REVISION DE LOS DATOS ACTUALES DE INMUNOTERAPIA EN MELANOMA. Miguel Ángel Cabrera Suárez Oncología médica HUNSC
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3 REVISION DE LOS DATOS ACTUALES DE INMUNOTERAPIA EN MELANOMA Miguel Ángel Cabrera Suárez Oncología médica HUNSC
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5 Inmunoterapia en Melanoma Miguel Ángel Cabrera Suárez Oncologia médica HUNSC
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7 EL PASADO: SUPERVIVIENCIA EN PACIENTES CON ENFERMEDAD AVANZADA
8 SUPERVIVIENCIAS S al año 25-30% 71% Pembro a 74% Dab + Tram 75% Vem +Cobi 79% Nivo +Ipi
9 SUPERVIVIENCIAS S al año 25-30% 71% Pembro a 74% Dab + Tram 75% Vem +Cobi 79% Nivo +Ipi S 2 años 24% 28.5% 45%Nivo 58% 49% Pembro FI 48% Vem + Tram 53% Dab +Cobi 64% Nivo + IPI
10 SUPERVIVIENCIAS S al año 25-30% 71% Pembro a 74% Dab + Tram 75% Vem +Cobi 79% Nivo +Ipi S 2 años 24% 28.5% 45%Nivo 58% 49% Pembro FI 48% Vem + Tram 53% Dab +Cobi 64% Nivo + IPI S 3 años 22% 42%Nivo FI
11 SUPERVIVIENCIAS S al año 25-30% 71% Pembro a 74% Dab + Tram 75% Vem +Cobi 79% Nivo +Ipi S 2 años 24% 28.5% 45%Nivo 58% 49% Pembro FI 48% Vem + Tram 53% Dab +Cobi 64% Nivo + IPI S 3 años 22% 42%Nivo FI S 5 años 18% 34%
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13 Cell , DOI: ( /j.cell ) Figure 1
14 Cell , DOI: ( /j.cell ) Figure 2
15 Cell , DOI: ( /j.cell ) Figure 3
16 Cell , DOI: ( /j.cell ) Figure 4
17 Cell , DOI: ( /j.cell ) Figure 5
18 Cell , DOI: ( /j.cell ) Figure 6
19 Inmunoterapia vs Tratamientos diana
20 Cinética de las respuestas
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22 Desarrollo de los inhibidores en melanoma 1 st pembrolizumab ph 3 data 8 Melanoma data milestones 1 st NIVO+IPI regimen ph 3 data 7 1 st IPI ph 1 data 1 1 st NIVO+IPI regimen ph 2 data 18 IPI ph 3 data 15 1 st IPI ph 3 data 2 IPI pooled OS data 16 1 st NIVO ph 3 data 6,17 1 st NIVO ph 1 data3 1 st NIVO+IPI regimen ph 1 data 4 1st pembrolizumab ph 1 data Regulatory milestones IPI US and EU approval 9 July: NIVO approved in Japan 12 Sept: Pembrolizumab approved in US 11 Dec: NIVO approved in US 10 June: NIVO approved in EU 13 May: Positive CHMP opinion for pembrolizumab in EU 14 a Only approved agents and selected data milestones are included. 1. Hodi FS, et al. Proc Natl Acad Sci. 2003;100: Hodi FS, et al. N Engl J Med. 2010;363: Brahmer JR, et al. J Clin Oncol. 2010;28: Wolchok JD, et al. N Engl J Med 2013;369: Hamid O, et al. N Engl J Med. 2013;369: Robert C, et al. N Engl J Med. 2014:doi: /NEJMoa Larkin J, et al. N Engl J Med. 2015; DOI: /NEJMoa Robert C, et al. N Engl J Med. 2015; DOI: /NEJMoa Wolchok J, Ann N Y Acad Sci 2013;1291: FDA Press release.22 Dec FDA Press release 4 Sept Ono Pharmaceutical Co. Press release 4 July BMS Press release 19 June Merck Press release 22 May Robert C, et al. N Engl J Med. 2011;364: Schadendorf D, et al. J Clin Oncol. 2015;33: Weber J, et al. Presented at ESMO 2014 abstract LBA3_PR. 18. Hodi FS, et al. Presented at ASCO 2015 abstract 9004.
