Índice. Melanoma Cáncer de Pulmón Otros tumores
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- Ann Cunningham
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4 Índice Melanoma Cáncer de Pulmón Otros tumores Carcinoma de Vejiga Carcinoma de Células Renales Carcinoma de Cabeza y Cuello Carcinomas del tubo digestivo Cáncer de Mama
5 MELANOMA
6 CIRUGÍA CIRUGÍA + INFa Tto Sistémico
7 INMUNOTERAPIA: INHIBIDOR DE CTLA4
8 Varón 87 años. Melanoma metastásico (cutánides, pulmonares y hepáticas)
9 Respuesta a Ipilimumab
10 Respuesta tras Ipilimumab Ipi x 4 ciclos
11 NIVOLUMAB : FASE 3 1ª linea Nivolumab (N = 210) Dacarbazine (N = 208) ORR, % (95% CI) 40% (33 47%) 14% (10 19%) Best overall response Complete response 8% 1% Partial response 32% 13% Stable disease 17% 22% Progressive disease 33% 49% Unable to determine 11% 15% Robert C. et al NEJM Novenmber 2014
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16 Updated Results From a Phase III Trial of Nivolumab Combined With Ipilimumab in Treatment-naïve Patients With Advanced Melanoma (Checkmate 067) Jedd D. Wolchok, 1 Vanna Chiarion-Sileni, 2 Rene Gonzalez, 3 Piotr Rutkowski, 4 Jean-Jacques Grob, 5 C. Lance Cowey, 6 Christopher D. Lao, 7 Dirk Schadendorf, 8 Pier Francesco Ferrucci, 9 Michael Smylie, 10 Reinhard Dummer, 11 Andrew Hill, 12 John Haanen, 13 Michele Maio, 14 Grant McArthur, 15 Dana Walker, 16 Joel Jiang, 16 Christine Horak, 16 James Larkin, 17* F. Stephen Hodi 18* ASCO 2016
17 Randomized, double-blind, phase III study to compare NIVO+IPI or NIVO alone to IPI alone Unresectab le or Metatastic Melanoma Previously untreated 945 patients Random ize 1:1:1 Stratify by: Tumor PD-L1 express ion a BRAF mutation status AJCC M stage N = 314 N = 316 N = 315 NIVO 1 mg/kg + IPI 3 mg/kg Q3W for 4 doses then NIVO 3 mg/kg Q2W NIVO 3 mg/kg Q2W + IPImatched placebo IPI 3 mg/kg Q3W for 4 doses + NIVO-matched placebo Treat until progressi on b or unaccept able toxicity a Verified PD-L1 assay with 5% expression level was used for the stratification of patients; validated PD-L1 assay was used for efficacy analyses ASCO 2016 bpatients could have been treated beyond progression under protocol-defined circumstances
18 RESPUESTA AL TRATAMIENTO a By RECIST v1.1 NR = not reached NIVO + IPI (N = 314) NIVO (N = 316) IPI (N = 315) ORR, % (95% CI) a 57.6 (52.0, 43.7 (38.1, 19.0 (14.9, 63.2) 49.3) 23.8) Two-sided P value vs IPI <0.001 < Best overall response, % Complete response Partial response Stable disease Progressive disease Unknown Median duration of response, months (95% CI) Ongoing response among responders, % NR (20.5, 22.3 (20.7, 14.4 (8.3, NR) NR) NR)
19 Progression-Free Survival (Intent-to- Treat Population) F S P of Progression-free Survival (%) a g e c e n NIVO+ IPI NIVO IPI PFS per Investigator (months) 18 NIVO + IPI (N = NIVO (N = IPI (N = 315) 314) 316) Median PFS, months 11.5 (8.9, 6.9 (4.3, 9.5) 2.9 (2.8, 3.4) (95% CI) 16.7) HR (99.5% CI) vs. IPI 0.42 (0.31, 0.55 (0.43, ) a 0.76) a HR (95% CI) vs. NIVO 0.76 (0.60, 0.92) b % 42 % 18 % 46 % 39 % 14 % 2 1 a Stratified log-rank P< vs. IPI Number of patients at risk: Nivolumab Ipilimumab Nivolum ab Ipilimum ab 2 4 b Exploratory endpoint 2 7
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25 CARCINOMA PULMONAR
26 CIRUGÍA QT/RT SistémicoPa liativo
27 NIVOLUMAB FASE 3 CheckMate 017 2ªLINEA NSCLC ( Squamous) ESMO 2015
28 NIVOLUMAB CheckMate 017 ESMO 2015
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31 NIVOLUMAB CheckMate 057 ESMO 2015
32 CASO 1. Carcinoma Epidermoide de Pulmón en tratamiento con Nivolumab CASO 2. Adenocarcinoma de Pulmón en tratamiento con Nivolumab
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34 ATEZOLIZUMAB FASE 2 NSCLC Study BIRCH Besse B, et al ESMO 2015
35 ATEZOLIZUMAB Study BIRCH Besse B, et al ESMO 2015
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54 CARCINOMA RENAL
55 CA : Phase III, randomized, open-label trial of nivolumab vs everolimus in subjects with advanced or metastatic clear cell RCC who have received prior antiangiogenic therapy N=82 Key Inclusion Criteria 2Advanced/metastatic clear cell RCC No more than 3 total prior regimens in advanced/metastatic setting 1 or 2 prior antiangiogenic therapy regimens in advanced/metastatic setting Karnofsky PS 70% No CNS metastases No prior therapy with mtor inhibitor No autoimmune disease Nivolumab Median OS, months (95% CI) 25.0 (21.8 NE) Everolimus 19.6 ( ) Adapted from Motzer et al, 2015, N Engl J Med. R 1:1 Overall Survival (Probability) Nivolumab 3 mg/kg IV q2w Everolimus 10 mg PO qd Until progression *, unacceptabl e toxicity, withdrawal of consent, or end of trial Primary Outcome Measure: OS Secondary Outcome Measures: PFS, ORR, duration of objective response, duration of OS by PD-L1 status, safety, disease-related symptom progression rate Everolimus Nivolumab Months # of patients at risk Nivolumab Everolimus CNS = central nervous system; IV = intravenous; mtor = mammalian target of rapamycin; ORR = objective response rate; OS = overall survival; PD-L1 = programmed death ligand-1; PFS = progression-free survival; PO = by mouth; PS = performance status; q2w = every 2 weeks; R = randomized; RCC = renal cell carcinoma.
