IASLC 18th World Conference on Lung Cancer

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1 Developed in association with the European Thoracic Oncology Platform IASLC 18th World Conference on Lung Cancer October 15 18, 2017 Yokohama, Japan Supported by Eli Lilly and Company. Eli Lilly and Company has not influenced the content of this publication

2 Letter from Prof Rolf Stahel Dear Colleagues It is my pleasure to present this ETOP slide set which has been designed to highlight and summarise key findings in thoracic cancers from the major congresses in This slide set specifically focuses on the IASLC 18th World Conference on Lung Cancer and is available in 4 languages English, French, Chinese and Japanese. The area of clinical research in oncology is a challenging and ever changing environment. Within this environment we all value access to scientific data and research which helps to educate and inspire further advancements in our roles as scientists, clinicians and educators. I hope you find this review of the latest developments in thoracic cancers of benefit to you in your practice. If you would like to share your thoughts with us we would welcome your comments. Please send any correspondence to I would like to thank our ETOP members Drs Solange Peters and Martin Reck for their roles as Editors for prioritising abstracts and reviewing slide content. The slide set you see before you would not be possible without their commitment and hard work. And finally, we are also very grateful to Lilly Oncology for their financial, administerial and logistical support in the realisation of this complex yet rewarding activity. Yours sincerely, Rolf Stahel President, ETOP Foundation Council

3 ETOP Medical Oncology Slide Deck Editors 2017 Focus: advanced NSCLC (not radically treatable stage III & stage IV) Dr Solange Peters Multidisciplinary Oncology Center, Lausanne Cancer Center, Lausanne, Switzerland Focus: other malignancies, SCLC, mesothelioma, rare tumours Dr Martin Reck Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf, Germany

4 Contents Biomarkers and screening Early stage and locally advanced NSCLC Stages I, II and III Advanced NSCLC Not radically treatable stage III and stage IV First line Later lines Other malignancies SCLC, mesothelioma and thymic epithelial tumours

5 Biomarkers

6 MA 05.02: STK11/LKB1 Loss of Function Genomic Alterations Predict Primary Resistance to PD-1/PD-L1 Axis Blockade in KRAS-Mutant NSCLC Skoulidis F, et al Study objective To investigate the impact of STK11 genomic alterations in the efficacy of PD-1/ PD-L1 inhibitors in patients with KRAS mutant and wild-type lung adenocarcinoma Methods Data were retrospectively analysed from patients with lung adenocarcinoma treated with immune checkpoint inhibitors 174 KRAS-mutant lung adenocarcinoma included 146 nivolumab, 19 pembrolizumab, 9 anti-pd-1/pd-l1 + anti-ctla-4 Tumour cell PD-L1 expression was tested using the VENTANA PD-L1 (SP142) and the E1L3N IHC assay TMB was classified as high (TMB-H), intermediate (TMB-I) or low (TMB-L) Skoulidis F et al. J Thorac Oncol 2017;12(suppl):Abstr MA 05.02

7 MA 05.02: STK11/LKB1 Loss of Function Genomic Alterations Predict Primary Resistance to PD-1/PD-L1 Axis Blockade in KRAS-Mutant NSCLC Skoulidis F, et al Key results Patients with KRAS/STK11 co-mutations had poor clinical response ORR: KL 7.4%, KP 35.7% and K-only 28.6% (p= ) Shorter PFS and OS in KL lung adenocarcinoma PFS: KL 1.8 months, KP 3.0 months, K 2.7 months (p=0.0018) OS: KL 6.4 months, KP 16.0 months, K 16.1 months (p=0.0045) STK11 genetic alterations were enriched in TMBI/H lung adenocarcinoma with negative PD-L1 expression Conclusions In KRAS-mutant NSCLC, STK11 loss of function genetic alterations represent a major driver of resistance to PD-1 axis blockade TP53 co-mutations are associated with clinical benefit from PD-1 inhibitor therapy KL, KRAS + STK11/LKB1; KP, KRAS + TP53; K, KRAS only Skoulidis F et al. J Thorac Oncol 2017;12(suppl):Abstr MA 05.02

8 MA 05.04: Distinct Immunosuppressive Microenvironment Determines Poor Prognosis of Nonsmokers with Adenocarcinoma of Non-Small Cell Lung Cancer Kinoshita T, et al Study objective To investigate the prognostic significance of CD8+ TILs according to histological types in resected NSCLC Methods Prognostic significance of CD8+ TILs was studied by immunohistochemical analysis and immune-related gene expression analysis Patients were divided by histological type: adenocarcinoma and nonadenocarcinoma, and by smoking status Kinoshita T et al. J Thorac Oncol 2017;12(suppl):Abstr MA 05.04

9 MA 05.04: Distinct Immunosuppressive Microenvironment Determines Poor Prognosis of Nonsmokers with Adenocarcinoma of Non-Small Cell Lung Cancer Kinoshita T, et al Key results The number of CD8+ T cells was higher in non-adenocarcinoma samples In non-adenocarcinomas, accumulated CD8+ T cells was associated with better prognosis, but the opposite was seen in adenocarcinomas Infiltrating CD8+ T cells in non-adenocarcinoma were well-activated, but were not thoroughly activated in adenocarcinoma Immunosuppressive microenvironment was established in adenocarcinoma in non-smokers Potentially immunosuppressive CD8+ T cells correlated with immunoregulatory T cells and macrophages, and accumulate in adenocarcinomas in non-smokers Conclusion These findings may help to refine personalised immunotherapy strategies in NSCLC Kinoshita T et al. J Thorac Oncol 2017;12(suppl):Abstr MA 05.04

10 MA 05.06: Comparison Study of PD-L1 Immunohistochemistry Assays with 22C3 and 28-8: Analysis on Surgical Specimens of NSCLC Saito T, et al Study objective To characterise two immunohistochemistry assays for PD-L1 (22C3 and 28-8) Methods 420 consecutive cases of completely resected NSCLC 5 μm thick sections stained with PD-L1 IHC 22C3 PharmDx (Dako, Santa Clara, CA) and 28-8 PharmDx (Dako, Santa Clara, CA) Key results Overall, PD-L1 expression was detected in 41.9% of cases Agreement on PD-L1 evaluation differed by cut-off: Correlated well for PD-L1 expression 1% (correlation of 0.850; p=0.886) Suboptimal for higher PD-L1 expression (0.732 for PD-L1 25%; p=0.0005; for PD-L1 50%; p=0.002) Conclusion The PD-L1 overall percentage agreement was fair between 22C3 and 28-9, but agreement was suboptimal with cut-offs 25% and 50% Saito T et al. J Thorac Oncol 2017;12(suppl):Abstr MA 05.06

11 MA 06.08: Lung Cancer Patients with Germline Mutation: A Retrospective Study Shukuya T, et al Study objective To examine the frequency and characteristics of lung cancer patients with germline mutations Methods Retrospective study and chart review of samples from 3,869 patients with lung cancer diagnosed by NGS Key results Seven patients with germline mutations were identified Three had BRCA2 germline mutations, two had germline TP53 mutations (of which one patient also had a PARK2 mutation), one had a BRCA1 mutation, and one had an EGFR mutation Three patients were treated with targeted therapy resulting in partial response (n=2) and SD (n=1) Conclusion Identification of patients with germline mutations through NGS and liquid biopsies offers potential for new targeted therapy Shukuya T et al. J Thorac Oncol 2017;12(suppl):Abstr MA 06.08

