CLOC2020: Terapia adyuvante de melanoma

Tratamiento Adyuvante de Melanoma
- Indicaciones y Alternativas -
Mauricio Lema Medina MD
Clínica de Oncología Astorga / Clínica SOMA
Medellín, Colombia

Mauricio Lema Medina MD
Clínica de Oncología Astorga / Clínica SOMA
Medellín
Inspirado en: Michael Bierut, 2013, Logo para Mohawk Fine Papers

Presenter disclosures
Clinical Trials
Merck-Sharp & Dohme, ROCHE
Research Grant Support
BMS, Pfizer
Consultancy
Boehringer Ingelheim, Aztra-Zeneca, Bristol-Myers Squibb, Pfizer, Merck-Sharp & Dohme

High-Risk Surgically Resected Melanoma
Gershenwald. CA Cancer J Clin. 2017;67:472. Slide credit: clinicaloptions.com
KM Melanoma-Specific Survival Curves According to T Category
Stage Group for Patients With Stage I and II Melanoma
KM Melanoma-Specific Survival Curves
According to Stage III Subgroups
 Adjuvant therapy provides an opportunity to cure
IIIA
IIIB
IIIC
IIID
N
1006
1170
2201
205
5 Yrs
93%
83%
69%
32%
10 Yrs
88%
77%
60%
24%
1.0
0.8
0.6
0.4
0.2
0
Melanoma-SpecificSurvivalProbability
Yrs Since Diagnosis
0 2 4 6 8 10
1.0
0.8
0.6
0.4
0.2
0
Melanoma-SpecificSurvivalProbability
Yrs Since Diagnosis
0 2 4 6 8 10
IA
IB
IIA
IIB
IIC
N
5225
5749
2338
1688
691
5 Yrs
99%
97%
94%
87%
82%
10 Yrs
98%
94%
88%
82%
75%

Occult LN
metastasis (ie,
findings in the
SNB)

≥4 LN +/- In-transit
metástasis +/-
Microsatellite

Key Trials Leading to US Regulatory Approval for IFN
and Ipilimumab
1. Kirkwood. JCO. 1996;14:7. 2. Kirkwood. Clin Cancer Res. 2004;10:1670. 3. Kirkwood. JCO. 2000;18:2444. 4. Kirkwood. JCO.
2001;19:2370. 5. Eggermont. Lancet. 2008;372:117. 6. Eggermont. JCO. 2012;30:3810. 7. Eggermont. NEJM. 2016;375:1845. Slide credit: clinicaloptions.com
Study Stage N Regimen
Median Follow-up,
Yrs
Impact on
RFS (HR) OS (HR)
E1684[1,2] T4, N+ 287 HD-IFN vs observation
6.9 0.61 0.67
12.6 0.72 0.82*
E1690[2,3] T4, N+ 642 HD-IFN or LD-IFN vs observation
4.3 0.78 --
6.6 0.81 --
E1694[2,4] T4, N+ 880 HD-IFN vs GMK vaccine
1.3 0.68 0.66
2.1 0.75 0.76
EORTC
18991[5,6] N1,2 1256 Pegylated IFN vs observation
3.8 0.82 --
7.6 0.87 --
EORTC
18071[7] N1,2,3 951 Ipilimumab 10 mg/kg vs placebo 5.3 0.76 0.72
*P = .18

Cochrane Analysis of Adjuvant IFN for High-Risk
Melanoma
Mocellin. Cochrane Database Syst Rev. 2013:CD008955. Slide credit: clinicaloptions.com
Parameter RFS OS
Studies analyzed, n 17 15
Patients analyzed, n 10,345 9,927
HR (95% CI) 0.83 (0.78-0.87) 0.91 (0.85-0.97)
Relative risk reduction, % 17 9
NNT, n -- 35

