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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
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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
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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)
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Lee et al, Ann Onc 2015
Bracarda et al, Ann Onc 2016
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mRCC: I Line treatment IMDC risk Prognostic Score
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mRCC: I Line treatment Checkmate 214
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mRCC: I Line treatment Checkmate 214, Baseline Characteristics
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mRCC I Line treatment Checkmate 214: IMDC Intermediate/Poor, OR/DOR
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mRCC I Line treatment Checkmate 214: IMDC Intermediate/Poor, PFS/IRRC
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mRCC I Line treatment Checkmate 214: IMDC Intermediate/Poor, OS
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mRCC I Line treatment Checkmate 214: ITT, ORR/PFS/OS
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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
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mRCC I Line treatment Checkmate 214: Responders, OS/TTR/TTP/Duration of therapy
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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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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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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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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
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Slide 21
Presented By Robert Uzzo at 2019 ASCO Annual Meeting
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CARMENA: Prospective, multicenter, open-label, randomized, phase 3 non-inferiority study
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
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Slide 11
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
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Patient characteristics (2) / classification by IMDC
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
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Median Overall Survival (ITT), FU = 61.5 months
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
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Slide 20
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
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Median Overall Survival (ITT) Intermediate patients
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
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Median OS (ITT) patients with 1 metastatic site vs >1
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
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Secondary nephrectomy in Arm B (sunitinib alone)
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
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Slide 32
Presented By Arnaud Mejean at 2019 ASCO Annual Meeting
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Slide 14
Presented By Neeraj Agarwal at 2019 ASCO Annual Meeting
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Slide 15
Presented By Neeraj Agarwal at 2019 ASCO Annual Meeting
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64 64
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
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Efficacy of therapy is improving…
Presented By Bradley McGregor at 2019 ASCO Annual Meeting
mRCC: I Line treatment Conclusions
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861
(FASE3)
KPS < 80% -Interval from diagnosis to metastatic disease < 12months -Corrected serum calcium >10 mg/dl - Platelets > ULN - Neutrophils > ULN - Low Hb
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KEYNOTE-426: OS in the ITT Population
Presented By Brian Rini at 2019 ASCO Annual Meeting
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IMDC Favorable Risk: OS, PFS, and ORR
Presented By Brian Rini at 2019 ASCO Annual Meeting
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IMDC Intermediate/Poor Risk: OS, PFS, and ORR
Presented By Brian Rini at 2019 ASCO Annual Meeting
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PFS: Presence of Sarcomatoid Featuresa
Presented By Brian Rini at 2019 ASCO Annual Meeting
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IMmotion151 Study Design
Key eligibility
• Treatment-naive advanced or metastatic RCC
• Clear cell and/or sarcomatoid histology
• KPS ≥ 70 • Tumor tissue available for
PD-L1 staining
R
1:1
Atezolizumab 1200 mg IV q3w
+
Bevacizumab 15 mg/kg IV q3w
Sunitinib 50 mg PO QD (4 weeks on, 2 weeks off)
N = 915
Stratification
•MSKCC risk score
•Liver metastases
•PD-L1 IC IHC status (< 1% vs ≥ 1%)a
Co-primary endpoints
• PFS by INV assessment in PD-L1+ • OS in ITT
Other key endpoints • PFS in ITT • OS in PD-L1+
• ORR
• Patient-reported outcomes
• Safety
IC, tumor-infiltrating immune cell; IHC, immunohistochemistry; INV, investigator; IRC, independent review committee; ITT, intent-to-treat; IV, intravenous; ORR, overall response rate; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; PO, by mouth; R, randomized; RCC, renal cell carcinoma; KPS, Karnofsky Performance Status; MKSCC, Memorial Sloan
Kettering Cancer Center; q3w, every 3 weeks; QD, once a day. a 40% prevalence using SP142 IHC assay.
Motzer RJ, et al. ASCO GU 2018 [abstract 578].
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Progression-Free Survival in the PD-L1+ Population
Median PFS, mo (95% CI)
Atezo + Bev 11.2 (8.9, 15.0)
Sunitinib 7.7 (6.8, 9.7)
HR, 0.74 (95% CI: 0.57, 0.96)
P = 0.02a
PFS assessed by investigators. Minimum follow-up, 12 months. Median follow-up, 16 months.
a The PFS analysis passed the pre-specified P value boundary of α = 0.04.
Motzer RJ, et al. ASCO GU 2018 [abstract 578].
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Efficacy Summary
PD-L1+ ITT
Atezo + Bev
n = 178
Sunitinib
n = 184
Atezo + Bev
n = 454
Sunitinib
n = 461a
Median PFS, mo (95% CI)
Stratified HR, (95% CI)
11.2 (8.9, 15.0) 7.7 (6.8, 9.7) 11.2 (9.6, 13.3) 8.4 (7.5, 9.7)
0.74 (0.57, 0.96) 0.83 (0.70, 0.97)
Overall survival, mo
Interim analysisb
Stratified HR, (95% CI)
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].
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Efficacy of therapy is improving…
Presented By Bradley McGregor at 2019 ASCO Annual Meeting
cc mRCC: I Line treatment Conclusions
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What we know now…
Presented By Bradley McGregor at 2019 ASCO Annual Meeting
cc mRCC: I Line treatment Conclusions
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1L Combination Therapy Trials of Approved Agents
Presented By Rana McKay at 2019 ASCO Annual Meeting
cc mRCC: I Line treatment Conclusions
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1L Combination Therapy Trials – ITT
Presented By Rana McKay at 2019 ASCO Annual Meeting
cc mRCC: I Line treatment Conclusions
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Slide 22
Presented By Neeraj Agarwal at 2019 ASCO Annual Meeting
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Slide 23
Presented By Neeraj Agarwal at 2019 ASCO Annual Meeting
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Sunitinib in mRCC with Brain Mets: Results from the Global Expanded Access Protocol
Presented By Neeraj Agarwal at 2019 ASCO Annual Meeting
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Slide 25
Presented By Neeraj Agarwal at 2019 ASCO Annual Meeting