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Inmunoterapia y cancer version ampliada
- 2. Lesterhuls WJ, et al2 and Kirkwood JM, et al. J Clin Oncol. 2008;26(20):3445-3455.
- 4. Immunology and tumors Tumoral Changes Normal Tissue I.S. Response Tolerance I.S Response Adaptative Innate
- 5. Immunity •Humoral Immunity: Lack •Celular Immunity: Correct •Citotoxic T Cells •NK •Antineoplasic chemokines
- 6. Overview of tumor-specific immune response and components targeted by individual immunotherapies
- 9. Anti CTLA4
- 10. <br />Durable clinical responses are seen with anti-CTLA-4 treatment Presented By Lawrence Fong at 2014 ASCO Annual Meeting
- 11. -All AEs were higher in ipilimumab+DTIC (AST and ALT , diarrhea, pruritus and rash) -Grade 3 or 4 adverse events occurred in 56.3% with ipilimumab+DTIC vs 27.5% twith DTIC p<0.001 (gastrointestinal . -The most common AE was immune related (77%) OS PFS DURATION OF RESPONSE
- 17. Side effect does not depend on dose
- 22. Anti-PD-1 antibody (MK-3475- Pembrolizumab Anti-PD-1L antibody (MPDL3280A)
- 23. N: 834p •Phase III •Advanced Melanoma. •Received no more than one previous systemic therapy R 1:1:1 Pembrolizumab 10mg/Kg every 2w Pembrolizumab 10mg/Kg every 3w Ipilimumab 3mg/Kg every 3w EP1: •PFS •OS Keynote-006
- 24. Nivo 2W Nivo 3W Ipi 3W ORR 34% 33% 11.9 % CR: 5% 6% 1% mTimes to response 86d 85d 87d mTime to exposure 164d 151d 50d AE G3-5 13% 10% 19% Fatigue 20% 19% 15% Diarrhea 16% 14% 22% Rash Prurito 15% 14% 13% 14% 15% 25% Inmune Related AE Nivo 2W Nivo 3W Ipi 3W Hypothyroidism 10% 8.7% 2% Hyperthyroidism 7% 3% 3% Colitis 2% 4% 8% Hepatitis 1% 2% 1% Hypophysis 0.4% 0.7% 2% Pneumonitis 0.4% 2% 0.4% Uveitis 0.4% 1% 0% Myositis Nephritis 0 0 1% 0.4% 0.4% 0.4%
- 25. mPFS: 5.5m for 2W (95% [CI], 3.4m to 6.9m) 4.1m for 3W (95% CI, 2.9m to 6.9m) 2.8m for IPI (95% CI, 2.8m to 2.9m). HR for PFS : 0.58 (95% CI, 0.46 to 0.72; P<0.001) 2- week regimen and 0.58 (95% CI, 0.47 to 0.72; P<0.001) 3- week regimen 1Y survival : 74.1% (2W)HR: 0.63; 95% CI, 0.47 to 0.83; P<0.0005), 68.4% (3W)HR: 0.69; 95% CI, 0.52 to 0.90; P = 0.0036), 58.2% for ipilimumab
- 26. Combination
- 28. ORR: 52%-61% vs 10%-11% DCR: 65%-73% vs 20%-46%
- 30. Select Adverse Events and Their Management with Immunomodulatory Medication (IMM), According to Organ Category
- 31. •N: 140p->117p •Phase 2 Trial •Multicentric •2 or more treatments •SQ-NSCLC EIII-IV •Disiase mesurable by image NIVOLUMAB 3mg/Kg Every 2 weeks (1 cicle) Objectives -EP1:Objective response (IRC) -EP2: Objective response Investigator assessed (IA) -Other EP: PK, exposure efficacy and safety, tolerability, PFS, OS * Treatment after progression was permitted if a patient had investigatorassessed clinical benefi t (continuing disease or symptom control despite radiographic progression), stable performance status, and was tolerating nivolumab. •PD * •Unacceptable toxiciy
- 32. Responses: IRC IA CR 0 1% (1p) PR 15% (17p) 12% (14p) SD 26% (30p) 32% ORR: 13%-15% Disease control 41%-45%
- 33. •1-year survival rate was 41% and mOS was 8.2 months •26%p SD-> 6 months •Responses were independent of PD-L1 status
- 34. CheckMate-017(Nivolumab vs Docetaxel) Nivolumab improved OS by 41% versus docetaxel (9.2 vs 6.0 months; HR = 0.59; 95% CI, 0.44- 0.79; P = .00025). The manufacturer of nivolumab is working on publication and presentation of the study data. N: 272p Pre-treated Advanced or M1 SC NSCLC N: 135 Nivolumab 3mg/Kg IV every 2w R N: 137 Docetaxel 75mg/m2 IV every 3 weeks
- 36. Progression-free survival Presented By Robert Motzer at 2014 ASCO Annual Meeting
- 37. Slide 13 Presented By Robert Motzer at 2014 ASCO Annual Meeting
- 38. Duration of response Presented By Robert Motzer at 2014 ASCO Annual Meeting
- 39. Overall survival Presented By Robert Motzer at 2014 ASCO Annual Meeting
- 41. Biomarkers
Editor's Notes
- Adverse events (AEs) of all types and grades occurred in 74% of patients; however, 85% of patients were able to receive at least 90% of their planned dose intensity. Grade 3/4 drug-related AEs were reported in 17% of patients. The most common (≥2%) grade 3/4 AEs were fatigue (4.3%), pneumonitis (3.4%), and diarrhea (2.6%). Discontinuations due to drug-related AEs of any grade occurred in 12% of patients. Two drug-related deaths (1 hypoxic pneumonia, 1 ischemic stroke) occurred in patients with multiple comorbidities and progressive disease - See more at: http://www.onclive.com/web-exclusives/FDA-Approves-Nivolumab-for-NSCLC#sthash.UKDzc98c.dpuf
- 272 previously treated patients with advanced or metastatic squamous cell NSCLC. Participants were randomized to the fully human IgG4 monoclonal antibody nivolumab at 3 mg/kg intravenously every 2 weeks (n = 135) or docetaxel at 75 mg/m2 (n = 137) intravenously every 3 weeks.Treatment with Beyond the primary OS endpoint, secondary endpoints included progression-free survival and objective response rate (ORR). - See more at: http://www.onclive.com/web-exclusives/FDA-Approves-Nivolumab-for-NSCLC#sthash.UKDzc98c.dpuf