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24 Cuestiones
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26 Response rates & survival outcomes of NIVOLUMAB in clinical trials
27 NIVOLUMAB : FASE 1 Hodi SMR Nov-2014
28 NIVOLUMAB FASE 1: Estudio CA Dose, mg/kg ORR, %, (n/n) Median Duration of Response, months (range) All doses 32 (34/107) 23 (4 32) (6/17) 10 (6 27+) (5/18) 32 (4 32) 1 34 (12/35) 24 (8 31+) 3* 41 (7/17) 22 (9 27+) (4/20) 26 (17 27+) Hodi SMR Nov-2014
29 NIVOLUMAB FASE 1: Estudio CA Overall Survival ay 5 Years of Follow-up All Patients (events: 69/107), median and 95% CI: 17.3 ( ) NIVO 3 mg/kg (events: 11/17), median and 95% CI: 20.3 (7.2 NR) Probability of Survival Months Number of Patients at Risk All Patients NIVO 3 mg/kg AACR 2016 Database lock Oct 2015
30 NIVOLUMAB Estudio CA Seguridad Treatment-Related Immune- Mediated Adverse Events Category Any immunemediated AE Any Grade, % (n) Grade 3-4, % (n) 54 (58) 5 (5) Skin 36 (38) 0 Gastrointestinal 18 (19) 2 (2) Endocrinopathies 13 (14) 2 (2) Hepatic 7 (7) 1 (1) Infusion reaction 6 (6) 0 March 2013 data analysis; no new safety analysis in the September 2014 database lock 1.Topalian S, et al. J Clin Oncol. 2014
31 NIVOLUMAB : FASE 3 1ª linea (CheckMate066) Estratificados seg PD-L1 (35% ->5%) M (0,1ª,1b,1c) 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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33 NIVOLUMAB 1ª linea SUPERVIVENCIA GLOBAL SG según expresión PDL-1 Robert C. et al NEJM Novenmber 2014
34 NIVOLUMAB 1ª linea
35 NIVOLUMAB : FASE 3 2ª linea (CheckMate 037) NIVOLUMAB ORR 32% QUIIMIOTERAPIA ORR 11% Weber Lancet 2015
36 NIVOLUMAB : FASE 3 2ª linea
37 Primera linea CheckMate 067
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42 Response rates & survival outcomes of PEMBROLIZUMAB in clinical trials
43 PEMBROLIZUMAB : FASE 1 Ribas ASCO 2014
44 PEMBROLIZUMAB FASE 1: KEYNOTE 001 Ribaas ASCO SUPERVIVENCIA GLOBAL SUPERVIVENCIA 1ª Linea IPI previo 52% BRAFi previo Mediana de seguimiento 15 M Daud, ASCO 2015, abs 9005
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46 PEMBROLIZUMAB KEYNOTE 001 Respuestas en relación expresión PDL1 Daud, ASCO 2015, abs 9005
47 PEMBROLIZUMAB KEYNOTE 001 Perfil de Seguridad
48 PEMBROLIZUMAB KEYNOTE 002 Randomización : ECOG, niveles LDH y estado mutacional BRAF Lancet Oncol 2015:
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50 PEMBROLIZUMAB : FASE 3 KEYNOTE 006
51 PEMBROLIZUMAB KEYNOTE 006 J Schachter SMR 2015 J Schachter SMR 2015
52 PEMBROLIZUMAB KEYNOTE 006 SLP/SG Progression-Free Survival (RECIST v1.1, central review) P < J Schachter SMR 2015
53 Que nos ha dado ASCO/ESMO 2016
54 KEYNOTE-006: OS and PFS OS 12-Mo OS, % 24-Mo OS, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Median OS, Mos (Range) NR (22.1-NR) NR (23.5-NR) 16.0 ( ) Events, n HR (95% CI) P Value 0.68 ( ) 0.68 ( ) PFS* 12-Mo PFS, % 24-Mo PFS, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Median PFS, Mos (Range) 5.6 ( ) 4.1 ( ) 2.8 ( ) Events, n HR (95% CI) P Value Ipilimumab outperformed expectations based on historical data for OS, making survival advantage with pembrolizumab less dramatic OS advantage with pembrolizumab was consistent across subgroups ( ) 0.61 ( ) < < *RECIST v1.1 by ICR. P values nominal because no statistical alpha applied to comparison at final analysis. Final data cutoff December 3, Schachter J, et al. ASCO Abstract 9504.