Adjuvant Ipilimumab in Melanoma

EORTC 18071: Phase III Trial of Ipilimumab 10 mg/kg vs
Placebo in Stage III Melanoma
 Randomized, double-blind phase III trial of ipilimumab 10 mg/kg vs placebo as
adjuvant therapy for stage III melanoma after surgical resection (N = 951)
Eggermont. NEJM. 2016;375:1845. Slide credit: clinicaloptions.com
Yr
0
10
20
30
40
50
60
70
80
90
100
0 1 2 3 54 6 7 8
PatientsAliveandWithout
Recurrence(%)
HR for recurrence or death: 0.76
(95% CI: 0.64-0.89; P < .001)
Ipilimumab
Placebo
Median RFS, Mos
(95% CI)
5-Yr Rate, %
(95% CI)
Ipilimumab 27.6 (19.3-37.2) 40.8 (36.0-45.6)
Placebo 17.1 (13.6-21.6) 30.3 (26.0-34.6)
RFS
Yr
0
10
20
30
40
50
60
70
80
90
100
0 1 2 3 54 6 7 8
PatientsAlive(%)
HR for death: 0.72
(95.1% CI: 0.58-0.88; P = .001)
Ipilimumab
Placebo
5-Yr Rate, %
(95% CI)
Ipilimumab 65.4 (60.8-69.6)
Placebo 54.4 (49.7-58.9)
OS

EORTC 18071: Safety
 Deaths due to treatment-related AEs
‒ 5 patients (1.1%) in ipilimumab arm (3 colitis, 1 myocarditis, 1 multiorgan failure with
Guillain-Barre syndrome)
Eggermont. NEJM. 2016;375:1845. Eggermont. ESMO 2016. Abstr LBA2_PR. Slide credit: clinicaloptions.com
AEs, %
Ipilimumab
(n = 471)
Any Grade Grade 3/4
Any AE 98.7 54.1
Treatment-related AE 94.1 45.4
Treatment-related AE leading to d/c 48.0 32.9
Any immune-related AE 90.4 41.6

HR: 1.0 (95% CI: 0.81- 1.24)
Yrs
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
0 1 2 3 54
Probability
 Randomized, double-blind phase III trial of ipilimumab 3 mg/kg or 10 mg/kg vs
HD IFN for patients with resected stage IIIB, IIIC, or IV melanoma (N = 1673)
E1609: Ipilimumab 3 mg/kg or 10 mg/kg vs High-Dose
IFN for High-Risk Resected Melanoma
Tarhini. ASCO 2017. Abstr 9500. Slide credit: clinicaloptions.com
AEs, %
Ipi 3 mg/kg
(n = 516)
Ipi 10 mg/kg
(n = 503)
Any
Grade
Grade
3/4
Any
Grade
Grade
3/4
Any 98.4 53.3 100 65.4
TRAE 96.0 36.6 98.8 56.5
TRAE
leading to
d/c
34.9 25.0 53.7 42.9
Any irAE 73.6 18.8 86.9 34.0
RFS
10 mg lpi (n = 406)
3 mg lpi (n = 367)

Inspirado en: Saul Bass, 1955,, The Man With the Golden Arm

PD1 inhibitors in the adjuvant setting

CheckMate 238: Adjuvant Nivolumab vs Ipilimumab in
High-Risk Melanoma
 Randomized, double-blind phase III trial
 Coprimary endpoints: RFS in ITT population
 Secondary endpoints: OS, safety, RFS by PD-L1 status, QoL
 Exploratory endpoint: DMFS
Patients with
resected high-risk
stage IIIB, IIIC, or IV
melanoma
(N = 906)
Nivolumab
3 mg/kg IV Q2W + Placebo
(n = 453)
Ipilimumab
10 mg/kg IV Q3W + Placebo
(n = 453)
Treatment up to 1 yr
Weber. NEJM. 2017;377:1824. Slide credit: clinicaloptions.com

CheckMate 238: Relapse-Free Survival
 Minimum follow-up: 18 mos (median: 19.5)
Median RFS not reached in either arm
100
90
80
70
60
50
40
30
20
10
0
270 3 6 9 12 15 18 21 24
Mos
RFS,ITTPopulation(%)
HR: 0.65 (97.56% CI: 0.51-0.83; P < .001)
Nivolumab: 154 events/453 patients
Ipilimumab: 206 events/453 patients

CheckMate 238: RFS by PD-L1 Expression
RFS in Patients With PD-L1 Expression < 5% RFS in Patients With PD-L1 Expression ≥ 5%
HR: 0.71
(95% CI: 0.56-0.91)
64.3%
53.7%
Nivolumab:
114 events/275 patients
Ipilimumab:
143 events/286 patients HR: 0.50
(95% CI: 0.32-0.78)
81.9%
73.8%
Ipilimumab:
RFS(%)
Mos
0 3 6 9 12 15 18 21 24 27
0
10
20
30
40
50
60
70
80
90
100
RFS(%)
Mos
0 3 6 9 12 15 18 21 24 27
0
10
20
30
40
50
60
70
80
90
100

