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Redefiniendo el Tratamiento del Cáncer Renal

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Presentation on theme: "Redefiniendo el Tratamiento del Cáncer Renal"— Presentation transcript:

1 Redefiniendo el Tratamiento del Cáncer Renal
Enrique Grande Head of Medical Oncology Director of Clinical Research

2 Disclosures Honoraria for ad boards and/or lectures:
Pfizer, BMS, IPSEN, Roche, Eisai, Eusa Pharma, MSD, Sanofi-Genzyme, Adacap, Novartis, Pierre Fabre, Lexicon, Celgene Research Grants: Pfizer, Astra Zeneca, MTEM/Threshold, Roche, IPSEN, Lexicon Leadership roles in medical societies: ENETS, GETNE and GETHI Stocks or ownership interest: None

3 Pathways and Current Drugs in Metastatic RCC
Choueiri & Motzer. N Engl J Med 2017

4 Curti BD. N Engl J Med 2018

5 Survival, Durable Response, and Long-Term Safety in Patients With Advanced RCC Receiving Nivolumab
Rini B, et al. 13th European International Kidney Cancer Symposium;April 27–28, 2018; Prague, Czech Republic

6 Spontaneous Regression in Renal Cancer
Bloom & Wallace. Br Med J 1964

7 ’Real World’ Immuno-Oncology Sequences
Presented By Daniel Heng at 2019 Genitourinary Cancers Symposium

8 Broad range of systemic treatment options
Adapted from NCCN v Guidelines.

9 Broad range of systemic treatment options
Active surveillance Adapted from NCCN v Guidelines.

10 Active surveillance in mRCC: a prospective, phase 2 trial
Median surveillance time 22.2 m Median surveillance time 8.4 m Active surveillance in patients with 0–1 IMDC risk factors and two or less organs involved with metastatic disease (favourable group) compared with all other patients (unfavourable group) Rini BI, et al. Lancet Oncol 2016

11 Broad range of systemic treatment options
Active surveillance Metastasectomy Adapted from NCCN v Guidelines.

12 Meta-analysis: Outcomes following complete metastasectomy
Zaid HB, et al. J Urol 2016

13 Broad range of systemic treatment options
Active surveillance Metastasectomy Cytoreductive Nephrectomy Adapted from NCCN v Guidelines.

14 Role of Cytoreductive Nephrectomy in the Cytokines era
Flanigan RC, et al. N Engl J Med. 2001 Mickish GHJ, et al. Lancet 2001

15 Role of Cytoreductive Nephrectomy in the Targeted Therapy era: Meta-anaalysis
García-Perdomo HA, et al. Investig Clin Urol 2018

16 CARMENA: Overall Survival
Méjean A, et al. N Engl J Med. 2018

17 Bex A, et al. Eur Urol 2018

18 Broad range of systemic treatment options
Active surveillance Metastasectomy Cytoreductive Nephrectomy Systemic Treatment Adapted from NCCN v Guidelines.

19 Broad range of systemic treatment options
Nivolumab Everolimus Sunitinib Temsirolimus Pazopanib Active surveillance Tivozanib Metastasectomy Single agents Sorafenib Cytoreductive Nephrectomy Axitinib Cabozantinib Systemic Treatment Beva + INF Lenvatinib + Eve Nivo + Ipi Combos Atezo + Beva? Avelumab + Axi? Adapted from NCCN v Guidelines. Pembro + Axi?

20 RCC: a rapidly evolving field
1992 … … 2005 … 2007 2008 2011 2009 2014 2011 2013 2016 2017 2018 2019 2L

21 RCC: a rapidly evolving field
INF vs IL-2 or combo 1992 … … 2005 … 2007 2008 2011 2009 2014 2011 2013 2016 2017 2018 2019 2L

22 PERCY Quattro trial: is there any better ’old’ immunotherapy for RCC?
Negrier S, et al. Cancer 2005

23 RCC: a rapidly evolving field
Sunitinib or Sorafenib INF vs IL-2 or combo 1992 … … 2005 … 2007 2008 2011 2009 2014 2011 2013 2016 2017 2018 2019 2L

24 First battle: Sunitinib vs Sorafenib
Sunitinib vs INF Sorafenib vs INF Motzer RJ, et al. N Engl J Med 2007 Escudier B, et al. J Clin Oncol 2009

25 RCC: a rapidly evolving field
Sunitinib or Sorafenib Sunitinib or Temsirolimus INF vs IL-2 or combo 1992 … … 2005 … 2007 2008 2011 2009 2014 2011 2013 2016 2017 2018 2019 2L

26 The Battle for Poor Risk and Non-Clear Cell Features: Temsirolimus – Global ARCC Trial
IFN + TEM TEM IFN 7.3 10.9 8.4 Hudes G, et al. N Engl J Med 2007

27 The Battle for Poor Risk and Non-Clear Cell Features
RECORD-3 Trial ASPEN Trial ESPN Trial Motzer RJ, et al. J Clin Oncol 2014 Armstrong AJ, et al. Lancet Oncol 2016 Tannir N, et al. Eur Urol 2016

28 The Battle for Poor Risk and Non-Clear Cell Features: Metaanalysis
Ciccarese C, et al. Eur J Cancer 2017

29 RCC: a rapidly evolving field
Sunitinib or Sorafenib Sunitinib or Temsirolimus INF vs IL-2 or combo 1992 … … 2005 … 2007 2008 2011 2009 2014 2011 2013 2016 2017 2018 2019 Everolimus or Sorafenib 2L

