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8/19/2018 Lung Cancer Updates 2018 Edward S. Kim, M.D., FACP Chair, Solid Tumor Oncology and Investigational Therapeutics Donald S. Kim Distinguished Chair for Cancer Research Medical Director, Clinical Trials Office Levine Cancer Institute

  1. 8/19/2018 Lung Cancer Updates 2018 Edward S. Kim, M.D., FACP Chair, Solid Tumor Oncology and Investigational Therapeutics Donald S. Kim Distinguished Chair for Cancer Research Medical Director, Clinical Trials Office Levine Cancer Institute Charlotte, NC 1

  2. 8/19/2018 Organizations L E V I N E C A N C E R I N S T I T U T E 2

  3. 8/19/2018 NSCLC: A Major Public Health Problem • Estimated 1.6 million deaths each year worldwide from lung cancer • In 2015: • Estimated 221,200 new cases of lung cancer expected to be diagnosed in US • 158,000 Americans expected to die from lung cancer • Leading cause of cancer-related deaths in US men and women • More deaths from lung cancer than breast, prostate, colon, liver, melanoma, and kidney cancers combined • Need for better thought out, patient-driven studies Torre LA, et al. CA Cancer J Clin. 2015;65(2):87-108. Siegel RL, et al. CA Cancer J Clin. 2015;65(1):5-29. L E V I N E C A N C E R I N S T I T U T E 3

  4. 8/19/2018 Importance of Clinical Trials L E V I N E C A N C E R I N S T I T U T E 4

  5. 8/19/2018 Must Allow More Patients to Participate L E V I N E C A N C E R I N S T I T U T E 5

  6. 8/19/2018 L E V I N E C A N C E R I N S T I T U T E 6

  7. 8/19/2018 L E V I N E C A N C E R I N S T I T U T E 7

  8. 8/19/2018 Lung Cancer Treatment 2000: ECOG 1594 Comparison of 4 First-Line Doublet Regimens in Advanced NSCLC • Nonsquamous and squamous histologies • No differences • Probability of Survival Efficacy not so encouraging • Easy for providers to “take home a message” • “Treat with any doublet you would like” Schiller JH, et al. N Engl J Med . 2002;346:92-98. L E V I N E C A N C E R I N S T I T U T E 8

  9. 8/19/2018 E4599: Bevacizumab with Chemotherapy in NSCLC Overall Survival Median survival: 12.5 vs 10.2 months 100 HR = 0.77 (95% CI: .65, .93), P = 0.007 1-yr Survival: 52% vs 44% 80 2-yr Survival: 22% vs 17% Patients surviving, % 60 Treatment group Carboplatin and paclitaxel 40 Carboplatin and paclitaxel + bevacizumab 20 0 0 6 12 18 24 30 36 Months L E V I N E C A N C E R I N S T I T U T E Sandler et al. NEJM 2006 9

  10. 8/19/2018 NSCLC Drug Approvals/Indications: 2015 - Present • Alectinib • Pembrolizumab – PD-L1 + (1 st , 2 nd line) • Necitumumab • Nivolumab – MSI-H or dMMR solid tumors • Osimertinib – NSCLC (Carboplatin • Gefitinib + Pemetrexed) • Ramucirumab • Crizotinib (ROS1) • Atezolizumab • Dabrafenib, Trametinib • Ceritinib • Durvalumab • Brigatinib L E V I N E C A N C E R I N S T I T U T E 10

  11. 8/19/2018 The Changing Landscape of Lung Cancer: 2005 80 of 100 patients eligible for chemotherapy Only 15-20% of tumors had a partial response 8/19/2018 11 11

  12. 8/19/2018 The Changing Landscape of Lung Cancer: 2018 Molecular subsets: EGFR Mutations 8/19/2018 12 12

  13. 8/19/2018 The Changing Landscape of Lung Cancer: 2018 Molecular subsets: ALK 8/19/2018 13 13

  14. 8/19/2018 The Changing Landscape of Lung Cancer: 2018 Molecular subsets: ROS1 8/19/2018 14 14

