largos supervivientes, ¿tenemos datos? · rosenberg j, et al. lancet 2016 os data from...
TRANSCRIPT
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Largos Supervivientes,
¿Tenemos datos? Javier Puente, MD, PhD
Medical Oncology Department. Hospital Clinico San Carlos
Associate Professor of Medicine. Complutense University of Madrid.
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Summary
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Cancer Care 20 years ago
Snapshot
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Cancer Genomics
Advent of the “precision medicine” era
But cancer´s biology is far more complex than we had imagined
Schilsky R. ASCO 2016
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Rise of Immunotherapy
Game-changing discoveries-more coming
Schilsky R. ASCO 2016
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Mortality down, Survivorship Up
Since the 1990s:
In the United States…
DeSantis C, et al. CA A Cancer Journal for Clinicians 2014
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Take into account…
Long-survivals
LONG
SURVIVAL
? Enough Follow-up
Perspective
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4 examples with Immunotherapy
Long-survivals
1. Non-small cell lung cancer
2. Urothelial carcinoma
3. Renal cancer
4. Melanoma
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4 examples with Immunotherapy
Long-survivals
1. Non-small cell lung cancer
2. Urothelial carcinoma
3. Renal cancer
4. Melanoma
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Lung Cancer Outcome: 8th TNM
NSCLC
Estadio I 24%
Estadio II 7%
Estadio III
31%
Estadio IV
38%
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Lung Cancer Outcome: first data
NSCLC
CA209-003 Study: 3 yrs OS
3y OS- 18%
3y OS- 19%
3y OS- 29% in PDL1 >50%
KeyNote-001 : 3 yrs OS
Gettinger et al. JCO 2014; Leighl ASCO 2017
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Lung Cancer Outcome: first data
NSCLC
CA209-003 Study: 5 yrs OS
Brahmer, et al. AACR-2017
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Lung Cancer Outcome: first data
NSCLC
CA209-003 Study: 5 yrs OS
Brahmer, et al. AACR-2017
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Lung Cancer Outcome: first data
NSCLC
CA209-003 Study: 5 yrs OS
Brahmer, et al. AACR-2017
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Classic results with chemo
NSCLC
Reck et al Lancet Oncol 2014; Garon et al. Lancet Oncol 2014
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Immunotherapy in pretreated patients
NSCLC
Borghaei H, et al. ASCO 2016; Brahmer et al. AACR 2017; Herbst RS, et al. ASCO 2017; Rittmeyer A, et al. Lancet 2017
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Nivolumab 2L: 3 year survival rate
NSCLC
Borghaei H, et al. ASCO 2016; Brahmer et al. AACR 2017; Herbst RS, et al. ASCO 2017; Rittmeyer A, et al. Lancet 2017
CI = confidence interval; HR = hazard ratio
135 86 57 38 31 26 21 16 8 0
137 69 33 17 11 10 8 7 3 0
CheckMate 017 (SQ NSCLC)
No. of patients at risk
Nivolumab
Docetaxel
0 6 12 18 24 30 36 42 48 54
Δ10%
Nivolumab (n = 135)
Docetaxel (n = 137)
1-y OS = 42%
2-y OS = 23%
3-y OS = 16% 1-y OS = 24%
2-y OS = 8% 3-y OS = 6%
HR (95% CI): 0.62 (0.48, 0.80)
100
80
60
40
20
0
OS
(%)
Months
Δ18%
Δ15%
292 194 148 112 82 58 49 39 7 0
290 195 112 67 46 35 26 16 1 0
CheckMate 057 (non-SQ NSCLC)
No. of patients at risk
Nivolumab
Docetaxel
0 6 12 18 24 30 36 42 48 54
Months
1-y OS = 51%
2-y OS = 29%
3-y OS = 18%
1-y OS = 39%
2-y OS = 16% 3-y OS = 9%
Nivolumab (n = 292)
Docetaxel (n = 290)
HR (95% CI): 0.73 (0.62, 0.88)
100
80
60
40
20
0
OS
(%)
Δ12%
Δ13%
Δ9%
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Nivolumab 2L: 3 year survival rate
NSCLC
Felip E, et al. ESMO 2017
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Nivolumab 2L: 3 year survival rate
NSCLC
Felip E, et al. ESMO 2017
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Nivolumab 2L: 3 year survival rate and by PD-L1 expression
NSCLC
Felip E, et al. ESMO 2017
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Pembrolizumab 2L
NSCLC
Keynote 010: 30-months OS (all population)
Herbst at al. ASCO 2017
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Atezolizumab 2L
NSCLC
OAK: OS ITT population at 2 years
Satouchi et al. WLCC 2017
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Long survivors 1st line phase I
NSCLC
Eberhardt et al. JTO 2015; Leighl et al. ASCO 2017
8th TNM IASLC Classification, 3-y OS M1c: ~8%
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Long survivors 1st line phase I
NSCLC
Reck, et al. NEJM 2016
Keynote 024, Pembrolizumab in PD-L1 positive patients
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Long survivors 1st line phase I
NSCLC
Reck, et al. NEJM 2016
Keynote 024, Pembrolizumab in PD-L1 positive patients
2 ys OS 51.5% vs 34.5%
HR 0.63 62.3% Crossover
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Long survivors 1st line phase I
NSCLC
WLCC 2017
CheckMate 012: Nivolumab plus ipilimumab
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Long survivors 1st line
NSCLC
Keynote-021
Borghaei, et al. WLCC 2017
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Long survivors 1st line
NSCLC
Keynote-021
Median (95% CI)
19.0 (8.5–NR)
8.9 (6.2–11.8)
57%
37%
52%
29%
Events,
n/N HR (95% CI)
Pembro + PC 26/60 0.54
(0.33–0.88)
P = 0.0067a PC alone 40/63
0
25
50
75