CheckMate 238: RFS by BRAF Status
Weber. ESMO 2017. Abstr LBA8_PR. Slide credit: clinicaloptions.com
HR: 0.72
(95% CI: 0.52-1.00)
Nivolumab:
Ipilimumab:
68%
63%
HR: 0.58
(95% CI: 0.43-0.79)
Ipilimumab:
72%
57%
RFS(%)
Mos
0 3 6 9 12 15 18 21 24 27
0
10
20
30
40
50
60
70
80
90
100
RFS(%)
Mos
0 3 6 9 12 15 18 21 24 27
0
10
20
30
40
50
60
70
80
90
100
RFS When BRAF Mutated RFS When BRAF Wildtype

CheckMate 238: RFS in Prespecified Groups
Subgroup
Events/Patients Unstratified
HR (95% CI)
Unstratified HR
(95% CI)Nivo 3 mg/kg Ipi 10 mg/kg
Overall Overall 154/453 206/453 0.66 (0.53-0.81)
Age < 65 yrs 106/333 147/339 0.65 (0.51-0.84)
≥ 65 yrs 48/120 59/114 0.66 (0.45-0.97)
Sex Male 99/258 133/269 0.68 (0.53-0.88)
Female 55/195 73/184 0.63 (0.44-0.89)
Stage IIIB 41/163 54/148 0.67 (0.44-1.00)
IIIC 79/204 109/218 0.65 (0.49-0.87)
IV M1a-M1b 25/62 35/66 0.63 (0.38-1.05)
IV M1c 8/20 8/21 1.00 (0.37-2.66)
Not reported 1/2 0/0
Ulceration in stage III Absent 58/201 94/216 0.59 (0.42-0.82)
Present 60/153 64/135 0.73 (0.51-1.04)
Not reported 2/15 5/15 0.39 (0.07-2.00)
Lymph node involvement
in stage III
Microscopic 41/125 55/134 0.71 (0.47-1.07)
Macroscopic 72/219 101/214 0.62 (0.46-0.84)
Not reported 7/25 7/18 0.60 (0.21-1.72)
PD-L1 status < 5%/indeterminate 123/300 149/299 0.71 (0.56-0.90)
≥ 5% 31/152 57/154 0.50 (0.32-0.78)
BRAF status Mutation 63/187 84/194 0.72 (0.52-1.00)
No mutation 67/197 105/214 0.58 (0.43-0.79)
Not reported 24/69 17/45 0.83 (0.45-1.54)
Nivolumab Ipilimumab
0 1 2

KEYNOTE-054: Adjuvant Pembrolizumab vs Placebo for
Stage III Melanoma
 Randomized, double-blind phase III study
 Coprimary endpoints: RFS in ITT population, RFS in PD-L1+ subgroup
 Secondary endpoints: DMFS, OS, safety, QoL
Slide credit: clinicaloptions.comEggermont. NEJM. 2018;378:1789.
Patients with resected
high-risk stage IIIA, B, C
melanoma
(N = 1019)
Pembrolizumab
200 mg IV Q3W*
(n = 514)
Placebo
IV Q3W*
(n = 505)
*Patients with recurrence eligible for crossover
or repeat treatment with pembrolizumab.
Treatment administered 18 doses
(~ 1 yr) or until recurrence,
unacceptable toxicity, or withdrawal

KEYNOTE-054: Relapse-Free Survival
 Median follow-up: 15.1 mos
P < .001
100
90
80
70
60
50
40
30
20
10
0
0 3 6 9 12 15 18 21 24
Mos
RFS,ITTPopulation(%)
Pembrolizumab
Placebo
Pembrolizumab
Placebo
HR (98.4% CI)
0.57 (0.43-0.74)
1.00
1-yr RFS: pembrolizumab, 75.4%; placebo, 61.0%