55 KEYNOTE-006: OS and PFS OS 12-Mo OS, % 24-Mo OS, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Median OS, Mos (Range) NR (22.1-NR) NR (23.5-NR) 16.0 ( ) Events, n HR (95% CI) P Value 0.68 ( ) 0.68 ( ) PFS* 12-Mo PFS, % 24-Mo PFS, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Median PFS, Mos (Range) 5.6 ( ) 4.1 ( ) 2.8 ( ) Events, n HR (95% CI) P Value Ipilimumab outperformed expectations based on historical data for OS, making survival advantage with pembrolizumab less dramatic OS advantage with pembrolizumab was consistent across subgroups ( ) 0.61 ( ) < < *RECIST v1.1 by ICR. P values nominal because no statistical alpha applied to comparison at final analysis. Final data cutoff December 3, Schachter J, et al. ASCO Abstract 9504.
56 KEYNOTE-006: OS and PFS OS 12-Mo OS, % 24-Mo OS, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Median OS, Mos (Range) NR (22.1-NR) NR (23.5-NR) 16.0 ( ) Events, n HR (95% CI) P Value 0.68 ( ) 0.68 ( ) PFS* 12-Mo PFS, % 24-Mo PFS, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Median PFS, Mos (Range) 5.6 ( ) 4.1 ( ) 2.8 ( ) Events, n HR (95% CI) P Value Ipilimumab outperformed expectations based on historical data for OS, making survival advantage with pembrolizumab less dramatic OS advantage with pembrolizumab was consistent across subgroups ( ) 0.61 ( ) < < *RECIST v1.1 by ICR. P values nominal because no statistical alpha applied to comparison at final analysis. Final data cutoff December 3, Schachter J, et al. ASCO Abstract 9504.
57 KEYNOTE-006: OS and PFS OS 12-Mo OS, % 24-Mo OS, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Median OS, Mos (Range) NR (22.1-NR) NR (23.5-NR) 16.0 ( ) Events, n HR (95% CI) P Value 0.68 ( ) 0.68 ( ) PFS* 12-Mo PFS, % 24-Mo PFS, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Median PFS, Mos (Range) 5.6 ( ) 4.1 ( ) 2.8 ( ) Events, n HR (95% CI) P Value Ipilimumab outperformed expectations based on historical data for OS, making survival advantage with pembrolizumab less dramatic OS advantage with pembrolizumab was consistent across subgroups ( ) 0.61 ( ) < < *RECIST v1.1 by ICR. P values nominal because no statistical alpha applied to comparison at final analysis. Final data cutoff December 3, Schachter J, et al. ASCO Abstract 9504.
58 KEYNOTE-006: OS and PFS OS 12-Mo OS, % 24-Mo OS, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Median OS, Mos (Range) NR (22.1-NR) NR (23.5-NR) 16.0 ( ) Events, n HR (95% CI) P Value 0.68 ( ) 0.68 ( ) PFS* 12-Mo PFS, % 24-Mo PFS, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Median PFS, Mos (Range) 5.6 ( ) 4.1 ( ) 2.8 ( ) Events, n HR (95% CI) P Value Ipilimumab outperformed expectations based on historical data for OS, making survival advantage with pembrolizumab less dramatic OS advantage with pembrolizumab was consistent across subgroups ( ) 0.61 ( ) < < *RECIST v1.1 by ICR. P values nominal because no statistical alpha applied to comparison at final analysis. Final data cutoff December 3, Schachter J, et al. ASCO Abstract 9504.
