.jpg)
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.
![Page 3: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/3.jpg)
SATURN Study Design
*Cisplatin/paclitaxel; cisplatin/gemcitabine; cisplatin/docetaxel; cisplatin/vinorelbine; carboplatin/gemcitabine; carboplatin/docetaxel; carboplatin/paclitaxel
![Page 4: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/4.jpg)
Statistical Analyses
![Page 5: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/5.jpg)
Baseline Characteristics
![Page 6: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/6.jpg)
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
![Page 7: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/7.jpg)
PFS*: EGFR IHC+ Tumours (co-primary end point)
*PFS is measured from time of randomisation into the maintenance phase; assessments were every 6 weeks.
![Page 8: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/8.jpg)
PFS Primary Analysis (ITT)
![Page 9: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/9.jpg)
Best Overall Response
*Stable disease ≥ 6 weeks.
![Page 10: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/10.jpg)
Disease Control Rate ≥12 Weeks*
*CR + PR + SD ≥12 weeks.
![Page 11: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/11.jpg)
Subgroup Analysis of PFS
![Page 12: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/12.jpg)
PFS According to Histology
![Page 13: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/13.jpg)
PFS in EGFR Wild-type Tumours
![Page 14: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/14.jpg)
PFS in EGFR Mutation+ tumours*
*60% censored
![Page 15: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/15.jpg)
Summary of Safety Data
![Page 16: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/16.jpg)
Post-study Treatment
![Page 17: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy](https://reader035.vdocuments.mx/reader035/viewer/2022081603/5697bfe11a28abf838cb3a4a/html5/thumbnails/17.jpg)
Conclusions