Optimizing Immunotherapy New Approaches, Biomarkers, Sequences and Combinations Immunotherapy in the clinic Melanoma
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1 Optimizing Immunotherapy New Approaches, Biomarkers, Sequences and Combinations Immunotherapy in the clinic Melanoma Dr. J.L.Manzano S. Oncología Médica H. Germans Trias i Pujol, ICO-Badalona PRBB Auditorium, Barcelona 20 de Octubre del 2017 ICO Badalona Servei Oncologia Mèdica
2 Metastatic Melanoma: Overall Survival 73% Ugurel S et al. Eur J Cancer 2016;53:
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5 Selection of treatment in melanoma Co-morbilities Brain mets ECOG BRAF Tumor burden Resectability LDH
6 CTLA-4 and PD-1/L1 Checkpoint Blockade for Cancer Treatment Ribas A. N Engl J Med. 2012;366:
7 Ipilimumab induces durable tumor responses in a subset of patients OS Ipi vs gp vs 6.4 m HR:0.66 p:0.003 OS 3 y: 25% OS Ipi+DTIC vs DTIC 11.2 vs 9.1 m HR:0.72 3y: 21% N Engl J Med Aug 19;363(8): N Engl J Med Jun 30;364(26):
8 Pooled OS Analysis Including EAP Data: 4846 Patients Proportion of patients alive (%) Ipilimuma bcensore D Median OS, months (95% CI): 11.4 ( ) 3-year OS rate, % (95% CI): 22 (20 24) Patients at Risk Ipilimuma b Month s Schadendorf D, et al. Presented at ECC 2013: oral 24LBA
9 Keynote-006 Phase III: Pembrolizumab vs Ipilimumab Presented By Jacob Schachter at 2016 ASCO Annual Meeting
10 Keynote-006 Phase III: Characteristics Presented By Jacob Schachter at 2016 ASCO Annual Meeting
11 Keynote-006 Phase III: Overall Survival Presented By Jacob Schachter at 2016 ASCO Annual Meeting
12 Keynote-006 Phase III: AES Presented By Jacob Schachter at 2016 ASCO Annual Meeting
13 Keynote-006 Phase III: Discontinuation
14 Keynote % Presented By Caroline Robert at 2017 ASCO Annual Meeting
15 CA : Nivolumab in Previously Untreated Melanoma without BRAF Mutation NIVO (N = 210) DTIC (N = 208) Age, years Median (range) 64 (18 86) 66 (26 87) Gender, % Male ECOG performance status, % M-stage, % M0/M1a/M1b M1c Baseline LDH level, % ULN > ULN PD-L1 status, % Positive ( 5% expression) Negative/indeterminate 65 64
16 CA : Overall Survival Robert C et al. N Engl. J. Med 2014
17 CA : Safety data NIVO (N = 206) DTIC (N = 205) Patients reporting AE, % a Any grade Grade 3 4 Any grade Grade 3 4 All treatment-related select AEs Skin Pruritus 22 <1 5 0 Rash 18 <1 3 0 Gastrointestinal <1 Diarrhea 18 <1 16 <1 Colitis 2 <1 0 0 Hepatic Elevated ALT <1 Elevated AST 2 <1 2 <1 Endocrine Hypothyroidism Hyperthyroidism 3 <1 0 0 Pulmonary 3 <1 0 0 Pneumonitis 2 <1 0 0 Renal 2 <1 <1 0 Renal failure NIVO (N = 206) DTIC (N = 205) Patients reporting AE, n (%) Any grade Grade 3 4 Any grade Grade 3 4 Treatment-related 159 (77) 27 (13) 159 (78) 35 (17) Treatment-related leading to discontinuation 12 (6) 7 (3) 7 (3) 4 (2) Robert C et al. N Engl. J. Med 2014
18 Presented By Jedd Wolchok at 2016 ASCO Annual Meeting
19 Baseline Patient Characterisitics Presented By Jedd Wolchok at 2016 ASCO Annual Meeting
20 CA : Progression Free Survival Larkin J, AACR May 2017, Abst CT-075
21 CA : Overall Survival Wolchok JD et al, N Engl J Med 2017; 377:
22 Updated Response to treatment Larkin J, AACR May 2017, Abst CT-075
23 Subsequent Therapies: All randomized Patients Larkin J, AACR May 2017, Abst CT-075
24 Mono vs Combo Immunotherapy
25 CA OS: Benefit in BRAFm Larkin J, AACR May 2017, Abst CT-075