  15. 8/19/2018 The Changing Landscape of Lung Cancer: 2018 Molecular subsets: PD-L1 8/19/2018 15 15

  16. 8/19/2018 The Changing Landscape of Lung Cancer: 2018 Molecular subsets: BRAFv600E 8/19/2018 16 16

  17. 8/19/2018 The Changing Landscape of Lung Cancer: 2018 Molecular subsets: 50% of patients candidates for targeted therapy 8/19/2018 17 17

  18. 8/19/2018 L E V I N E C A N C E R I N S T I T U T E 18

  19. 8/19/2018 Screening for Lung Cancer L E V I N E C A N C E R I N S T I T U T E 19

  20. 8/19/2018 L E V I N E C A N C E R I N S T I T U T E 20

  21. 8/19/2018 Precision Medicine Works Precision Medicine Works L E V I N E C A N C E R I N S T I T U T E 21

  22. 8/19/2018 Biomarker Recommendations: Practical Applications • EGFR • BRAF • ALK • ROS1 • PD-L1 • EGFR T790M L E V I N E C A N C E R I N S T I T U T E 22

  23. 8/19/2018 Treatment Algorithm NSCLC 2018 • EGFR Targeted therapy • ALK • Osimertinib • Alectinib • BRAF V600E • Dabrafenib/Trametinib • ROS-1 • Crizotinib Non-squamous • C-MET exon 14 • Other TKIs • RET Carboplatin Pemetrexed Pt w/treatment PD-L1< 50% Pembrolizumab naïve metastatic PD- L1 ≥ 50% NSCLC Pembrolizumab TMB High Nivolumab/Ipilimumab No targetable Platinum-based mutations chemotherapy Squamous Carboplatin PD-L1< 50% nab-paclitaxel Pembrolizumab L E V I N E C A N C E R I N S T I T U T E 23

  24. 8/19/2018 KEYNOTE-042 Study Design: Pembrolizumab vs. chemotherapy L E V I N E C A N C E R I N S T I T U T E 24

  25. 8/19/2018 KEYNOTE-042 Lopes, ASCO 2018 L E V I N E C A N C E R I N S T I T U T E 25

  26. 8/19/2018 KEYNOTE-042 Lopes, ASCO 2018 L E V I N E C A N C E R I N S T I T U T E 26

  27. 8/19/2018 KEYNOTE-042 L E V I N E C A N C E R I N S T I T U T E 27

  28. 8/19/2018 KEYNOTE-042 L E V I N E C A N C E R I N S T I T U T E 28

  29. 8/19/2018 Implications of KEYNOTE-042 • Single agent Pembrolizumab has activity in PD-L1 + lung cancer • PD- L1 ≥ 50% continue single agent • Consider the response rates • Fit patients should be considered for combination chemotherapy (KEYNOTE-189) • Medically less fit patients should be given single agent L E V I N E C A N C E R I N S T I T U T E 29

  30. 8/19/2018 L E V I N E C A N C E R I N S T I T U T E 30

  31. 8/19/2018 KEYNOTE-189 Study Design Key eligibility Pembrolizumab Endpoints (200 mg fixed dose criteria: Pembrolizumab q3w) plus pemetrexed Primary endpoints 200 mg plus (500 mg/m 2 ), with • ≥18 years old • PFS per RECIST v1.1 pemetrexed vitamin (500 mg/m 2 ) q3w until • OS • Histologically or supplementation, disease progression, cytologically confirmed plus cisplatin unacceptable toxicity, diagnosis of stage IV (75 mg/m 2 ) or Secondary endpoints physician decision, or nonsquamous NSCLC carboplatin AUC 5 on • ORR per RECIST consent withdrawal Day 1 q3w for 4 • No prior systemic therapy v1.1 cycles N=614 for advanced or • DoR metastatic disease R 2:1 • Number of Placebo plus • Measurable disease participants who pemetrexed Placebo plus (500 mg/m 2 ), with pemetrexed experience an AE • Can provide tumor tissue vitamin (500 mg/m 2 ) q3w until • Number of • ECOG PS 0 or 1 supplementation, plus disease progression, participants who cisplatin (75 mg/m 2 ) unacceptable toxicity, discontinue study • Any PD-L1 status or carboplatin AUC 5 physician decision, or treatment due to an • No EGFR and ALK on Day 1 q3w for 4 consent withdrawal AE cycles genomic tumor mutations 31 L E V I N E C A N C E R I N S T I T U T E 31