59 KEYNOTE-006: OS and PFS OS 12-Mo OS, % 24-Mo OS, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Median OS, Mos (Range) NR (22.1-NR) NR (23.5-NR) 16.0 ( ) Events, n HR (95% CI) P Value 0.68 ( ) 0.68 ( ) PFS* 12-Mo PFS, % 24-Mo PFS, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Median PFS, Mos (Range) 5.6 ( ) 4.1 ( ) 2.8 ( ) Events, n HR (95% CI) P Value Ipilimumab outperformed expectations based on historical data for OS, making survival advantage with pembrolizumab less dramatic OS advantage with pembrolizumab was consistent across subgroups ( ) 0.61 ( ) < < *RECIST v1.1 by ICR. P values nominal because no statistical alpha applied to comparison at final analysis. Final data cutoff December 3, Schachter J, et al. ASCO Abstract 9504.
60 KEYNOTE-006: Duration of Response Duration of response similar in all treatment arms Nearly 70% of pts demonstrated no sign of treatment failure at final analysis Arm 12-Mo Response, % 18-Mo Response, % Responders, n Median DoR, Mos (Range) Ongoing Response, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Schachter J, et al. ASCO Abstract NR ( ) NR ( ) NR (1.1+ to 23.8+)
61 KEYNOTE-006: Duration of Response Duration of response similar in all treatment arms Nearly 70% of pts demonstrated no sign of treatment failure at final analysis Arm 12-Mo Response, % 18-Mo Response, % Responders, n Median DoR, Mos (Range) Ongoing Response, % Pembrolizumab Q2W Pembrolizumab Q3W Ipilimumab Schachter J, et al. ASCO Abstract NR ( ) NR ( ) NR (1.1+ to 23.8+)
62 KEYNOTE-029: Pembrolizumab + Ipilimumab in Melanoma Study Phase I trial Dose Run-In (Phase Ia) [1] Pts with advanced melanoma, 0 prior therapies OR pts with advanced RCC, 1 prior therapy Design Pembrolizumab 2 mg/kg Q3W, 24 mos + Ipilimumab 1 mg/kg Q3W x 4 doses Dose Expansion (Phase Ib) [2] Pts with advanced melanoma; ECOG PS 0-1; 0 prior therapies, no prior PD-1, PD- L1, or anti CTLA-4 (N = 153) Dose run-in (phase Ia): dose determined to be tolerable, active based on DLT rate [1] Dose expansion (phase Ib) [2] Primary endpoint: safety Secondary endpoints: DoR, ORR, OS, PFS 1. Atkins MB, et al. ASCO Abstract Long GV, et al. ASCO Abstract 9506.
63 KEYNOTE-029: Response Characteristic Pembrolizumab + Ipilimumab (N = 153) ORR, % (95% CI) 57 (49-65) DCR, % (95% CI) 78 (71-85) Best overall response, % CR 10 PR 47 SD 22 PD 20 No assessment 2 81% of pts experienced some tumor reduction; median change: -54.5% Tumor response in both PD-L1 positive or PD-L1 negative status 98% of responders maintained response at time of data cutoff Robust responses experienced in all subgroups Long GV, et al. ASCO Abstract 9506.
64 KEYNOTE-029: Response Characteristic Pembrolizumab + Ipilimumab (N = 153) ORR, % (95% CI) 57 (49-65) DCR, % (95% CI) 78 (71-85) Best overall response, % CR 10 PR 47 SD 22 PD 20 No assessment 2 81% of pts experienced some tumor reduction; median change: -54.5% Tumor response in both PD-L1 positive or PD-L1 negative status 98% of responders maintained response at time of data cutoff Robust responses experienced in all subgroups Long GV, et al. ASCO Abstract 9506.