26 CA OS: Similar outcomes in PD-L1 1% Larkin J, AACR May 2017, Abst CT-075
27 CA : Selected related AEs Larkin J, AACR May 2017, Abst CT-075
28 CA : Phase IIIb/IV, Randomized, Double Blinded OP: AEs OS: ORR, PFS, OS, QoL
29 Questions? How long to treat with anti-pd-1? Sequences: BRAFi/Anti PD-1 first? New Combos: Triplets, IDOi Selection treatment: Biomarkers 29
30 Robert C et al ESMO 2017 (oral presentation)
31 Robert C et al ESMO 2017 (oral presentation)
32 Presented By Michael Atkins at 2015 ASCO Annual Meeting
33 33 TRIPLETS
34 Selection of treatment in melanoma Co-morbilities Brain mets ECOG BRAF Tumor burden Resectability LDH
35 Many avenues are explored<br />to overcome the resistance Presented By Caroline Robert at 2017 ASCO Annual Meeting
36 Conclusions Anti-PD-1/CTL4 Anti-PD-1 better than Anti-CTL4 (RR,PFS,OS) Anti-PD-1 showed longer survivors (OS 3y 43%). AntiPD-1 more favourable than Anti-CTL4. Combo Ipi+Nivo: Benefit OS(descriptive analysis), exploratory data OS (BRAFm, PDL-1-), Higher toxicity. Selection treatment: Based clinical characterisitics, not selection by biomarkers (PDL-1 weak biomarker)
37 @ICOnoticies Institut Català d Oncologia ICO l Hospitalet Hospital Duran i Reynals Av. Granvia de L Hospitalet, L Hospitalet de Llobregat ICO Badalona Hospital Germans Trias i Pujol Ctra. del Canyet s/n Badalona ICO Girona Hospital Doctor Trueta Av. França s/n Girona ICO Camp de Tarragona i Terres de l Ebre Hospital Joan XXIII C. Dr. Mallafrè Guasch, Tarragona Hospital Verge de la Cinta C. de les Esplanetes, Tortosa
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62 Genomic and Expression Profiles Associated with PD-1 Resistance: IPRES Presented By Jeffrey Weber at 2017 ASCO Annual Meeting
63 Slide 9 Presented By Jeffrey Weber at 2017 ASCO Annual Meeting
64 Copy number alterations of IFN-gamma genes associated with resistance to CTLA-4 blockade Presented By Jeffrey Weber at 2017 ASCO Annual Meeting
65 Mutational burden associated with clinical benefit of PD-1 blockade Presented By Jeffrey Weber at 2017 ASCO Annual Meeting
66 JAK 1/2 mutations associated with acquired resistance to PD-1 blockade Presented By Jeffrey Weber at 2017 ASCO Annual Meeting
67 Composite tumor burden and PD-1+/CD8 T cells are associated with PD-1 response Presented By Jeffrey Weber at 2017 ASCO Annual Meeting
68 Slide 23 Presented By Jeffrey Weber at 2017 ASCO Annual Meeting
69 Slide 24 Presented By Jeffrey Weber at 2017 ASCO Annual Meeting
70 Working model: immunobiology of T cell-inflamed and non-inflamed tumor microenvironment Presented By Thomas Gajewski at 2017 ASCO Annual Meeting
71 Genetic resistances to immunotherapies Presented By Caroline Robert at 2017 ASCO Annual Meeting
72 Innate anti-pd-1 signature (IPRES)<br /> for primary resistance Presented By Caroline Robert at 2017 ASCO Annual Meeting
73 Slide 13 Presented By Kurt Schalper at 2017 ASCO Annual Meeting
74 Slide 23 Presented By Suzanne Topalian at 2017 ASCO Annual Meeting
75 TRACTAMENTS
76 Institut Català d Oncologia ICO l Hospitalet Hospital Duran i Reynals Av. Granvia de L Hospitalet, L Hospitalet de Llobregat ICO Badalona Hospital Germans Trias i Pujol Ctra. del Canyet s/n Badalona ICO Girona Hospital Doctor Trueta Av. França s/n Girona ICO Camp de Tarragona i Terres de l Ebre Hospital Joan XXIII C. Dr. Mallafrè Guasch, Tarragona Hospital Verge de la Cinta C. de les Esplanetes, Tortosa
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