12 OA 05.02: Osimertinib vs SoC EGFR-TKI as First-Line Treatment in Patients with EGFRm Advanced NSCLC (FLAURA): Plasma ctdna Analysis Gray JE, et al Study objective To evaluate the concordance between plasma and tumour tissue testing and treatment outcomes based on study entry plasma EGFRm status Key patient inclusion criteria Locally advanced or metastatic NSCLC Osimertinib 80 mg/day PO (n=279) PD Age 18 years (Japan 20 years) Ex19del/L858R mutation No prior systemic anti-cancer/ EGFR-TKI therapy WHO PS (n=556) R 1:1 Stratification Mutation status (Ex19del vs. L858R) Race (Asian vs. non-asian) SoC (gefitinib 250 mg/day or erlotinib 150 mg/day) PO (n=277) PD Primary endpoint PFS (investigator assessment) Secondary endpoint PFS by EGFRm status detectable in plasma ctdna Gray JE et al. J Thorac Oncol 2017;12(suppl):Abstr OA 05.02

13 OA 05.02: Osimertinib vs SoC EGFR-TKI as First-Line Treatment in Patients with EGFRm Advanced NSCLC (FLAURA): Plasma ctdna Analysis Gray JE, et al Key results % agreement of cobas plasma test with tissue test, % (95%CI) Conclusions Tissue Ex19del positive Concordance data were consistent with AURA3 Tissue L858R positive Positive % agreement (sensitivity) 79 (74, 84) 68 (61, 75) Negative % agreement (specificity) 99 (96, 100) 99 (97, 100) Overall concordance 87 (84, 90) 88 (85, 91) High concordance was observed between central tissue and plasma testing for EGFRm in the FLAURA screened population A significant improvement in PFS over SoC was observed in the overall FAS (all patients were tissue EGFRm positive In the plasma ctdna EGFRm-positive subgroup there was also significant improvement in PFS with osimertinib over SoC These data support plasma ctdna EGFRm testing for selecting patients eligible for 1L osimertinib Gray JE et al. J Thorac Oncol 2017;12(suppl):Abstr OA 05.02

14 MA 11.02: Circulating Tumour DNA in Early Stage NSCLC: High Sensitivity Analysis in Low Burden Disease. LUCID Study Update Ruiz-Valdepenas A, et al Study objective To investigate high sensitivity analysis of ctdna in patients with early stage NSCLC Methods Plasma samples collected from early stage NSCLC patients in the LUCID (LUng cancer - CIrculating tumour DNA) study Analysis of multiple mutations in parallel allows detection of very low levels of ctdna Key results Preliminary data show a median number of 306 mutations in tumour exome sequence of 19 patients In the next stage, TAilored Panel Sequencing (TAPAS) will be used to sequence plasma samples with a bespoke patient-specific panel Conclusions These techniques will improve the detection of early stage cancer, detecting low levels of ctdna earlier than previously possible It may also prove useful in identifying the presence of minimal residual disease after radical treatment Ruiz-Valdepenas A et al. J Thorac Oncol 2017;12(suppl):Abstr MA 11.02

15 OA 07.03a: Impact of Tumor Mutation Burden on the Efficacy of Nivolumab or Nivolumab + Ipilimumab in Small Cell Lung Cancer: An Exploratory Analysis of CheckMate 032 Antonio S, et al Study objective To determine whether high tumour mutation burden (TMB) is associated with greater benefit for treatment with nivolumab with or without ipilimumab in patients with SCLC in the CheckMate 032 Methods Patients from CheckMate 032 with paired tumour/whole blood samples and TMB evaluable were included (133 from the nivolumab arm and 78 from the nivolumab + ipilimumab arm) Whole exome sequencing was used to determine TMB which was calculated as the total number of missense mutations in the tumour Patients were divided according to three TMB tertiles based on total number of missense mutations: low 0 to <143; medium 143 to 247; and high 248 Antonio S et al. J Thorac Oncol 2017;12(suppl):Abstr OA 07.03a

16 ORR, % OA 07.03a: Impact of Tumor Mutation Burden on the Efficacy of Nivolumab or Nivolumab + Ipilimumab in Small Cell Lung Cancer: An Exploratory Analysis of CheckMate 032 Antonio S, et al ORR by TMB subgroup n= TMB-evaluable Low TMB Medium TMB High TMB Nivolumab Nivolumab + ipilimumab Antonio S et al. J Thorac Oncol 2017;12(suppl):Abstr OA 07.03a

17 PFS, % OA 07.03a: Impact of Tumor Mutation Burden on the Efficacy of Nivolumab or Nivolumab + Ipilimumab in Small Cell Lung Cancer: An Exploratory Analysis of CheckMate 032 Antonio S, et al PFS by TMB subgroup Nivolumab Nivolumab + ipilimumab 100 Median PFS, months (95%CI) Low TMB Med TMB High TMB 1.3 (1.2, 1.4) 1.3 (1.2, 1.4) 1.4 (1.3, 2.7) 100 Median PFS, months (95%CI) Low TMB Med TMB High TMB 1.5 (1.3, 2.7) 1.3 (1.2, 2.1) 7.8 (1.8, 10.7) No. at risk Low Medium High 1-y PFS 21.2% 1-y PFS NC 1-y PFS 3.1% Time, months y PFS 30.0% 1-y PFS 8.0% 1-y PFS 6.2% Time, months NC, not calculable Antonio S et al. J Thorac Oncol 2017;12(suppl):Abstr OA 07.03a

18 OS, % OA 07.03a: Impact of Tumor Mutation Burden on the Efficacy of Nivolumab or Nivolumab + Ipilimumab in Small Cell Lung Cancer: An Exploratory Analysis of CheckMate 032 Antonio S, et al Median OS, months (95%CI) Nivolumab OS by TMB subgroup Low TMB Med TMB High TMB 3.1 (2.4, 6.8) 3.9 (2.4, 9.9) 5.4 (2.8, 8.0) Nivolumab + ipilimumab Median OS, months (95%CI) 1-y OS 62.4% Low TMB Med TMB High TMB 3.4 (2.8, 7.3) 3.6 (1.8, 7.7) 22.0 (8.2, NR) No. at risk Low Medium High Conclusions 1-y OS 35.2% 1-y OS 26.0% 1-y OS 22.1% Time, months Nivolumab with or without ipilimumab demonstrated improved outcomes in the high vs. low or medium TMB groups and the combination provided greater clinical benefit vs. nivolumab alone in the high TMB subgroup Further investigation and optimisation of TMB as a predictive biomarker is warranted y OS 23.4% 1-y OS 19.6% Time, months Antonio S et al. J Thorac Oncol 2017;12(suppl):Abstr OA 07.03a