65 KEYNOTE-029: Response Characteristic Pembrolizumab + Ipilimumab (N = 153) ORR, % (95% CI) 57 (49-65) DCR, % (95% CI) 78 (71-85) Best overall response, % CR 10 PR 47 SD 22 PD 20 No assessment 2 81% of pts experienced some tumor reduction; median change: -54.5% Tumor response in both PD-L1 positive or PD-L1 negative status 98% of responders maintained response at time of data cutoff Robust responses experienced in all subgroups Long GV, et al. ASCO Abstract 9506.
66 KEYNOTE-029: Conclusiones Combination of pembrolizumab 2 mg/kg + ipilimumab 1 mg/kg appears to have manageable toxicity profile 72% of pts received all 4 doses of ipilimumab Grade 3/4 immune-mediated AEs: 25% No treatment-related deaths Pembrolizumab 2 mg/kg + ipilimumab 1 mg/kg produces robust, durable responses in pts with advanced melanoma ORR: 57% ORR similar across key subgroups Durable response in 98% of pts DoR: 6+ to 43+ wks; 6-mo PFS: 70% Long GV, et al. ASCO Abstract 9506.
67 1 Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy; 2 Medical Oncology, National Cancer Institute, Milan, Italy; 3 Institute Gustave, Roussy, Villejuif, France; 4 Department of Diagnostics and Cancer Immunology, Greater Poland Cancer Centre, Poznan Medical University, Poznan, Poland; 5 Istituto Oncologico Veneto, Padova, Italy; 6 Hospital Clinic, Barcelona, Spain; 7 Aarhus University Hospital, Aarhus, Denmark; 8 AP-HP Dermatology CIC Departments, Saint-Louis Hospital, INSERM U976, Université Paris Diderot, Paris, France; 9 Odense University Hospital, Odense, Denmark; 10 The Angeles Clinic and Research Institute, Los Angeles, CA, USA; 11 Maria Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland; 12 Chris O'Brien Lifehouse and Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia and Melanoma Institute Australia, Sydney, New South Wales, Australia; 13 University Hospital Tübingen, Tübingen, Germany; 14 University Medical Center, Mainz, Germany; 15 Department of Oncodermatology, INSERM Research Unit 892, University Hospital, Nantes, France; 16 Department of Dermatology, Centre Hospitalier Lyon Sud, Pierre-Bénite Cedex, France; Overall Survival and Safety Results From a Phase 3 Trial of Ipilimumab at 3 mg/kg vs 10 mg/kg in Patients With Metastatic Melanoma Ascierto PA, 1 Del Vecchio M, 2 Robert C, 3 Mackiewicz A, 4 Chiarion Sileni V, 5 Arance AM, 6 Schmidt H, 7 Lebbé C, 8 Bastholt L, 9 Hamid O, 10 Rutkowski P, 11 McNeil C, 12 Garbe C, 13 Loquai C, 14 Dreno B, 15 Thomas L, 16 Grob J-J, 17 Hennicken D, 18 Qureshi A, 18 Maio M 19
68 CA : Study Design Previously Treated/Untreat ed Metastatic MEL b (N = 727) Stratification M0 + M1a + M1b vs M1c without brain metastases vs M1c with brain metastases Prior treatment (y/n) ECOG PS (0/1) Randomize 1:1 Week 1 Initial treatment phase IPI 10 mg/kg Q3W 4 (n = 365) IPI 3 mg/kg Q3W 4 (n = 362) Week 24 Re-treatment phase a IPI 10 mg/kg Q3W 4 (n = 23) IPI 3 mg/kg Q3W 4 (n = 32) Enrollment period: March 2012 to August 2012 No crossover allowed between treatment arms a After initial response (or stable disease 3 months) and subsequent progressive disease in the absence of intolerable toxicity. b Patients could not be treated with BRAF/PD-1 therapy. ECOG PS = Eastern Cooperative Oncology Group performance status; Q3W = every 3 87