100
Pembrolizumab+ PC
PCAlone
OR
R, %
(9
5%
CI)
Δ24.8%
(95% CI, 7.2%‒40.9%)
P = 0.0029a
Borghaei, et al. WLCC 2017
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Long survivors 1st line
NSCLC
Borghaei, et al. WLCC 2017
Keynote-021
77%
69% 70%
56%
Median (95% CI)
NR (22.8–NR)
20.9 (14.9–NR) Crossover ~ 75%
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4 examples with Immunotherapy
Long-survivals
1. Non-small cell lung cancer
2. Urothelial carcinoma
3. Renal cancer
4. Melanoma
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Percent of cases & 5-year relative survival
Urothelial carcinoma
Slide from E. Grande. Best of GU 2015
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Cancer Care 20 years ago
Snapshot
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Overall survival
Urothelial carcinoma
‘Fit’ for Cisplatin Cisplatin ineligible (unfit)
Median OS 8.1m 9.3m
von der Maase, et al. J Clin Oncol 2005
De Santis, et al. J Clin Oncol 2012
Galsky, et al. Lancet Oncol 2011
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Overall survival
Urothelial carcinoma
Pal S, et al. Plos One 2015
Role of taxanes in the 2nd line
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Overall survival
Urothelial carcinoma
Bellmunt J, et al. J Clin Oncol 2009
Role of vinflunine in the 2nd line
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Keynote-045: pembrolizumab as second-line
Pembrolizumab
200 mg Q3W
(N = 270)
Investigator’s Choice
Paclitaxel 175 mg/m2 Q3W or
Docetaxel 75 mg/m2 Q3W or
Vinflunine 320 mg/m2 Q3W
(N = 272)
Treated up to 24 mos or
until CR, PD,
unacceptable AE, or
investigator decision*†
Treated until PD,
unacceptable AE, or
patient withdrawal of
consent
▪ Primary endpoints: OS, PFS in overall and in PD-L1 CPS ≥ 10% populations
▪ Secondary endpoints: ORR, DoR in overall and in PD-L1 CPS ≥ 10% populations; safety
Patients with metastatic or locally
advanced UC after recurrence or
progression following platinum-based
chemotherapy;
ECOG PS ≤ 2; evaluable tumor tissue
for PD-L1 testing
(N = 542)
Bellmunt J, et al. NEJM 2017
Urothelial carcinoma
Long survivors 2nd line
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Bellmunt J, et al. NEJM 2017
Urothelial carcinoma
Long survivors 2nd line
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Petrylak, et al. ESMO 2017
Urothelial carcinoma
Long survivors 2nd line
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Rosenberg J, et al. Lancet 2016
Response Rate - primary endpoint
Urothelial carcinoma
Long survivors 2nd line
Atezolizumab in mUC: IMvigor 210
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Rosenberg J, et al. Lancet 2016
OS data from Atezolizumab in UBC
Urothelial carcinoma
Long survivors 2nd line
Atezolizumab in mUC: IMvigor 210
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Balar A, et al. Lancet 2017
Urothelial carcinoma
Long survivors 1st line
Atezolizumab in mUC: IMvigor 210
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Atezolizumab in mUC: IMvigor 210
Rosenberg J, et al. Lancet 2016
Urothelial carcinoma
Long survivors 2nd line
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Nivolumab: phase II Check-Mate 275
Urothelial carcinoma
Long survivors 2nd line
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4 examples with Immunotherapy
Long-survivals
1. Non-small cell lung cancer
2. Urothelial carcinoma
3. Renal cancer
4. Melanoma
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Overall survival
Kidney cancer
Surgical “classic data”
Topalian et al. SITC 2017
MSKCC “classic data”
0.0
0.2
0.4
0.6
0.8
1.0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
Years following systemic therapy
Pro
po
rtio
n s
urv
ivin
g
7 months
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Overall survival
Kidney cancer
CheckMate 003
Topalian et al. SITC 2017
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Overall survival
Kidney cancer
CheckMate 025
Sharma P, et al. KCA 2017
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Overall survival
Kidney Cancer
Hammers et al. ESMO 2016
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Overall survival
Kidney Cancer
Hammers et al. ESMO 2016
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4 examples with Immunotherapy
Long-survivals
1. Non-small cell lung cancer
2. Urothelial carcinoma
3. Renal cancer
4. Melanoma
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Overall survival
Melanoma
Historical controls
Middleton MR, et al JCO 2000
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Overall survival
Melanoma
Ipilimumab Pool analysis
Schadendorf et al. JCO 2015
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Overall survival
Melanoma
Hodi et al. AACR 2016; Robert et al. ASCO 2016
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Overall survival
Melanoma
CheckMate 063: Nivolumab vs Dacarbazine
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Overall survival
Melanoma
Keynote 006: Pembrolizumab
Robert et al. NEJM 2015; Schachter et al. SMR 2015
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Overall survival
Melanoma
CheckMate 069/067: Pooled 3-year analysis
Postow et al. SITC 2017
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Expectations
Long-survivals
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Overall survival
Melanoma
LONG TERM SURVIVAL
Schadendorf et al. JCO 2015