19 OA 09.01: Characterizing the Genomic Landscape of EGFR C797S in Lung Cancer Using ctdna Next-Generation Sequencing Piotrowska Z, et al Study objective To investigate the relative frequency of allelic configuration (cis vs. trans) of C797S with respect to T790M in clinical samples Methods Patients with lung adenocarcinoma and an EGFR C797S mutation were selected from the Guardant Health database (n=61, samples=141) All patients had comprehensive ctdna testing using the Guardant360 NGS assay Cis/trans configuration for T790M and C797S was determined using Integrated Genomics Viewer software Piotrowska Z et al. J Thorac Oncol 2017;12(suppl):Abstr OA 09.01

20 OA 09.01: Characterizing the Genomic Landscape of EGFR C797S in Lung Cancer Using ctdna Next-Generation Sequencing Piotrowska Z, et al Key results C797S/T790M occurred in cis configuration in 50/61 (82%) of samples and trans in 6/61 (10%) C797S mutations can be polyclonal; overall, 26/61 (42.6%) patients had 1 C797 clone detected At the time of EGFR C797S emergence, 47/61 (77%) of the patients were receiving osimertinib A separate resistance mechanism co-occurred in the majority of patients with C797S mutations including EGFR amplification in 48% of patients, MET amplification in 16% Conclusions C797S most commonly occurs with T790M in cis, which is associated with resistance to all currently available EGFR TKIs The trans configuration, which may respond to combined 1st/3rd-generation EGFR TKIs, is far less common C797S coexists with other resistance mechanisms in ctdna, underscoring the heterogeneity of resistant cancers Piotrowska Z et al. J Thorac Oncol 2017;12(suppl):Abstr OA 09.01

21 OA 10.01: Detection of EGFR Mutations from Plasma ctdna in the Osimertinib Phase III Trial (AURA3): Comparison of Three Plasma Assays Ahn M-J, et al Study objective To evaluate concordance for the detection of EGFR mutations between plasma ctdna and tissue samples from the AURA3 trial Methods Tumour tissue biopsy samples were taken following progression on 1L EGFR-TKI therapy and assessed by cobas EGFR mutation test. Baseline blood samples for plasma ctdna were analysed using AS-PCR (cobas EGFR Mutation Test v2), ddpcr (Biodesix) and NGS (Guardent Health) Key results T790M Ex19del L858R Positive % agreement Negative % agreement Positive % agreement Negative % agreement Positive % agreement Negative % agreement AS-PCR (n=226) 51% (115/226) NA 85% (132/155) 99% (70/71) 59% (40/68) 100% (158/158) ddpcr (n=208) 57% (118/208) NA 72% (102/142) 100% (66/66) 69% (44/64) 99% (141/143) NGS (n=227) Conclusions 65% (148/227) NA 81% (126/156) 99% (70/71) 62% (42/68) ddpcr and NGS assays were more sensitive than AS-PCR in the detection of plasma T790M Robust correlations were observed between quantitative ddpcr and NGS assays 98% (156/159) Ahn M-J et al. J Thorac Oncol 2017;12(suppl):Abstr OA 10.01

22 EGFR T790M C797S ALK MET ERBB2 KRAS RET BRAF TP53 MYC FGFR1 CDKN2A SMAD4 POM121L12 CDK6 CSMD3 CDK4 CCND1 STK11 FGF19 FGF3 BRCA1 KEAP1 RB1 NTRK1 SPTA1 AKT1 FGF4 APC PIK3R1 OR6F1 NOTCH1 OR4A15 GATA3 FGFR3 OR4C6 OR5L2 KDM5A MTOR SOX2 GFRAL CTNNB1 THSD7A BRCA2 PTEN ARID1A SPOP ERBB3 NAV3 TNR SNTG1 Share, % OA 10.02: Unique Genetic Profiles from Circulating Cell-Free DNA of Cerebrospinal Fluid in Leptomeningeal Metastases of EGFR Mutant NSCLC Jiang B, et al Study objective To explore resistance mechanisms of leptomeningeal metastases (LM) Methods NGS with 168 gene panels using primary tumour, CSF and plasma from patients (n=30) with EGFR mutant NSCLC suspected LM Key results Alterations Synonymous Missense CN del CN amp Indel Nonsense Frameshift Splice site Conclusions CSF cfdna was superior to CSF precipitates and plasma in identifying driver and resistance genes in LM EGFR T790M, CNVs of MET, and TP53 LOH may contribute to LM in NSCLC patients with EGFR mutation Jiang B et al. J Thorac Oncol 2017;12(suppl):Abstr OA 10.02

23 OA 10.05: Non-Invasive Molecular Profiling in NSCLC by Targeted and Whole Exome Analysis of Plasma cfdna Cheng ML, et al Study objective To develop a workflow strategy to enable effective selection of tumour samples for targeted and whole exome sequencing using cfdna Methods Plasma samples were collected from patients with NSCLC (n=20) who had received treatment (including chemotherapy, targeted therapy or immunotherapy) The majority of patients (>70%) had stage III or IV disease cfdna was extracted from plasma and analysis was performed using low-pass shallow whole genome sequencing (swgs) and MSK-IMPACT (targeting over 400 cancer-related genes) Analysis of matched normal was performed for somatic variant calling Cheng ML et al. J Thorac Oncol 2017;12(suppl):Abstr OA 10.05

24 Median allele fraction cfdna exome MAF OA 10.05: Non-Invasive Molecular Profiling in NSCLC by Targeted and Whole Exome Analysis of Plasma cfdna Cheng ML, et al Key results Lung cancer Tumour CNA Yes No MSK-L-017 MSK-L-039 MSK-L-046 MSK-L /20 cfdna samples have high mutant allele fraction Conclusions Molecular profiling using cfdna in lung cancer may identify alterations in patients without sufficient tissue for molecular profiling Using swgs to estimate levels of tumour-derived MAF in cfdna samples can help guide downstream sequencing strategy MAF, mutant allele fraction Genome-wide Z-score cfdna MAF by targeted sequencing Cheng ML et al. J Thorac Oncol 2017;12(suppl):Abstr OA 10.05

25 Disease-free survival, probability OS, probability OA 13.06: Co-Expression of IDO1 and PD-L1 Indicates More Aggressive Features of Lung Adenocarcinoma Kozuma Y, et al Study objective To assess the relationship between indoleamine 2,3-dioxygenase 1 (IDO1) and prognosis in lung adenocarcinoma Methods Samples from 427 patients who underwent surgical resection ( ) were evaluated for IDO1 and PD-L1 expression by immunohistochemistry Key results 1.0 DFS 1.0 OS Conclusion ID01(-)/PD-L1(-): n=145 ID01(-)/PD-L1(+): n=22 ID01(+)/PD-L1(-): n=137 ID01(+)/PD-L1(+): n=123 HR 2.07 (1.46, 2.90) Log-rank p< Time after surgery, years Time after surgery, years IDO1 expression was associated with poor prognosis, and co-expression of PD-L1 and IDO1 was an independent predictor of shorter DFS and OS Kozuma Y et al. J Thorac Oncol 2017;12(suppl):Abstr OA ID01(-)/PD-L1(-): n=145 ID01(-)/PD-L1(+): n=22 ID01(+)/PD-L1(-): n=137 ID01(+)/PD-L1(+): n=123 HR 2.79 (1.81, 4.31) Log-rank p<0.0001