  32. 8/19/2018 KEYNOTE-189 Co-Primary Endpoint: PFS Events HR (95% CI) P Pembro/Pem/Plat 59.5% 0.52 (0.43-0.64) <0.001 100 Placebo/Pem/Plat 80.6% PFS in all key subgroups favored 90 34.1% Pembro/Pem/Plat 17.3% 80 • Age (<65, ≥65) 70 • Sex (male, female) 60 PFS, % • ECOG PS (0,1) Median (95% CI) 50 8.8 mo (7.6-9.2) • Smoking status 4.9 mo (4.7-5.5) 40 (current/former, never) • Baseline brain 30 metastases (yes, no) 20 • PD- L1 TPS (<1%, ≥1%, • PD- L1 TPS (<1%, ≥1%, 10 1- 49%, ≥50%) 1- 49%, ≥50%) 0 • Platinum chemotherapy 0 3 6 9 12 15 18 21 (carboplatin, cisplatin) Months No. at Risk 410 322 256 149 60 17 5 0 206 141 80 40 16 3 1 0 • a ITT, RECIST v1.1, BICR. Data cutoff date: Nov 8, 2017. • BICR, blinded independent central review; Pembro, pembrolizumab; pem, pemetrexed; plat, platinum chemotherapy; TPS, tumor proportion score. 32 • 1. Gandhi L, et al. N Engl J Med. 2018; 378(22):2078-2092. 2. Gandhi L, et al. Presented at: AACR 2018; April 14-18; Chicago, IL. Abstract CT075. L E V I N E C A N C E R I N S T I T U T E 32

  33. 8/19/2018 KEYNOTE-189 Co-Primary Endpoint: OS Events HR (95% CI) P Pembro/Pem/Plat 31.0% 0.49 (0.38-0.64) <0.001 100 Placebo/Pem/Plat 52.4% OS in all key subgroups favored 90 69.2% Pembro/Pem/Plat 49.4% 80 • Age (<65, ≥65) 70 • Sex (male, female) 60 OS, % • ECOG PS (0,1) Median (95% CI) 50 NR (NE-NE) • Smoking status 11.3 mo (8.7-15.1) 40 (current/former, never) 30 • Baseline brain metastases (yes, no) 20 • PD- L1 TPS (<1%, ≥1%, • PD- L1 TPS (<1%, ≥1%, 10 1- 49%, ≥50%) 1- 49%, ≥50%) 0 • Platinum chemotherapy 0 3 6 9 12 15 18 21 (carboplatin, cisplatin) Months No. at Risk 410 377 347 278 163 71 18 0 206 183 149 104 59 25 8 0 • Data cutoff date: Nov 8, 2017. • NE, not estimable; NR, not reported. 33 • 1. Gandhi L, et al. N Engl J Med . 2018; 378(22):2078-2092. 2. Gandhi L, et al. Presented at: AACR 2018; April 14- 18; Chicago, IL. Abstract CT075. L E V I N E C A N C E R I N S T I T U T E 33

  34. 8/19/2018 OS PFS 0% 0% 1-49% 1-49% >50% >50% L E V I N E C A N C E R I N S T I T U T E 34

  35. 8/19/2018 L E V I N E C A N C E R I N S T I T U T E 35

  36. 8/19/2018 L E V I N E C A N C E R I N S T I T U T E Paz-Ares, ASCO 2018 36

  37. 8/19/2018 KEYNOTE-407 L E V I N E C A N C E R I N S T I T U T E Paz-Ares, ASCO 2018 37

  38. 8/19/2018 Overall Survival at IA2, ITT L E V I N E C A N C E R I N S T I T U T E Presented By Luis Paz-Ares at 2018 ASCO Annual Meeting 38

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