69 OS: Randomized Patients Alive (%) ber of patients at risk 0 IPI 10 mg/kg IPI 3 mg/kg 54% 48% OS Time (Months) IPI 10 mg/kg n = 365 IPI 3 mg/kg n = 362 Events (%) 262 (72) 279 (77) Median (95% CI), mo 15.7 (11.6, 17.8) 11.5 (9.9, 13.3) HR (95% CI) 0.84 (0.70, 0.99) Log-rank P value % 31% 31% 23% IPI 10 mg/kg IPI 3 mg/kg Minimum OS follow-up: ~43 mo 88
70 OS: Subgroup Analysis IPI 10 mg/kg events/patient s vs IPI 3 mg/kg events/patients Hazard ratio (95% CI) Overall Population 262/ / (0.70, 0.99) Age <65 years 150/ / (0.62, 0.97) 65 years 112/ / (0.77, 1.28) BRAF mutation status Positive 47/80 60/ (0.44, 0.96) Negative 169/ / (0.75, 1.14) Not done 46/60 38/ (0.50, 1.19) M-stage M0/M1a/M1b 84/ / (0.58, 1.04) M1c no brain metastases 124/ / (0.72, 1.18) M1c with brain metastases 54/65 58/ (0.49, 1.04) ECOG PS 0 170/ / (0.65, 0.99) 1 92/103 96/ (0.75, 1.33) Prior systemic treatment No 109/ / (0.65, 1.10) Yes 153/ / (0.69, 1.07) Baseline ULN 151/ / (0.68, 1.07) >ULN 103/ / (0.63, 1.07) mg/kg 2 better ULN 3 mg/kg better 223/ / (0.70, 1.01) >2 ULN 31/34 43/ (0.61, 1.55) 89
71 PFS, ORR, DCR by mwho: Randomized Patients PFS (%) IPI 10 mg/kg IPI 3 mg/kg IPI 10 mg/kg n = 365 IPI 3 mg/kg n = 362 PFS Events (%) 328 (90) 330 (91) Median (95% CI), 2.8 (2.8, 2.8 (2.8, 2.8) mo 3.0) HR (95% CI) 0.89 (0.76, 1.04) Log-rank P 0.16 value ORR % (95% CI) 15 (12, 20) 12 (9, 16) DCR % (95% CI) 32 (27, 37) 28 (23, 33) er of patients at risk Time (Months) IPI 10 mg/kg IPI 3 mg/kg
72 Summary/Conclusions This phase 3 study showed a statistically significant improvement in OS with IPI 10 mg/kg vs IPI 3 mg/kg in patients with MEL who had not received a prior BRAF or checkpoint inhibitor No differences were observed for the secondary endpoints of PFS, ORR, or DCR IPI 10 mg/kg was associated with higher rates of treatment-related AEs and AEs leading to discontinuation Although the treatment landscape has evolved for first-line MEL, the clinical utility of IPI in refractory patients warrants further evaluation 91
73 IPILIMUMAB VS PLACEBO AFTER COMPLETE RESECTION OF STAGE III MELANOMA: FINAL OVERALL SURVIVAL RESULTS FROM THE EORTC RANDOMIZED, DOUBLE-BLIND, PHASE 3 TRIAL Alexander MM Eggermont, 1 Vanna Chiarion Sileni, 2 Jean-Jacques Grob, 3 Reinhard Dummer, 4 Jedd D Wolchok, 5 Henrik Schmidt, 6 Omid Hamid, 7 Caroline Robert, 1 Paolo A Ascierto, 8 Jon M Richards, 9 Céleste Lebbé, 10 Virginia Ferraresi, 11 Michael Smylie, 12 Jeffrey S Weber, 13,* Corina Taitt, 14 Veerle de Pril, 14 Gaetan de Schaetzen, 15 Stefan Suciu, 15 Alessandro Testori 16 1 Gustave Roussy Cancer Campus Grand Paris, Villejuif, France; 2 Oncology Institute of