26 Early and locally advanced NSCLC Stages I, II and III

27 OA 01.01: A Randomized Trial of SABR vs Conventional Radiotherapy for Inoperable Stage I Non-Small Cell Lung Cancer: TROG (CHISEL) Ball DL, et al Study objective To investigate the effect of SABR compared with CRT on local progression in patients with inoperable stage I NSCLC Key patient inclusion criteria Stage I (T1-T2a N0) NSCLC Inoperable or refused surgery Tumour 2 cm from bifurcation of lobar bronchi ECOG PS 0 1 (n=101) R 2:1 SABR (54 Gy in 3 fx in 2 weeks or 48 in 4 fx in 2 weeks*) (n=66) Stratification T1 vs. T2a Medically inoperable vs. operable CRT (66 Gy in 33 fx in 6.5 weeks or 50 Gy in 20 fx in 4 weeks) (n=35) PD PD Primary endpoint Time to local failure *Depending on proximity to the chest wall CRT, conventional fully fractionated radiotherapy; Fx, fraction; SABR, stereotactic ablative body radiotherapy Secondary endpoints OS, lung cancer specific survival, toxicities, QoL Ball DL et al. J Thorac Oncol 2017;12(suppl):Abstr OA 01.01

28 Freedom from local failure, % Overall survival, % OA 01.01: A Randomized Trial of SABR vs Conventional Radiotherapy for Inoperable Stage I Non-Small Cell Lung Cancer: TROG (CHISEL) Ball DL, et al Key results Time to local failure OS 100 HR 0.29 (95%CI 0.13, 0.66) p= HR 0.51 (95%CI 0.29, 0.91) p= SABR Conventional radiotherapy Years since registration SABR Conventional radiotherapy Years since registration Conclusions SABR resulted in longer time to local failure, improved OS and was well tolerated SABR should be considered a SoC in patients with inoperable peripheral stage I NSCLC Ball DL et al. J Thorac Oncol 2017;12(suppl):Abstr OA 01.01

29 PL 02.02: Patient-Reported Outcomes with Durvalumab after Chemoradiation in Locally Advanced, Unresectable NSCLC: Data from PACIFIC Hui R, et al Study objective To compare QoL outcomes in patients with unresectable NSCLC who were administered with durvalumab vs. placebo for 12 months in the PACIFIC trial Key patient inclusion criteria Stage III, locally advanced, unresectable NSCLC Not progressed following platinum-based ccrt Aged 18 years Life expectancy 12 weeks WHO PS 0 1 (n=713) R 2:1 Stratification Age Sex Durvalumab 10 mg/kg q2w up to 12 months (n=476) Smoking history Placebo q2w up to 12 months (n=237) PD PD Primary endpoint PFS, OS Secondary endpoints ORR, DoR, safety, PROs Hui R et al. J Thorac Oncol 2017;12(suppl):Abstr PL 02.02

30 PL 02.02: Patient-Reported Outcomes with Durvalumab after Chemoradiation in Locally Advanced, Unresectable NSCLC: Data from PACIFIC Hui R, et al Key results There were no notable differences between treatment arms for global health status/qol, key symptoms or physical function at baseline Key symptom scores remained stable throughout the study in both treatment groups, with no significant changes from baseline Clinically relevant improvements from baseline in dysphagia and alopecia were observed at week 48, regardless of treatment The odds of improvement in appetite loss in the durvalumab group was greater than observed in the placebo group (OR 1.72; 95%CI 1.04, 2.85) Conclusions Treatment with durvalumab following chemoradiation was associated with maintained function and global health status/qol in patients with locally advanced, unresectable NSCLC The satisfactory efficacy and safety profile of durvalumab, in addition to the QoL results observed in the PACIFIC trial supports its clinical value in this setting Hui R et al. J Thorac Oncol 2017;12(suppl):Abstr PL 02.02

31 PL 02.04: SCAT Ph III Trial: Adjuvant CT Based on BRCA1 Levels in NSCLC N+ Resected Patients. Final Survival Results a Spanish Lung Cancer Group Trial Massuti B, et al Study objective To examine outcomes among patients with N+ resected NSCLC when adjuvant chemotherapy is customised by levels of BRCA Low BRCA1: gemcitabine/cisplatin (n=155) Medium BRCA1: docetaxel/cisplatin (n=99) PD / death / toxicity Key patient inclusion criteria R0 resected NSCLC pn1 / pn2 (n=500) R 1:3 Stratification High BRCA1: docetaxel (n=100) Stage, age, histology and type of resection Docetaxel/cisplatin (n=102) PD / death / toxicity Primary endpoint OS Cisplatin 75 mg/m 2 D1; docetaxel 75 mg/m 2 D1; gemcitabine 1250 mg/m 2 D1,8 Secondary endpoints DFS, safety, outcomes by chemotherapy regimens, recurrence pattern, translational research Massuti B et al. J Thorac Oncol 2017;12(suppl):Abstr PL 02.04

32 Probability PL 02.04: SCAT Ph III Trial: Adjuvant CT Based on BRCA1 Levels in NSCLC N+ Resected Patients. Final Survival Results a Spanish Lung Cancer Group Trial Massuti B, et al Key results Median survival was 82.4 months in the experimental arms and 69.3 months in the control arm Survival was similar between experimental groups Experimental group by treatment Median survival: Cisplatin/gemcitabine: 74 months Cisplatin/docetaxel: 80.5 months Docetaxel: 80.2 months 5-year survival rate: Cisplatin/gemcitabine: 56% Cisplatin/docetaxel: 53% Docetaxel: 60% Conclusion Survival, months Customisation of adjuvant chemotherapy according to BRCA1 levels did not result in significant differences in OS for the overall population in patients with N+ resected NSCLC Massuti B et al. J Thorac Oncol 2017;12(suppl):Abstr PL 02.04

33 MA 17.10: Toxicity Results from the Randomized Phase III NVALT-11 Study of Prophylactic Cranial Irradiation vs. Observation in Stage III NSCLC De Ruysscher DK, et al Study objective To report toxicity of prophylactic cranial irradiation (PCI) in patients with radically treated stage III NSCLC Key patient inclusion criteria Radically treated stage III NSCLC Concurrent or sequential chemo-rt With or without surgery No clinical signs of PD WHO PS 0 2 (2 3 weeks after radical therapy) (n=175) Primary endpoint Proportion of patients developing symptomatic brain metastases a R 1:1 PCI b, dose c decided by physician (n=87) Observation (n=88) Secondary endpoints Time to development neurological symptoms, safety, QoL, OS a Defined as increased intracranial pressure, headache, nausea, vomiting, cognitive, affective disturbances, seizures, focal neurological symptoms; b Within 4 weeks after completion of radical therapy (6 weeks is allowed); c 36 Gy in 18 fractions, 30 Gy in 12, or 30 Gy in 10 De Ruysscher DK et al. J Thorac Oncol 2017;12(suppl):Abstr MA PD PD

