I tumori del rene: Trattamento di I linea Novità diagnostico terapeutiche nel carcinoma renale e prostatico Campobasso, 19 Settembre 2019 Enrico Ricevuto & Gemma Bruera Assistenza Oncologica Territoriale Ospedale S. Salvatore L’Aquila Rete Oncologica ASL1 Abruzzo Dipartimento Scienze Cliniche Applicate e Biotecnologiche Università dell’Aquila
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I tumori del rene: Trattamento di I linea - AIOM...Cytoreductive nephrectomy, Metastasectomy and post-operative treatment Active surveillance Medical Treatments: Perspectives VEGFR-TKI/Immunotherapy
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I tumori del rene:
Trattamento di I linea
Novità diagnostico terapeutiche nel carcinoma renale e prostatico
Campobasso, 19 Settembre 2019
Enrico Ricevuto & Gemma Bruera
Assistenza Oncologica Territoriale
Ospedale S. Salvatore L’Aquila
Rete Oncologica ASL1 Abruzzo
Dipartimento Scienze Cliniche Applicate e Biotecnologiche
Università dell’Aquila
2 2
mRCC: I Line Treatment Options
Medical Treatments
VEGFR-TKI: Sunitinib, Pazopanib, Tivozanib
Immunotherapy: Nivolumab/Ipilimumab
MET-Inhibitors: Cabozantinib
Cytoreductive nephrectomy, Metastasectomy and post-operative
treatment
Active surveillance
Medical Treatments: Perspectives
VEGFR-TKI/Immunotherapy Associations:
Pembrolizumab/Axitinib
Atezolizumab/Bevacizumab
Avelumab/Sunitinib
3
A retrospective study utilizing 2000–2010 SEER data evaluated changes in survival
between pre-targeted therapy and targeted therapy periods in advanced RCC
Patients in the targeted therapy era showed improved survival compared with those
diagnosed in the pretarget therapy era (HR, 0.86, P<0.01)
Overall Survival in the Pre-targeted Therapy vs Targeted Therapy Eras
HR, hazard ratio; RCC, renal cell carcinoma; SEER, Surveillance, Epidemiology, and End Results.
Li P et al. Cancer Med 2016;5:169–81.
Pretarget Era (2000–2005): N=7,231
Targeted Era (2006–2010): N=6,439
Years
0
0.25
0.50
0.75
1.00
1 2 3 4 5 6
Overall Survival, Advanced RCC
Ove
rall
Su
rviv
al
(Pro
ba
bil
ity)
4
5
6
7
8
9
Lee et al, Ann Onc 2015
Bracarda et al, Ann Onc 2016
10
11
mRCC: I Line treatment IMDC risk Prognostic Score
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14
mRCC: I Line treatment Checkmate 214
15
mRCC: I Line treatment Checkmate 214, Baseline Characteristics
17
mRCC I Line treatment Checkmate 214: IMDC Intermediate/Poor, OR/DOR
18
mRCC I Line treatment Checkmate 214: IMDC Intermediate/Poor, PFS/IRRC
19
mRCC I Line treatment Checkmate 214: IMDC Intermediate/Poor, OS
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mRCC I Line treatment Checkmate 214: ITT, ORR/PFS/OS
22
mRCC I Line treatment Checkmate 214: Activity by PDL1 expression
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mRCC I Line treatment Checkmate 214: IMDC Intermediate/Poor, PFS by PDL1
24
mRCC I Line treatment Checkmate 214: Responders, OS/TTR/TTP/Duration of therapy
25
mRCC I Line treatment Checkmate 214: Sarcomatoid, Intermediate/Poor, OR
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mRCC I Line treatment Checkmate 214: Sarcomatoid, IMDC Intermediate/Poor, PFS IA
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mRCC I Line treatment Checkmate 214: Sarcomatoid, IMDC Intermediate/Poor, OS
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29
mRCC I Line treatment Checkmate 214
30
mRCC I Line treatment Checkmate 214
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mRCC I Line treatment Checkmate 214
32
mRCC I Line treatment Checkmate 214
33
mRCC I Line treatment Checkmate 214
34
mRCC I Line treatment Checkmate 214
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mRCC I Line treatment Checkmate 214
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mRCC I Line treatment Checkmate 214
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cc mRCC: I Line treatment Options
Slide 21
Presented By Robert Uzzo at 2019 ASCO Annual Meeting
CARMENA: Prospective, multicenter, open-label, randomized, phase 3 non-inferiority study
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
Slide 11
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
Patient characteristics (2) / classification by IMDC
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
Median Overall Survival (ITT), FU = 61.5 months
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
Slide 20
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
Median Overall Survival (ITT) Intermediate patients
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
Median OS (ITT) patients with 1 metastatic site vs >1
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
Secondary nephrectomy in Arm B (sunitinib alone)
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
Slide 32
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
58
Slide 14
Presented By Neeraj Agarwal at 2019 ASCO Annual Meeting
60
Slide 15
Presented By Neeraj Agarwal at 2019 ASCO Annual Meeting
62
63
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mRCC: I Line Treatment Options
Medical Treatments
VEGFR-TKI: Sunitinib, Pazopanib, Tivozanib
Immunotherapy: Nivolumab/Ipilimumab
MET-Inhibitors: Cabozantinib
Cytoreductive nephrectomy, Metastasectomy and post-operative
treatment
Active surveillance
Medical Treatments: Perspectives
VEGFR-TKI/Immunotherapy Associations:
Pembrolizumab/Axitinib
Atezolizumab/Bevacizumab
Avelumab/Sunitinib
Efficacy of therapy is improving…
Presented By Bradley McGregor at 2019 ASCO Annual Meeting
Not reached 23.3 (21.3, NR) Not reached Not reached
0.68 (0.46, 1.00) 0.81 (0.63, 1.03)c
Confirmed ORR, % (95% CI)
Complete response
43% (35, 50)
9%
35% (28, 42)
4%
37% (32, 41)
5%
33% (29, 38)
2%
a n = 460 for ORR analysis. b Event/patient ratio: PD-L1+, atezo + bev, 25% and sunitinib, 35%; ITT, atezo + bev, 27% and sunitinib, 31%.
c P = 0.09. The OS analysis did not pass the P value boundary of α = 0.0009 at the first interim analysis. Response and progression assessed by investigator; minimum follow-up, 12 months. Median follow-up, 15 months.
Motzer RJ, et al. ASCO GU 2018 [abstract 578].
Efficacy of therapy is improving…
Presented By Bradley McGregor at 2019 ASCO Annual Meeting
cc mRCC: I Line treatment Conclusions
What we know now…
Presented By Bradley McGregor at 2019 ASCO Annual Meeting
cc mRCC: I Line treatment Conclusions
1L Combination Therapy Trials of Approved Agents
Presented By Rana McKay at 2019 ASCO Annual Meeting
cc mRCC: I Line treatment Conclusions
1L Combination Therapy Trials – ITT
Presented By Rana McKay at 2019 ASCO Annual Meeting
cc mRCC: I Line treatment Conclusions
Slide 22
Presented By Neeraj Agarwal at 2019 ASCO Annual Meeting
Slide 23
Presented By Neeraj Agarwal at 2019 ASCO Annual Meeting
Sunitinib in mRCC with Brain Mets: Results from the Global Expanded Access Protocol
Presented By Neeraj Agarwal at 2019 ASCO Annual Meeting
Slide 25
Presented By Neeraj Agarwal at 2019 ASCO Annual Meeting