Veneto Istituto di Ricovero e Cura a Carattere Scientifico, Padua, Italy; 3 Aix-Marseille University, Hôpital de La Timone, Marseille, France; 4 University of Zürich Hospital, Zürich, Switzerland; 5 Memorial Sloan Kettering Cancer Center, New York, NY, USA; 6 Aarhus University Hospital, Aarhus, Denmark; 7 The Angeles Clinic and Research Institute, Los Angeles, CA, USA; 8 Istituto Nazionale Tumori Fondazione G. Pascale, Naples, Italy; 9 Oncology Specialists S.C., Park Ridge, IL, USA; 10 Department of Dermatology and Centred Investigation Clinique, U-976 Hôpital Saint Louis, Université Paris Diderot, Paris, France; 11 Istituti Fisioterapici Ospitalieri, Rome, Italy; 12 Cross Cancer Institute, Edmonton, Alberta, Canada; 13 H Lee Moffitt Cancer Center, Tampa, FL, USA; 14 Bristol-Myers Squibb, Princeton, NJ, USA; 15 EORTC Headquarters, Brussels, Belgium; 16 European Institute of Oncology, Milan, Italy. *Current affiliation: Perlmutter Cancer Center at NYU-Langone Medical Center, New York, NY, USA Abstract Number LBA
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75 EORTC 18071/CA : Study Design Randomized, double-blind, phase 3 study evaluating the efficacy and safety of ipilimumab in the adjuvant setting for high-risk melanoma High-risk, stage III, completely resected melanoma N = 951 R N = 475 N = 476 INDUCTION Ipilimumab 10 mg/kg Q3W 4 INDUCTION Placebo Q3W 4 MAINTENANCE Ipilimumab 10 mg/kg Q12W up to 3 years MAINTENANCE Placebo Q12W up to 3 years Stratification factors Stage (IIIA vs IIIB vs IIIC 1-3 positive lymph nodes vs IIIC 4 positive lymph nodes) Regions (North America, European countries, and Australia) Enrollment Period: June 2008 to July 2011 Week 1 Week 12 Week 24 Treatment up to a maximum of 3 years, or until disease progression, intolerable toxicity, or withdrawal Q3W = every 3 weeks; Q12W = every 12 weeks; R = randomization.
76 Patients Alive (%) Comparison of Impact on OS: EORTC IFN vs Ipilimumab Experience IFN/PEG-IFN EORTC 18952/EORTC IIB/III-N1: IFN/PEG-IFN IIB/III-N1: Observation Stage III-N2: HR 1.01 (99% CI: 0.80, 1.27) III-N2: IFN/PEG-IFN III-N2: Observation Stage IIB/III-N1: HR 0.81 (99% CI: 0.61, 1.09) Years O N Number of patients at risk Eggermont AM, et al. Eur J Cancer. 2012;48: Patients Alive (%) III-N1: Ipilimumab III-N1: Placebo Ipilimumab EORTC Stage III-N2: HR 0.80 (99% CI: 0.58, 1.11) III-N2: Ipilimumab III-N2: Placebo Stage III-N1: HR 0.61 (99% CI: 0.39, 0.96) Years O N Number of patients at risk
77 Summary/Conclusions Efficacy of ipilimumab 10 mg/kg vs placebo o Prolonged OS, DMFS, and RFS 28% risk reduction of death; 24% risk reduction for both DMFS and RFS o Increased 5-year rates OS: 65% vs 54%; DMFS: 48% vs 39%; RFS: 41% vs 30% Safety results demonstrate a significant immune-related AE rate Currently, adjuvant ipilimumab represents an important treatment option for patients with high-risk stage III melanoma
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