34 Proportion brainmetastases free Survival probability MA 17.10: Toxicity Results from the Randomized Phase III NVALT-11 Study of Prophylactic Cranial Irradiation vs. Observation in Stage III NSCLC De Ruysscher DK, et al Key results PCI significantly reduced the incidence of symptomatic brain metastases (7.0% vs. 27.2% with observation only; p<0.001) but had no effect on OS Time to symptomatic brain metastases OS PCI Observation Patient-reported headache (grade 1 2) was more common with PCI (63.2% vs. 40.9%) Physician-rated cognitive and memory disturbances (grade 1 2) were both more common with PCI Conclusion PCI Observation Follow-up time, months Benefits of PCI must be considered against its side effects and lack of effect on survival Follow-up time, months De Ruysscher DK et al. J Thorac Oncol 2017;12(suppl):Abstr MA 17.10

35 OA 16.03: Recurrences and 2 nd Primary Cancers in the IFCT-0302 Trial Assessing a CT-Scan-Based Follow-Up after Lung Cancer Surgery Westeel V, et al Study objective To compare two different follow-up strategies in patients who had undergone complete resection of early stage NSCLC Key patient inclusion criteria Complete resection of a stage I, II, IIIA and T4 (pulmonary nodules in the same lobe), N0-2 NSCLC (TNM 6th edition) (n=1775) Endpoint Recurrence/2 nd primary cancers as reported by investigators *CT scan allowed if symptoms or abnormal X-ray R 1:1 Minimal follow-up (control) History + physical examination, chest X-ray* (n=888) Stratification Centre Stage Histology Perioperative treatments Maximal follow-up History + physical examination, chest X-ray, CT scan + contrast, bronchoscopy (n=887) Westeel V et al. J Thorac Oncol 2017;12(suppl):Abstr OA 16.03

36 Overall survival landmark Overall survival landmark OA 16.03: Recurrences and 2 nd Primary Cancers in the IFCT-0302 Trial Assessing a CT-Scan-Based Follow-Up after Lung Cancer Surgery Westeel V, et al Key results Patients with recurrence at 24 months Patients with NO recurrence at 24 months 1.0 Median OS (95%CI) Maximal surveillance 48.3 (40.3, 62.1) Minimal surveillance 48.4 (38.1, 59.0) p= Maximal surveillance Median OS (95%CI) NR Minimal surveillance (119.3, NR) p= Conclusions Time, months Time, months In the maximal follow-up arm there were more recurrences and more 2nd primary cancers Both for recurrence and 2nd primary cancers there were fewer that were symptomatic, and there was more surgery in the maximal follow-up arm Westeel V et al. J Thorac Oncol 2017;12(suppl):Abstr OA 16.03

37 OA 16.04: Efficacy and Safety of Erlotinib vs Vinorelbine/Cisplatin as Adjuvant Therapy for Stage IIIA EGFR Mutant NSCLC Patients Yue D, et al Study objective To evaluate the efficacy and safety of adjuvant erlotinib vs. vinorelbine + cisplatin in treatment naïve patients with completely resected stage IIIA EGFR mutation positive NSCLC Methods Randomized controlled trial of 102 patients who received erlotinib 150 mg/day for 2 years (n=51) or vinorelbine 25 mg/m 2 D1, 8 + cisplatin 75 mg/m 2 D1, 21 for 4 cycles (n=51) Primary endpoint was 2-year DFS rate; secondary endpoints DFS, OS, safety, QoL and biomarkers Key results In the erlotinib group, 2-year DFS rate was significantly higher (81.35%) than chemotherapy (44.62%; p<0.001) and the median DFS was longer (42.41 months) than chemotherapy (20.96 months; p<0.001) Erlotinib had a more favourable safety profile than chemotherapy Conclusions In patients with R0 resected stage IIIA EGFR-mutant NSCLC erlotinib demonstrates interesting activity Longer follow-up in this curative setting is needed and the role of chemotherapy in that context will need to be defined Yue D et al. J Thorac Oncol 2017;12(suppl):Abstr OA 16.04

38 Advanced NSCLC Not radically treatable stage III and stage IV First line

39 MA 07.01: Patients with ALK IHC-Positive/FISH-Negative NSCLC Benefit from ALK TKI Treatment: Response Data from the Global ALEX Trial Mok TSK, et al Study objective To investigate clinical outcome in a subset of patients with IHC-positive/FISHnegative NSCLC from the ALEX trial Methods This was a retrospective analysis of the ALEX trial Result, n (%) Crizotinib (n=151) Alectinib (n=152) Total (n=303) IHC Positive 151 (100) 152 (100) 303 (100) FISH Positive Negative Unknown 97 (65) 18 (12) 36 (24) 106 (70) 21 (14) 25 (16) 203 (67) 39 (13) 61 (20) Mok TSK et al. J Thorac Oncol 2017;12(suppl):Abstr MA 07.01

40 MA 07.01: Patients with ALK IHC-Positive/FISH-Negative NSCLC Benefit from ALK TKI Treatment: Response Data from the Global ALEX Trial Mok TSK, et al Key results ALK IHC-positive/FISH-positive ALK IHC-positive/FISH-negative Crizotinib (n=97) Alectinib (n=106) Crizotinib (n=18) Alectinib (n=21) Median PFS, months (95%CI) 12.7 (9.2, 14.9) NR 7.4 (2.7, NR) 3.8 (1.9, NR) HR (95%CI) p-value 0.40 (0.27, 0.61) p< (0.59, 3.53) p=0.41 Responders, % (95%CI) 81 (72, 89) 91 (83, 95) 44 (22, 69) 29 (11, 52) FISH-unknown status was assigned to 36 crizotinib- and 25 alectinib-treated patients, 75% and 96%, respectively, were responders Conclusions Survival and response for patients with ALK IHC-positive/FISH-positive NSCLC was consistent with the primary analysis result Most patients with ALK IHC-positive/FISH-negative still derive clinical benefit from ALK inhibitors but to a lesser extent, this should be interpreted with caution due to low patient numbers Clinical benefit in the ALK IHC-positive/FISH-unknown group was similar to the ITT population Mok TSK et al. J Thorac Oncol 2017;12(suppl):Abstr MA 07.01

41 MA 10.01: Durvalumab ± Tremelimumab with Platinum-Doublets in Non-Small Cell Lung Cancer: Canadian Cancer Trials Group Study IND.226 Juergens RA, et al Study objective To confirm the RP2D, and assess the safety, tolerability and anti-tumour activity of durvalumab ± tremelimumab in combination with platinum-doublet chemotherapy in patients with NSCLC Non-squamous tumours Key patient inclusion criteria Metastatic NSCLC No prior therapy for advanced disease (n=54) R Durvalumab ± tremelimumab + pemetrexed + cisplatin/carboplatin then maintenance pemetrexed (n=45) Squamous tumours Durvalumab ± tremelimumab + gemcitabine + cisplatin/carboplatin (n=9) PD/ death/ toxicity PD/ death/ toxicity Primary endpoint RP2D Secondary endpoints Anti-tumour activity, safety Juergens RA et al. J Thorac Oncol 2017;12(suppl):Abstr MA 10.01