56 CA : Phase III, randomized, open-label trial of nivolumab vs everolimus in subjects with advanced or metastatic clear cell RCC who have received prior antiangiogenic therapy Survival benefit with nivolumab was irrespective of PD-L1 expression Overall Survival (Probability) Everolimus PD-L1 1% (n = 24%) PD-L1 <1% (n = 76%) Median OS, months (95% CI) Nivolumab 21.8 ( ) Everolimus 18.8 ( ) Nivolumab Median OS, months (95% CI) Nivolumab 27.4 (21.4 NE) Everolimus 21.2 ( ) Everolimus Nivolumab Months # of patients at risk Nivolumab Everolimus Months Adapted from Motzer et al, 2015, N Engl J Med. Based on data cut-off of June CI = confidence interval; HR = hazard ratio; NE = not estimable; mrcc = metastatic renal cell carcinoma; OS = overall survival; PD-L1 = programmed death ligand
57 CARCINOMA UROTELIAL
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59 Efficacy<br />Reduction in Tumor Burden Presented By Robert Dreicer at 2016 ASCO Annual Meeting
60 Efficacy<br />Time to Response Presented By Robert Dreicer at 2016 ASCO Annual Meeting
61 Efficacy<br />Duration of Treatment and Response Presented By Robert Dreicer at 2016 ASCO Annual Meeting
62 IMvigor210 Study: Cohort 1 Presented By Arjun Balar at 2016 ASCO Annual Meeting
63 Baseline Characteristics<br />Representative of the cisplatin-ineligible population Presented By Arjun Balar at 2016 ASCO Annual Meeting
64 Efficacy<br />Response to Atezolizumab (IRF RECIST v1.1) Presented By Arjun Balar at 2016 ASCO Annual Meeting
65 Efficacy<br />Change in Tumor Burden Presented By Arjun Balar at 2016 ASCO Annual Meeting
66 Efficacy<br />Response by Baseline Characteristic Presented By Arjun Balar at 2016 ASCO Annual Meeting
67 Efficacy<br />Overall Survival (Median and Landmark 12-Month OS) Presented By Arjun Balar at 2016 ASCO Annual Meeting
68 Efficacy<br />Overall Survival (Median OS) by PD-L1 Status Presented By Arjun Balar at 2016 ASCO Annual Meeting
69 CARCINOMA CABEZA Y CUELLO
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79 Próximas indicaciones de Anti-PDL1/Anti-PD1 Hodgkin Lymphoma 1 Hepatocellular Carcinoma 2 Ovarian Cancer 3 Urothelial Cancer 4 Small Cell Lung Cancer 5 (Nivolumab 1 mg/kg BW + Ipilimumab 3 mg/kg BW) Colorectal Cancer MSI-H 6 (Nivolumab 3 mg/kg BW + Ipilimumab 1 mg/kg BW) Gastric Cancer 7 (Nivolumab 1 mg/kg BW + Ipilimumab 3 mg/kg BW) Esophageal Cancer 8 Younes et al. Oral presentation at ASCO 2016, Abstract Sangro et al. Oral presentation at ASCO 2016, Abstract Hamanishi et al. J Clin Oncol. 2015, 33(34): Sharma et al. Oral presentation at ASCO 2016, Abstract Antonia et al. Oral presentation at ASCO 2016, Abstract 100. Overman et al. Oral presentation at ASCO 2016, Abstract Janjigian et al. Oral presentation at ASCO 2016, Abstract Ura et al. Poster presentation at ESMO 2015, Abstract 2301
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Cancer Immunotherapy: an Emerging Paradigm
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