Lung Cancer Immunotherapy
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1 Lung Cancer Immunotherapy Luis E. Raez MD FACP FCCP Chief of Hematology/Oncology & Medical Director Memorial Cancer Institute/Memorial Health Care System Clinical Professor of Medicine Herbert Wertheim College of Medicine Florida International University
2 Research Support: BMS Genentech/Roche Pfizer Biodesix MSD Merck Serono Lilly Oncology Boheringer Ingelheim Novartis Astra-Zeneca Liquid Genomics Speakers Bureau/Stocks: None
3 Origins of cancer immunology
4 T cell inflamed vs. non-inflamed tumors and responses to checkpoint inhibitors 4
5 Working model: immunobiology of T cell-inflamed and non-inflamed tumor microenvironment Presented By Thomas Gajewski at 2017 ASCO Annual Meeting
6 Slide 2 Presented By Solange Peters at 2018 ASCO Annual Meeting
7 Checkpoint Blockade Anti-CTLA-4 Anti-PD-L1 Anti-PD-1 Ipilimumab (Fully human IgG1) FDA approved 2011 Tremelimumab (Fully human IgG2) Phase III MDX-1105 (Fully human IgG4) Phase I MPDL3280A, RG7446, Atezolizumab Phase II-III FDA approved 2016 NSCLC MEDI4736, Durvalumab; Phase III MDX-1106, Nivolumab (Fully human IgG4) FDA approved for melanoma, NSCLC, urothelial carcinoma, RCC, HL, SCCHN CT-011 Pidilizumab (Humanized IgG1) Phase II MK3475 Pembrolizumab (formerly Lambrolizumab) (Humanized IgG4) FDA approved for melanoma, NSCLC, SCCHN MSB C, Avelumab Phase I-II AMP-224 (B7-DC/IgG1fusion protein) Phase I-II MEDI0680, AMP514 Phase I
8 NSCLC Second line Immunotherapy Nivolumab [Checkmate 057 and 017] Pembrolizumab [Keynote 010] Atezolizumab [Oak] 8
9 Slide 19
10 NSCLC First line Immunotherapy Pembrolizumab [Keynote 024] 10
11 Kaplan-Meier Estimate of OS: <br />Updated Analysis
12 Combining Immunotherapy 1) Chemotherapy: (NSQCC) Carboplatin/Pemetrexed/Pembrolizumab [Keynote 021 (9/2017) and Keynote 189 (1/2018)] 2) Immunotherapy (NSQCC and SQCC) Ipilimumab and nivolumab [Checkmate 227 (2/2018)] 12
13 KEYNOTE 189 Co-primary endpoints: mpfs and mos Presented By Melissa Johnson at 2018 ASCO Annual Meeting
14 KEYNOTE 189: OS by PDL1 Expression Presented By Melissa Johnson at 2018 ASCO Annual Meeting
15 Slide 29
16 Slide 8
17 ASCO 2018 Keynote 042: First Line (NSQCC) Carbo/Pem vs Pembro [PD-L1 >1%] IMPOWER 150: First Line (NSQCC) Carbo/Paclit/Bev/Atezo vs SOC IMPOWER 131: First Line (SQCC) Carbo/Nab-Pac/Atezo vs SOC KEYNOTE 407: First Line (SQCC) Carbo/Paclit or Nab/Pembro vs SOC 17
18 Pembrolizumab vs Platinum-Based Chemotherapy as First-Line Therapy for Advanced/Metastatic NSCLC With a PD-L1 TPS 1%: Open-Label, Phase 3 KEYNOTE-042 Study Presented By Gilberto Lopes at 2018 ASCO Annual Meeting
19 KEYNOTE-042 Study Design Presented By Gilberto Lopes at 2018 ASCO Annual Meeting
20 Overall Survival: TPS 50% Presented By Gilberto Lopes at 2018 ASCO Annual Meeting
21 Overall Survival: TPS 1% Presented By Gilberto Lopes at 2018 ASCO Annual Meeting
22 Overall Survival: TPS 1-49% (Exploratory Analysisa) Presented By Gilberto Lopes at 2018 ASCO Annual Meeting
23 Progression-Free Survival: TPS 50%<br />(RECIST v1.1, BICR) Presented By Gilberto Lopes at 2018 ASCO Annual Meeting
24 Progression-Free Survival: TPS 1%<br />(RECIST v1.1, BICR) Presented By Gilberto Lopes at 2018 ASCO Annual Meeting