42 Best % tumour shrinkage from baseline Best % tumour shrinkage from baseline MA 10.01: Durvalumab ± Tremelimumab with Platinum-Doublets in Non-Small Cell Lung Cancer: Canadian Cancer Trials Group Study IND.226 Juergens RA, et al Key results For grade 3 AEs, there was no clear dose response in the pemetrexedplatinum or gemcitabine-platinum cohorts An increase in grade 3 iraes may be seen when adding tremelimumab Conclusion Pem-platinum cohorts (n=33) Cohort 1: Pemetrexed and cisplatin Cohort 5: Pemetrexed and carboplatin Gem-platinum cohorts (n=6) In patients with metastatic NSCLC, the combination of durvalumab ± tremelimumab can be administered with platinum-doublet chemotherapy with an expected range of AEs and with encouraging preliminary response data Cohort 3: Gemcitabine and cisplatin Cohort 7: Gemcitabine and carboplatin Juergens RA et al. J Thorac Oncol 2017;12(suppl):Abstr MA 10.01

43 OA 17.02: Updated Efficacy Results From the BIRCH Study: First-Line Atezolizumab Therapy in PD-L1 Selected Patients With Advanced NSCLC Carcereny E, et al Study objective To assess the updated survival data for 1L atezolizumab in PD-L1+ patients with advanced NSCLC in the chemotherapy-naïve cohort of the BIRCH trial Key patient inclusion criteria Locally advanced or metastatic NSCLC Tumour PD-L1 expression by IHC (TC2/3 or IC2/3) No brain metastases ECOG PS 0 1 Chemotherapy-naïve cohort: Atezolizumab 1200 mg q3w (n=138) PD Primary endpoint Independent review facility-assessed ORR Secondary endpoints Investigator-assessed ORR, DoR, PFS, OS, safety Carcereny E et al. J Thorac Oncol 2017;12(suppl):Abstr OA 17.02

44 Frequency, % OA 17.02: Updated Efficacy Results From the BIRCH Study: First-Line Atezolizumab Therapy in PD-L1 Selected Patients With Advanced NSCLC Carcereny E, et al Key results Response rates TC2/3 or IC2/3 TC3 or IC3 TC2 or IC % 41% 35% 32% 18% 49% 0 CR/PR Response was observed in patients with either EGFR or KRAS wild-type (ORR 31% for both) or mutated tumours (EGFR 23%; KRAS 24%) 2-year OS rates were 50% (95%CI 41.5, 59.2) in TC2/3 or IC2/3 group, 52% (95%CI 39.3, 65.2) in the TC3 or IC3 group and 49% (95%CI 37.0, 61.1) in the TC2 or IC2 group Conclusion 1L treatment of NSCLC with atezolizumab continued to demonstrate durable activity beyond 2 years Carcereny E et al. J Thorac Oncol 2017;12(suppl):Abstr OA SD

45 OA 17.06: Updated Analysis of KEYNOTE-024: Pembrolizumab vs Platinum- Based Chemotherapy for Advanced NSCLC With PD-L1 TPS 50% Brahmer JR, et al Study objective To compare the efficacy and safety of 1L pembrolizumab with platinum-based chemotherapy for patients with advanced NSCLC Key patient inclusion criteria Untreated stage IV NSCLC PD-L1 tumour proportion score 50% No activating EGFR mutations or ALK translocations ECOG PS 0 1 (n=305) Primary endpoint PFS R 1:1 Pembrolizumab 200 mg IV q3w (2 years) (n=154) Stratification ECOG PS (0 vs. 1) Histology (squamous vs. non-squamous) Region (East Asia vs. non East Asia) Platinum-based chemotherapy 4 6 cycles (investigator's choice) (n=151) PD Secondary endpoints OS, ORR, DoR, safety Pembrolizumab 200 mg IV q3w (2 years) (n=82) Brahmer JR et al. J Thorac Oncol 2017;12(suppl):Abstr OA 17.06

46 Overall survival, % OA 17.06: Updated Analysis of KEYNOTE-024: Pembrolizumab vs Platinum- Based Chemotherapy for Advanced NSCLC With PD-L1 TPS 50% Brahmer JR, et al Key results Pembrolizumab Chemotherapy 70.3% 54.8% Updated OS 51.5% 34.5% Events, n HR (95%CI) Pembrolizumab (0.47, 0.86) Chemotherapy 96 p=0.002 Median (95%CI) 30.0 mo (18.3, NR) 14.2 mo (9.8, 19.0) No. at risk Pembro Chemo Conclusion Time, months Pembrolizumab continues to show an OS benefit as 1L therapy compared with platinum-based chemotherapy for advanced NSCLC with PD-L1 TPS 50% Brahmer JR et al. J Thorac Oncol 2017;12(suppl):Abstr OA

47 Advanced NSCLC Not radically treatable stage III and stage IV Later lines

48 MA 02.02: Phase 2 Study of Pembrolizumab Plus CC-486 vs Pembrolizumab Plus Placebo in Previously Treated Patients with Advanced NSCLC Levy BP, et al Study objective To investigate the addition of CC-486, an oral formulation of azacitidine, to 2L pembrolizumab in patients with advanced or metastatic NSCLC Key patient inclusion criteria Stage IIIB/IV NSCLC CC mg D pembrolizumab 200 mg D1 (n=51) PD ALK/EGFR wild type 1 prior platinum-based chemotherapy (n=100) R 1:1 Stratification Histology Placebo D pembrolizumab 200 mg D1 (n=49) PD Primary endpoint PFS Secondary endpoints Safety, OS, ORR, DCR Levy BP et al. J Thorac Oncol 2017;12(suppl):Abstr MA 02.02

49 Progression-free survival MA 02.02: Phase 2 Study of Pembrolizumab Plus CC-486 vs Pembrolizumab Plus Placebo in Previously Treated Patients with Advanced NSCLC Levy BP, et al Key results 1.0 Median, months HR (90%CI) p-value CC pembro Placebo + pembro 4.0 (0.904, 2.035) No. at risk 0.0 CC pembro Placebo + pembro High PD-L1 expression was not predictive of CC-486 efficacy Conclusion Months CC pembrolizumab did not improve PFS in patients with advanced NSCLC compared with placebo + pembrolizumab Levy BP et al. J Thorac Oncol 2017;12(suppl):Abstr MA 02.02

50 MA 02.05: Nivolumab in Advanced Non-Squamous NSCLC Patients with KRAS Mutations: Results from the Italian Expanded Access Program (EAP) Ardizzoni A, et al Study objective To investigate the efficacy of nivolumab in patients with advanced nonsquamous NSCLC with KRAS mutations from an expanded access programme Key patient inclusion criteria Stage IIIB/IV non-squamous NSCLC 1 prior systemic treatment KRAS mutation-positive (n=206) Nivolumab 3 mg/kg IV q2w for up to 24 months PD Endpoints ORR, DCR, PFS, OS Ardizzoni A et al. J Thorac Oncol 2017;12(suppl):Abstr MA 02.05

