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D. Cortinovis S.C. Oncologia Medica H S. Gerardo Monza

Camogli, 29 apr 2016. L’immunoterapia per pochi selezionati pazienti. D. Cortinovis S.C. Oncologia Medica H S. Gerardo Monza. AGENDA. LOOKING FOR A BIOMARKER CLUES IN THE CLINICAL SETTING BEYOND THE CLINICAL PERSPECTIVE. AGENDA. LOOKING FOR A BIOMARKER

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D. Cortinovis S.C. Oncologia Medica H S. Gerardo Monza

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  1. Camogli, 29 apr 2016 L’immunoterapia per pochi selezionati pazienti D. Cortinovis S.C. Oncologia Medica H S. Gerardo Monza

  2. AGENDA • LOOKING FOR A BIOMARKER • CLUES IN THE CLINICAL SETTING • BEYOND THE CLINICAL PERSPECTIVE

  3. AGENDA • LOOKING FOR A BIOMARKER • CLUES IN THE CLINICAL SETTING • BEYOND THE CLINICAL PERSPECTIVE

  4. VS Pennel vs Lisberg JAMA ONCOL 2016

  5. SELECTION IS AN ATTITUDE

  6. IS PDL1 A GOOD CANDIDATE? Garon NEJM 2015

  7. PEMBROLIZUMAB: KEYNOTE 010 Herbst Lancet 2015

  8. PEMBROLIZUMAB: PDL1>>EFFICACY PDL1> 1% PDL1> 50% Herbst Lancet 2015

  9. PDL1>> NO DISCORDANT mPFS PDL1> 50% PDL1> 1% Herbst Lancet 2015

  10. PDL1>> ACTIVITY

  11. PDL1 EXPRESSION AND ORR Garon NEJM 2015

  12. ATEZOLIZUMAB: POPLAR Fehrenbacher LANCET 2016

  13. EXHAUSTIVE SCORING SYSTEM: SAME RESULTS Fehrenbacher LANCET 2016

  14. DURVALUMAB EARLY TRIALS Rizvi ASCO 2015

  15. NIVOLUMAB + PDL1 STATUS: PREDICTIVE OR NOT… SCC NSQ Borghaei & Brahmer NEJM 2015

  16. PDL1 < 1% mOS mPFS ORR Abdel –RahmanCritrevOncolHematol 2016

  17. PDL1 > 1% mOS mPFS ORR Abdel –RahmanCritrevOncolHematol 2016

  18. WEIGHT OF SELECTION

  19. BEYOND PDL1 Fehrenbacher LANCET 2016

  20. MULTIFACTORIAL BIOMARKER InoueOncotarget 2016 TopalianNatCancerRev 2016

  21. AGENDA • LOOKING FOR A BIOMARKER • CLUES IN THE CLINICAL SETTING • BEYOND THE CLINICAL PERSPECTIVE

  22. Smoking status and response to immunotherapy in NSCLC In studies of nivolumab, a history of smoking in patients with NSCLC was associated with improved clinical response and PFS 100 PFS by smoking exposure 80 ≤5 pack-yrs smokers (mPFS 1.7 months) >5 pack-yrs smokers (mPFS 2.2 months)HR (95% CI) = 0.41 (0.22, 0.74), P = 0.003 60 40 PFS (%) 20 0 0 6 12 18 24 30 Months Since Treatment Initiation ≤5 pack-yrs smokers 14 3 1 1 1 1 >5 pack-yrs smokers 75 28 16 12 7 1 HR = hazard ratio; mPFS = median progression-free survival; ORR = objective response rate; PFS = progression-free survival. Hellmann MD, et al. Poster presented at ESMO 2014 (asbtr. 1229PD).

  23. MPDL3280A Phase Ia: Response by Smoking and Mutational Status Smoking Status (NSCLC; n = 53) Response by Smoking Status (ORRa) Former / Current Smokers Pts With PR, % 1/10 11/43 Never Smokers Response by EGFR Status (ORRa) EGFR Status (NSCLC; n = 53) Pts With PR, % Unknown 9/40 1/6 EGFR Mutant Response by KRAS Status (ORRa) KRAS Status (NSCLC; n = 53) Unknown Pts With PR, % 1/10 8/27 KRAS Mutant a ORR includes investigator-assessed u/c PR by RECIST 1.1. Patients first dosed at 1-20 mg/kg by Oct 1, 2012. Data cutoff: Apr 30, 2013.

  24. Treatment Effect on OS in Predefined Subgroups

  25. EGFR OVEREXPRESSION AND MHC I LOSS Herbst Lancet 2015

  26. Pembro: Immune-Related Events & Steroids KEYNOTE-001, Data from 505 pts • PFS and OS and Steroids Use to Manage Immune-Mediated AEs Leighl N ORAL31.02

  27. Clinical Factors: IMMUNOTHERAPY-How to select patients Steroids ? Steroid use and ipilimumab responses by mWHO criteria 29 Baurain JF, J Clin Oncol 2012

  28. AGENDA • LOOKING FOR A BIOMARKER • CLUES IN THE CLINICAL SETTING • BEYOND THE CLINICAL PERSPECTIVE

  29. Clinically Meaningful Outcomes in Clinical Trials in Cancer: an ASCO Cancer Research Committee Initiative <br />Ellis, et al., JCO 32:1277, 2014 Presented By Lowell Schnipper at 2015 ASCO Annual Meeting

  30. Slide 20 Presented By Lowell Schnipper at 2015 ASCO Annual Meeting

  31. Slide 10 Presented By Elisabeth De Vries at 2015 ASCO Annual Meeting

  32. SUSTAINABILITY

  33. UNSUSTAINABLE

  34. Immune Checkpoint Therapy: What Is Next? Anti–PD-1/PD-L1 Your favorite treatment The future of cancer therapy

  35. Sex ♀/♂ Age > 18 PDL1+ (strong) Smoker KRAS mut Steroid free Director (CEO) > 200000 €/y

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