30 RECORD-1 trial: mTOR inhibition is active in refractory RCC
Motzer RJ, et al. Lancet 2008

31 RCC: a rapidly evolving field
Sunitinib or Sorafenib Sunitinib or Beva + INF Sunitinib or Temsirolimus INF vs IL-2 or combo 1992 … … 2005 … 2007 2008 2011 2009 2014 2011 2013 2016 2017 2018 2019 Everolimus or Sorafenib 2L

32 AVOREN and CALGB 90206 Trials: Pioneers in Doublets
8.5m 5.2m HR 0.63, 95% CI 0.52–0.75; p=0.0001 HR 0.71 (95% CI, 0.61 to 0.83; P ) Escudier B, et al. Lancet 2007 Rini B, et al. J Clin Oncol 2008

33 CALGB 90206 Trial Toxicity Profile (Grade 3 or 4 AEs)
Adverse event Bevacizumab + IFN (n=366) IFN (n=352) Any grade 3/4 adverse event 79% 61% Fatigue/asthenia/malaise 37% 30% Anorexia 17% 8% Proteinuria 15% <1% Hypertension 11% 0% Hemorrhage 2% Venous thromboembolism 1% Gastrointestinal perforation Arterial ischemia Rini B, et al. J Clin Oncol 2008

34 RCC: a rapidly evolving field
Sunitinib or Sorafenib Sunitinib or Beva + INF Sunitinib or Temsirolimus INF vs IL-2 or combo 1992 … … 2005 … 2007 2008 2011 2009 2014 2011 2013 2016 2017 2018 2019 Everolimus or Sorafenib 2L Axitinib or Everolimus

35 AXIS trial: Axitinib can overcome the resistance to sunitinib
Rini BI, et al. Lancet 2011

36 RCC: a rapidly evolving field
Sunitinib or Sorafenib Sunitinib or Beva + INF Sunitinib or Pazopanib Sunitinib or Temsirolimus INF vs IL-2 or combo 1992 … … 2005 … 2007 2008 2011 2009 2014 2011 2013 2016 2017 2018 2019 Everolimus or Sorafenib 2L Axitinib or Everolimus

37 COMPARZ Trial: Should we insist on Non-Inferiority Trials designs?
Motzer RJ, et al. N Engl J Med 2013

38 RCC: a rapidly evolving field
Sunitinib or Sorafenib Sunitinib or Beva + INF Sunitinib or Pazopanib Sunitinib or Temsirolimus INF vs IL-2 or combo 1992 … … 2005 … 2007 2008 2011 2009 2014 2011 2013 2016 2017 2018 2019 Everolimus or Sorafenib 2L Nivolumab or Cabozantinib Axitinib LENEVE Axitinib or Everolimus

39 Grande E, et al. World J Clin Oncol 2017

40 RCC: a rapidly evolving field
Sunitinib or Nivo/IPI Cabozantinib Atezo/Bev Pembro/Axi Avelu/Axi Tivozanib 1L Sunitinib or Sorafenib Sunitinib or Beva + INF Sunitinib or Pazopanib Sunitinib or Temsirolimus INF vs IL-2 or combo 1992 … … 2005 … 2007 2008 2011 2009 2014 2011 2013 2016 2017 2018 2019 Everolimus or Sorafenib 2L Nivolumab or Cabozantinib Axitinib LENEVE Axitinib or Everolimus

41 Sunitinib vs Ipilimumab + Nivolumab CheckMate 214 1.096 Reported
OS ITT HR 0.68 Int/poor risk Bevacizumab + Atezolizumab Immotion 151 915 PFS PDL1+ HR 0.74 Inv assess Axitinib + Avelumab Javelin Renal 830 PFS PDL1+ HR 0.61 IRC assess Axitinib + Pembrolizumab KEYNOTE 426 840 Press Release OS ITT HR 0.53 PFS ITT HR 0.69 Levatinib + Pembrolizumab CLEAR 1.050 Recruiting Est. Oct 2020 Lenvatinib + Everolimus Cabozantinib + Nivolumab CheckMate 9ER 1.014 Est. Feb 2021 Sunitinib vs The following references are available from 1. NCT ; 2. NCT ; 3. NCT ; 4. NCT ; 5. NCT ; 6. NCT ; 7. NCT ; 8. NCT ; 9. NCT ; 10. NCT ; 11. NCT ; 12. NCT

42 Sunitinib vs Ipilimumab + Nivolumab CheckMate 214 1.096 Reported
OS ITT HR 0.68 Int/poor risk Bevacizumab + Atezolizumab Immotion 151 915 PFS PDL1+ HR 0.74 Inv assess Axitinib + Avelumab Javelin Renal 830 PFS PDL1+ HR 0.61 IRC assess Axitinib + Pembrolizumab KEYNOTE 426 840 Press Release OS ITT HR 0.53 PFS ITT HR 0.69 Levatinib + Pembrolizumab CLEAR 1.050 Recruiting Est. Oct 2020 Lenvatinib + Everolimus Cabozantinib + Nivolumab CheckMate 9ER 1.014 Est. Feb 2021 Sunitinib vs The following references are available from 1. NCT ; 2. NCT ; 3. NCT ; 4. NCT ; 5. NCT ; 6. NCT ; 7. NCT ; 8. NCT ; 9. NCT ; 10. NCT ; 11. NCT ; 12. NCT

43 ESMO 2019 Guidelines (IA recommedations)
Good risk Intermediate risk Poor risk 1L Sunitinib Bevacizumab + IFN Pazopanib Tivozanib Nivolumab + ipilimumab Nivolumab + ipilimumab Post TKIs Post nivolumab + ipilimumab VEGF TKI VEGF MAb + IFN- 2L TKI + mTOR inhibitor Nivolumab Cabozantinib Any TKI Lenvatinib + everolimus PD-1 inhibitor (+ CTLA-4 inhibitor) Escudier B, et al. Ann Oncol 2019

44 @drenriquegrande

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