51 MA 02.05: Nivolumab in Advanced Non-Squamous NSCLC Patients with KRAS Mutations: Results from the Italian Expanded Access Program (EAP) Ardizzoni A, et al Key results Response rates with nivolumab were similar in the KRAS mutation-positive subgroup to the whole patient population Response, n (%) KRAS mutation-positive (n=206) All patients (n=1588) ORR 41 (20) 290 (18) DCR 96 (47) 704 (44) Median OS was 11.2 (95%CI 9.3, 13.1) vs months (95%CI 10.2, 12.4) for KRAS mutation-positive vs. whole patient population, respectively Grade 3/4 TRAEs occurred in 11% of patients with KRAS mutations compared with 6% of the whole population Conclusion Efficacy and safety of nivolumab in patients with KRAS mutation-positive NSCLC is similar to that observed in the overall population and CheckMate 057 Ardizzoni A et al. J Thorac Oncol 2017;12(suppl):Abstr MA 02.05

52 OA 05.05: Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Updated Efficacy and Safety Results From ALTA, a Randomized Phase 2 Trial Ahn M-J, et al Study objective To assess the efficacy and safety of two treatment regimens with brigatinib, a next-generation ALK inhibitor, in patients with crizotinib-refractory, advanced ALK+ NSCLC Key patient inclusion criteria Locally advanced or metastatic ALK+ NSCLC Disease progression on crizotinib No other ALK-directed therapy (n=222) R 1:1 Brigatinib 90 mg/day (n=112) Stratification Brain metastases at baseline Best response to prior crizotinib Brigatinib 180 mg/day with 7-day lead in at 90 mg/day (n=110) PD/ toxicity PD/ toxicity Primary endpoint ORR (investigator assessed) Secondary endpoints ORR (assessed by IRC), CNS response, DoR, PFS, OS, safety Ahn M-J et al. J Thorac Oncol 2017;12(suppl):Abstr OA 05.05

53 Probability of PFS, % OA 05.05: Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Updated Efficacy and Safety Results From ALTA, a Randomized Phase 2 Trial Ahn M-J, et al Key results ORR was 55% (range 44 66) with 180 mg/day compared with 46% (range 35 57) with 90 mg/day Investigator-assessed PFS Brigatinib 90 mg/day (% events = 65) Brigatinib 180 mg/day (% events = 50) Median PFS, months (95%CI) 9.2 (7.4, 11.1) 15.6 (11.1, 19.4) HR (95%CI) 0.64 (0.45, 0.91) Brigatinib 90 mg/day (n=112) Brigatinib 180 mg/day (n=110) Time, months Conclusion In this updated analysis, brigatinib continues to demonstrate good response and an acceptable safety profile at both doses Ahn M-J et al. J Thorac Oncol 2017; 12 (suppl): abstr OA 05.05

54 OA 05.07: Efficacy and Updated Safety of Ceritinib (450 mg or 600 mg) with Low-Fat Meal vs 750 mg Fasted in ALK+ Metastatic NSCLC Cho B, et al Study objective To assess the efficacy and safety of three different regimens of ceritinib in patients with ALK+ metastatic NSCLC Key patient inclusion criteria Stage IIIB/IV ALK+ advanced NSCLC Previously treated with chemotherapy and/or crizotinib or treatment naïve WHO PS 0 2 (n=267) R 1:1:1 Stratification Brain metastases Prior treatment Ceritinib 450 mg/day with low-fat meal (n=89) Ceritinib 600 mg/day with low-fat meal (n=87) Ceritinib 750 mg/day in fasted state (n=91) PD/toxicity/ withdrawal PD/toxicity/ withdrawal PD/toxicity/ withdrawal Primary endpoint ORR and DoR in treatment naïve Secondary endpoints ORR, DoR, TTR, DCR, PFS, OS, safety Cho B et al. J Thorac Oncol 2017;12(suppl):Abstr OA 05.07

55 OA 05.07: Efficacy and Updated Safety of Ceritinib (450 mg or 600 mg) with Low-Fat Meal vs 750 mg Fasted in ALK+ Metastatic NSCLC Cho B, et al Key results Responses in treatment naïve ORR, n (%) [95%CI] CR PR SD PD Unknown Ceritinib 450 mg fed (n=41) 32 (78.0) [62.4, 89.4] 1 (2.4) 31 (75.6) 6 (14.6) 2 (4.9) 1 (2.4) Ceritinib 600 mg fed (n=40) 30 (75.0) [58.8, 87.3] 0 30 (75.0) 7 (17.5) 2 (5.0) 1 (2.5) Ceritinib 750 mg fasted (n=40) 28 (70.0) [53.5, 83.4] 1 (2.5) 27 (67.5) 8 (20.0) 1 (2.5) 3 (7.5) DCR, n (%) [95%CI] 38 (92.7) [80.1, 98.5] 37 (92.5) [79.6, 98.4] 36 (90.0) [76.3, 97.2] Median TTR, weeks (95%CI) 6.3 (6.0, 6.9) 6.3 (6.1, 12.1) 6.3 (6.0, 12.3) Median PFS was 17.6 months (95%CI 8.5, NE) with 450 mg dose, NE (95%CI 8.3, NE) at 600 mg dose and 10.9 months (95%CI 6.3, NE) at 750 mg At the 450 mg dose ceritinib offered the highest exposure and fewest dose reductions (median treatment exposure of 37.9 weeks compared with 35.3 weeks at 600 mg and 33.1 weeks at 750 mg) Cho B et al. J Thorac Oncol 2017;12(suppl):Abstr OA 05.07

56 OA 05.07: Efficacy and Updated Safety of Ceritinib (450 mg or 600 mg) with Low-Fat Meal vs 750 mg Fasted in ALK+ Metastatic NSCLC Cho B, et al Key results (cont.) Based on all treated patients (n=265), the overall AE profile was similar among the three treatment arms except for a lower proportion of GI toxicities in the 450 mg fed arm Ceritinib 450 mg fed (n=89) Ceritinib 600 mg fed (n=86) Ceritinib 750 mg fasted (n=90) GI AEs leading to study drug discontinuation, n (%) Nausea Vomiting Diarrhoea (1.2) 1 (1.2) GI AEs requiring dose adjustments, n (%) Nausea Diarrhoea Vomiting (7.0) 6 (7.0) 3 (3.5) 4 (4.4) 6 (6.7) 4 (4.4) GI AE requiring dose adjustment/study drug interruption, n (%) Diarrhoea Nausea Vomiting 6 (6.7) 1 (1.1) 0 9 (10.5) 11 (12.8) 10 (11.6) 16 (17.8) 11 (12.2) 10 (11.1) Conclusion Ceritinib 450 mg administered with food might offer similar efficacy to 750 mg fasted dose with better GI toxicity Cho B et al. J Thorac Oncol 2017;12(suppl):Abstr OA 05.07