KEYNOTE-054: RFS by PD-L1 Status
RFS in Patients With
PD-L1–Positive Tumors
RFS in Patients With
PD-L1–Negative Tumors
Mos
PatientsAliveand
RecurrenceFree(%)
100
0
10
20
30
40
50
60
70
80
90
0 2418 21156 9 123
Pembrolizumab
Placebo
HR (95% CI)
0.54 (0.42-0.69)
1.00
1-Yr RFS (%)
77.1
62.6
Total/
Event
428/102
425/176
P < .001
Pembrolizumab
Placebo
HR (95% CI)
0.47 (0.26-0.85)
1.00
1-Yr RFS (%)
72.2
52.2
Total/
Event
59/20
57/27
P = .01
Mos
PatientsAliveand
RecurrenceFree(%)
100
0
10
20
30
40
50
60
70
80
90
0 2418 21156 9 123
Pembrolizumab
Pembrolizumab
Placebo
Placebo

Mos
PatientsAliveandRecurrenceFree(%)
100
0
10
20
30
40
50
60
70
80
90
0 2418 21156 9 123
KEYNOTE-054: RFS in Stage IIIA Population
Slide credit: clinicaloptions.comEggermont. AACR 2018. Abstr CT001.
Pembrolizumab
Placebo
Total Event HR (99% CI)
77 6 0.32 (0.09-1.23)
76 15 Reference
P = .0217
93.4% 89.8%
81.1%
76.8%

KEYNOTE-054: RFS in Stage IIIB and IIIC Populations
Slide credit: clinicaloptions.comEggermont. AACR 2018. Abstr CT001.
RFS in Patients With Stage IIIB Disease RFS in Patients With Stage IIIC Disease
Mos
PatientsAliveand
RecurrenceFree(%)
100
0
10
20
30
40
50
60
70
80
90
0 2418 21156 9 123
75.8% 71.4%
62.4%
54.8%
Mos
PatientsAliveand
RecurrenceFree(%)
100
0
10
20
30
40
50
60
70
80
90
0 2418 21156 9 123
67.7% 64.3%
51.5%
42.5%
Pembrolizumab
Placebo
240 62 0.56 (0.37-0.86)
232 97 Reference
P = .0004 Pembrolizumab
Placebo
197 67 0.58 (0.39-0.88)
197 104 Reference
P = .0005
Pembrolizumab
Placebo
Pembrolizumab
Placebo

KEYNOTE-054: RFS by BRAF Mutation Status
RFS in Patients With BRAF V600E/K Mutation RFS in Patients With BRAF WT
Mos
PatientsAliveand
RecurrenceFree(%)
100
0
10
20
30
40
50
60
70
80
90
0 2418 21156 9 123
72.5% 69.2%
58.6%
52.4%
Mos
PatientsAliveand
RecurrenceFree(%)
100
0
10
20
30
40
50
60
70
80
90
0 2418 21156 9 123
73.0%
66.7%
59.7%
48.8%
Pembrolizumab
Placebo
186 54 0.57 (0.37-0.89)
209 94 Reference
P = .0009 Pembrolizumab
Placebo
233 69 0.64 (0.42-0.96)
214 97 Reference
P = .0039
Pembrolizumab
Placebo
Pembrolizumab
Placebo

KEYNOTE-054: RFS in Prespecified Groups
Subgroup
No. of Events/Total No.
HR (99% or 98.4% CI)
P Value for
InteractionPembrolizumab Placebo
Tumor PD-L1 expression
Positive
Negative
Indeterminate
102/428
20/59
13/27
176/425
27/57
13/23
0.54 (0.39-0.74)
0.60 (0.28-1.28)
0.80 (0.29-2.19)
.60
AJCC 2009 classification
Stage IIIA
Stage IIIB
Stage IIIC
6/77
62/240
67/197
15/76
97/232
104/197
0.38 (0.11-1.31)
0.58 (0.38-0.88)
0.58 (0.38-0.86)
.69
Type of positive lymph nodes
Microscopic
Macroscopic
35/187
100/327
50/161
166/344
0.56 (0.32-0.99)
0.59 (0.42-0.81)
.86
BRAF mutation status
Wild type
V600E mutation
69/233
54/186
97/214
94/209
0.61 (0.41-0.92)
0.59 (0.38-0.92)
.89
All patients 135/514
(26.6%)
216/505
(42.8%)
0.57 (0.43-0.74)
0.25 0.50 1.00 2.00 4.00
Pembrolizumab Better Placebo Better