25 Response Rate by TPS <br />(RECIST v1.1, BICR) Presented By Gilberto Lopes at 2018 ASCO Annual Meeting
26 Summary and Conclusions Presented By Gilberto Lopes at 2018 ASCO Annual Meeting
27 IMpower150: Overall Survival Analysis of a Randomized Phase III Study of Atezolizumab + Chemotherapy ± Bevacizumab vs Chemotherapy + Bevacizumab in 1L Nonsquamous NSCLC Presented By Mark Socinski at 2018 ASCO Annual Meeting
28 IMpower150 Study Design Presented By Mark Socinski at 2018 ASCO Annual Meeting
29 Updated PFS Analysis in the ITT-WT (Arm B vs Arm C) Presented By Mark Socinski at 2018 ASCO Annual Meeting
30 OS in the ITT-WT (Arm B vs Arm C) Presented By Mark Socinski at 2018 ASCO Annual Meeting
31 OS in the ITT-WT (Arm A vs Arm C) Presented By Mark Socinski at 2018 ASCO Annual Meeting
32 Addition of Bevacizumab to Atezolizumab and Chemotherapy Prolongs Survival of Patients With Liver Metastases in the ITT-WT Presented By Mark Socinski at 2018 ASCO Annual Meeting
33 Addition of Bevacizumab to Atezolizumab and Chemotherapy Prolongs Survival of EGFR/ALK+ Patientsa Presented By Mark Socinski at 2018 ASCO Annual Meeting
34 OS in the ITT (Arm B vs Arm C) Presented By Mark Socinski at 2018 ASCO Annual Meeting
35 Summary Presented By Mark Socinski at 2018 ASCO Annual Meeting
36 Slide 17 Presented By Melissa Johnson at 2018 ASCO Annual Meeting
37 When might we still consider chemotherapy + IO? Presented By Melissa Johnson at 2018 ASCO Annual Meeting
38 IMpower131: Primary PFS and Safety Analysis of a Randomized Phase III Study of Atezolizumab + Carboplatin + Paclitaxel or Nab-Paclitaxel vs Carboplatin + Nab-Paclitaxel as 1L Therapy in Advanced Squamous NSCLC Presented By Robert Jotte at 2018 ASCO Annual Meeting
39 IMpower131: Study Design Presented By Robert Jotte at 2018 ASCO Annual Meeting
40 INV-Assessed PFS in the ITT Population (Arm B vs Arm C) Presented By Robert Jotte at 2018 ASCO Annual Meeting
41 First Interim OS in the ITT Population (Arm B vs Arm C) Presented By Robert Jotte at 2018 ASCO Annual Meeting
42 Summary Presented By Robert Jotte at 2018 ASCO Annual Meeting
43 KEYNOTE-407: Phase 3 Study of Carboplatin-Paclitaxel/Nab-Paclitaxel With or Without Pembrolizumab for Metastatic Squamous NSCLC Presented By Luis Paz-Ares at 2018 ASCO Annual Meeting
44 KEYNOTE-407 Study Design (NCT ) Presented By Luis Paz-Ares at 2018 ASCO Annual Meeting
45 Overall Survival at IA2, ITT Presented By Luis Paz-Ares at 2018 ASCO Annual Meeting
46 Overall Survival at IA2 by PD-L1 TPS Presented By Luis Paz-Ares at 2018 ASCO Annual Meeting
47 Progression-Free Survival at IA2, ITT<br />(RECIST v1.1, BICR) Presented By Luis Paz-Ares at 2018 ASCO Annual Meeting
48 Summary and Conclusions Presented By Luis Paz-Ares at 2018 ASCO Annual Meeting
49 Conclusions ASCO 2018 KEYNOTE 042: Carbo/Pem vs Pembro [PD-L1 >1%]. Better OS except group PDL-1: 1-49% IMPOWER 150: Carbo/Paclit/Bev/Atezo vs SOC. Better OS across all levels of PD-L1 IMPOWER 131: (SQCC) Carbo/Nab-Pac/Atezo vs SOC Better PFS, potential new SOC KEYNOTE 407: (SQCC) Carbo/Paclit or Nab/Pembro vs SOC Better OS all PD-L1 groups (NEW SOC) Adds to KEYNOTE 189: Carbo/Pem/Pem for NSQCC and Checkmate 227: Ipi+Nivo better PFS for all in pts high TMB 49
50 Slide 32 Presented By Solange Peters at 2018 ASCO Annual Meeting
51
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