57 MA 10.03: 3-Year Survival and Duration of Response in Randomized Phase II Study of Atezolizumab vs Docetaxel in 2L/3L NSCLC (POPLAR) Park K, et al Study objective To report 3-year survival data from the POPLAR study of atezolizumab vs. docetaxel in patients with advanced NSCLC Methods Patients with metastatic or locally advanced NSCLC (2L/3L) (n=287) were randomised 1:1 to atezolizumab (1200 mg q3w) or docetaxel (75 mg/m 2 q3w) Data cut-off, April 7, 2017; minimum follow-up, 3 years Key results 3-year OS was 19% with atezolizumab vs. 10% with docetaxel ORR was 15% with both atezolizumab and docetaxel Conclusions At all landmark time points, OS was superior with atezolizumab vs. docetaxel Improved 3-year OS with atezolizumab is observed across histology and PD-L1 expression subgroups Park K et al. J Thorac Oncol 2017;12(suppl):Abstr MA 10.03

58 MA 10.11: Hyperprogressive Disease (HPD) Is Frequent in Non-Small Cell Lung Cancer (NSCLC) Patients (Pts) Treated with Anti PD1/PD-L1 Agents (IO) Ferrara R, et al Study objective To explore the rate and prognostic value of hyperprogressive disease (HPD) in a large cohort of patients with advanced NSCLC treated with anti-pd-1/pd-l1 agents or chemotherapy Methods Multicentre retrospective analysis of patients with advanced NSCLC treated with anti-pd-1/pd-l1 agents (n=406) or single agent chemotherapy (n=59) Tumour growth rate (TGR) was calculated before and during treatment HPD was defined as a 2-fold increase in TGR vs. before treatment and PD at first CT scan during treatment Ferrara R et al. J Thorac Oncol 2017;12(suppl):Abstr MA 10.11

59 MA 10.11: Hyperprogressive Disease (HPD) Is Frequent in Non-Small Cell Lung Cancer (NSCLC) Patients (Pts) Treated with Anti PD1/PD-L1 Agents (IO) Ferrara R, et al Key results Anti-PD-1/PD-L1 cohort: CR/PR 19%, SD 39%, PD 42%, HPD 14% Chemotherapy cohort: CR/PR 10%, SD 31%, PD 59%, HPD 5% Anti-PD-1/PD-L1 cohort Non-HPD (n=350) HPD (n=56) HR (95%CI) p-value No. met sites at baseline, n (%) (57) 21 (38) >2 149 (53) 35 (63) - - OS, months (95%CI) PD patients 5.8 (4.9, 6.8) 3.4 (2.3, 5.8) 1.55 (1.07, 2.25) 0.01 OS in chemotherapy cohort: 3.9 for PD non-hpd vs. 4.5 months for HPD Conclusions In patients with advanced NSCLC, HPD correlated with a higher number of metastatic sites prior to anti-pd-1/pd-l1 treatment In patients on anti-pd-1/pd-l1 therapy, HPD correlated with poor survival Ferrara R et al. J Thorac Oncol 2017;12(suppl):Abstr MA 10.11

60 OA 09.03: TATTON Ph Ib Expansion Cohort: Osimertinib plus Savolitinib for Pts with EGFR-Mutant MET-Amplified NSCLC after Progression on Prior EGFR-TKI Ahn M-J, et al Study objective To investigate the safety and preliminary activity of osimertinib + savolitinib in patients with EGFR-mutant NSCLC and MET-positive acquired resistance Key patient inclusion criteria Advanced NSCLC EGFR mutation-positive MET-positive status Progressed on 1 prior EGFR- TKI WHO PS 0 1 (n=66) Received prior 3rd gen T790M-directed EGFR-TKI (n=30) T790M+ with no prior 3rd gen T790M-directed EGFR-TKI (n=12) T790M- with no prior 3rd gen T790M-directed EGFR-TKI (n=24) Osimertinib 80 mg/day + savolitinib 600 mg/day Primary endpoint Safety and tolerability Secondary endpoints ORR, DoR, change in tumour size, PK Ahn M-J et al. J Thorac Oncol 2017;12(suppl):Abstr OA 09.03

61 OA 09.03: TATTON Ph Ib Expansion Cohort: Osimertinib plus Savolitinib for Pts with EGFR-Mutant MET-Amplified NSCLC after Progression on Prior EGFR-TKI Ahn M-J, et al Key results AEs of any grade and causality occurred in 92% of patients, with nausea (44%) and vomiting (35%) the most common Grade 3 AEs were reported in 50% of patients Preliminary anti-tumour activity was promising across all groups among patients with centrally confirmed MET-positive status Response, n (%) Prior 3rd gen T790M-directed EGFR-TKI (n=25) No prior 3rd gen T790M-directed EGFR-TKI T790M+ (n=7) T790M- (n=15) Total (n=47) CR PR 7 (28) 4 (57) 8 (53) 19 (40) SD 6 weeks 13 (52) 3 (43) 6 (40) 22 (47) Conclusions This phase 1b expansion cohort showed a safety profile consistent with the first phase of this study Osimertinib + savolitinib showed anti-tumour activity in all the MET-positive groups, regardless of EGFR T790M mutation status or prior T790M-directed EGFR-TKI therapy Ahn M-J et al. J Thorac Oncol 2017;12(suppl):Abstr OA 09.03

62 OA 17.07: Long-Term Survival in Atezolizumab-Treated Patients with 2L+ NSCLC from Ph III Randomized OAK Study Satouchi M, et al Study objective To evaluate the characteristics of long-term survivors (LTS) with NSCLC receiving cancer immunotherapy in the OAK study Methods Phase 3 randomised controlled trial of atezolizumab 1200 mg q3w vs. docetaxel 75 mg/m 2 in patients with locally advanced or metastatic NSCLC who had received 1 2 prior lines of chemotherapy (at least 1 platinum-based) LTS were patients who lived 24 months from randomisation Key results 2-year OS was 31% with atezolizumab vs. 21% with docetaxel Atezolizumab LTS were not limited to radiographic responders; 21% atezolizumab vs. 9% docetaxel LTS had PD as best overall response Conclusions Long-term survival of patients with NSCLC is better with atezolizumab than docetaxel This benefit was consistent across histologies (squamous/non-squamous) and PD-L1 expression Satouchi M et al. J Thorac Oncol 2017;12(suppl):Abstr OA 17.07

63 OA 17.08: Phase II Study of Pembrolizumab for Oligometastatic Non-Small Cell Lung Cancer (NSCLC) Following Completion of Locally Ablative Therapy (LAT) Bauml JM, et al Study objective To investigate the efficacy and safety of pembrolizumab after local ablative therapy (LAT) in patients with oligometastatic NSCLC Key patient inclusion criteria NSCLC 4 metastases (any site) No limit on prior therapies except no PD-1/PD-L1 inhibitors PS 0 1 (n=45) Definitive treatment to all known sites of disease Pembrolizumab 200 mg q3w for 6 months SD or better PD or patient preference Pembrolizumab 200 mg q3w for 6 months Discontinued Primary endpoints PFS, safety Secondary endpoints QoL, OS Baumi JM et al. J Thorac Oncol 2017;12(suppl):Abstr OA 17.08

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