*Prespecified significance boundary (P=0.000019).
Select AEs in CheckMate 238 and KEYNOTE-054
Slide credit: clinicaloptions.comLong. NEJM. 2017;377:1813.
CheckMate 238
AEs, % Nivolumab
(n = 452)
Ipilimumab
(n = 453)
Any
Grade
Grade
3/4
Any
Grade
Grade
3/4
Any AE 96.9 25.4 98.5 55.2
TRAE*
 Fatigue
 Diarrhea
 Pruritus
 Rash
 Nausea
 Arthralgia
 Asthenia
 Hypothyroidism
85.2
34.5
24.3
23.2
19.9
15.0
12.6
12.6
10.8
14.4
0.4
1.5
0
1.1
0.2
0.2
0.2
0.2
95.8
32.9
45.9
33.6
29.4
20.1
10.8
11.7
6.8
45.9
0.9
9.5
1.1
3.1
0
0.4
0.9
0.4
TRAE leading to d/c 7.7 3.5 41.7 30.0
KEYNOTE-054
AEs, %
Pembrolizumab
(n = 509)
Placebo
(n = 502)
Any
Grade
Grade
≥ 3
Any
Grade
Grade
≥ 3
Any AE 93.3 31.6 90.2 18.5
TRAE*
 Fatigue or asthenia
 Rash
 Pruritus
 Diarrhea
 Arthralgia
 Nausea
 Hypothyroidism
 Hyperthyroidism
77.8
37.1
16.1
17.7
19.1
12.0
11.4
14.3
10.2
14.7
0.8
0.2
0
0.8
0.6
0
0
0.2
66.1
33.3
10.8
10.2
16.7
11.0
8.6
2.8
1.2
3.4
0.4
0
0
0.6
0
0
0
0
TRAE leading to d/c 13.0 NR 1.6 NR
*Occurring in ≥ 10% of patients in the experimental arm.

Adjuvant Therapy Options for Patients
with Mutated BRAF

RTK
Ras
BRAF
MEK
ERK
Transcription
Cell membrane
Nuclear membrane
DNA
Proliferation
Survival

RTK
Ras
V600 BRAF mutation
MEK
ERK
Transcription
Cell membrane
Nuclear membrane
DNA
↑Proliferation
↑Survival

MEK
ERK
Transcription
Nuclear membrane
DNA
↑Proliferation
↑Survival
V600 BRAF mutation

MEK
ERK
Transcription
Nuclear membrane
DNA
↑Proliferation
↑Survival
V600 BRAF mutation
Anti-
BRAF
RTK
Ras
Cell membrane

MEK
ERK
Transcription
Nuclear membrane
DNA
↓Proliferation
↓Survival
V600 BRAF mutation
RTK
Ras
Cell membrane
Dabrafenib
Vemurafenib
Encorafenib
Anti-
BRAF

mMEK
ERK
Transcription
Nuclear membrane
DNA
V600 BRAF mutation
↑RTK
↑Ras
Cell membrane
Dabrafenib
Vemurafenib
Encorafenib
Anti BRAF
resistance
Mechanisms
↑cRAF
↓Proliferation
↓Survival
↑COT
Anti-
BRAF

mMEK
ERK
Transcription
Nuclear membrane
DNA
V600 BRAF mutation
↑RTK
↑Ras
Cell membrane
Dabrafenib
Vemurafenib
Encorafenib
Anti BRAF
resistance
Mechanisms
↑cRAF
↑Proliferation
↑Survival
↑COT
Anti-
BRAF

MEK
ERK
Transcription
Nuclear membrane
DNA
↓Proliferation
↓Survival
V600 BRAF mutation
RTK
Ras
Cell membrane
Dabrafenib
Vemurafenib
Encorafenib
Anti
MEK Trametinib
Cobimetinib
Binimetinib
Dual, BRAF and
MEK, blockade
Anti-
BRAF

*Patients were followed for disease recurrence until the first recurrence and thereafter for survival. †The study will be
considered complete and final OS analysis will occur when ~70% of randomized patients have died or are lost to follow-up.
‡New primary melanoma considered as an event.
COMBI-AD: Adjuvant Dabrafenib + Trametinib for
Stage III Melanoma With BRAF V600 Mutation
 Randomized, double-blind phase III study
 Coprimary endpoints: RFS
 Secondary endpoints: OS, DMFS, FFR, safety
Patients with completely
resected stage III melanoma
with BRAF V600E/K
mutation; ECOG PS 0/1; no
prior radiotherapy or
systemic therapy
(N = 870)
Dabrafenib 150 mg PO BD +
Trametinib 2 mg PO QD
(n = 438)
Placebo
(n = 432)
Patients treated for
12 mos or until
recurrence,
unacceptable toxicity,
withdrawal, or death

88%
67%
56%
44%
39%
58%
COMBI-AD: Relapse-Free Survival
 Median follow-up: 2.8 yrs
1.0
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
Mos
PatientsAliveand
RecurrenceFree(%)
0 22 2414 18 20166 10 1282 4 34 3626 30 3228 46 4838 42 4440 5250
D + T
Placebo
Total
438
432
Event
166
248
HR (95% CI)
0.47 (0.39-0.58)
1.00
P < .001
Dabrafenib + trametinib
Placebo

COMBI-AD: Distant Metastasis–Free Survival
1.0
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
Mos
PatientsAliveand
DistantMetastasisFree(%)
0 22 2414 18 20166 10 1282 4 34 3626 30 3228 46 4838 42 4440 5250
P < .001
D + T
Placebo
Total
438
432
Event
110
152
HR (95% CI)
0.51 (0.40-0.65)
1.00
Placebo

COMBI-AD: RFS in Prespecified Subgroups
Events/Patients, n/N
Subgroup D + T Placebo
BRAF V600K 16/41 19/37
BRAF V600E 150/397 229/395
Male 92/243 144/239
Female 73/195 104/193
Age < 65 yrs 135/353 201/359
Age ≥ 65 yrs 31/85 47/73
Disease stage IIIA 15/83 23/71
Disease stage IIIB 64/169 110/187
Disease stage IIIC 84/181 111/166
Micrometastasis 39/152 72/157
Macrometastasis 61/158 101/161
Micrometastasis and ulceration 24/64 47/79
Micrometastasis and no ulceration 15/87 25/78
Macrometastasis and ulceration 23/58 42/58
Macrometastasis and no ulceration 38/100 57/101
1 nodal metastatic mass 58/177 93/183
2-3 nodal metastatic masses 57/158 94/150
≥ 4 nodal metastatic masses 40/73 50/72
Favors D + T Favors Placebo
0.51
0.37
0.52
0.51
0.33
0.43
0.49
0.43
0.44
0.45
0.50
0.44
0.38
0.51
0.55
0.43
0.48
0.54
HR
0.01 1.00 10.000.10

COMBI-AD: OS at First Interim Analysis
97%
91%
86%
94%
83%
77%
P = .0006
1.0
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
Mos
PatientsAlive(%)
0 22 2414 18 20166 10 1282 4 34 3626 30 3228 46 4838 42 4440 52 5450
D + T
Placebo
Total
438
432
Event
60
93
HR (95% CI)
0.57 (0.42-0.79)
1.00
Placebo

COMBI-AD: Safety Summary
AEs, %
Dabrafenib + Trametinib
(n = 435)
Placebo
(n = 432)
Any Grade Grade 3/4 Any Grade Grade 3/4
Any AE
 Pyrexia
 Fatigue
 Nausea
 Headache
 Chills
 Diarrhea
97
63
47
40
39
37
33
41
5
4
1
1
1
1
88
11
28
20
24
4
15
14
< 1
< 1
0
0
0
< 1
AEs leading to dose interruption 66 NA 15 NA
AEs leading to dose reduction 38 NA 3 NA
AEs leading to d/c of study regimen 26 NA 3 NA

Hauschild A, JCO, 2018
Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in
Patients With Resected BRAF V600–Mutant Stage III Melanoma - COMBI-AD Trial
Weibull mixture cure-rate model

Resected stage III or
IV melanoma
Stage
IV
Nivo
Stage III
Nivo
BRAFwt
Pembro
mBRAF
Nivo PembroDabr/Tram
Stage IIIB-D

Resected stage III or
IV melanoma
Stage
IV
Nivo
Stage III
Nivo
BRAFwt
Pembro
mBRAF
Nivo PembroDabr/Tram
Stage IIIB-D
Pembrolizumab not
approved for adjuvant
therapy in Colombia

Conclusions
• For stage III or resected stage IV
• Adjuvant (wtBRAF)
• Nivolumab or Pembrolizumab for HR Stage III
• Nivolumab for R0 resected Stage IV
• Adjuvant Mutated BRAF
• May consider Dabrafenib + Trametinib

CLOC2020: Terapia adyuvante de melanoma

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CLOC2020: Terapia adyuvante de melanoma