Second line. Elena Verzoni Oncologia Medica Fondazione IRCCS Istituto Nazionale Tumori Milano

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1 mcrpc: First and Second line Elena Verzoni Oncologia Medica Fondazione IRCCS Istituto Nazionale Tumori Milano

2 Landmarks of disease progression in CRPC 2-10 years 30 months Failed localized therapy Hormonal therapy chemotherapy palliation LHRH analogues, antiandrogenis, ADT death Tumour bur rden diagnosis PSA rises Asymptomatic Symptomatic Hormone sensitive Prostate t Cancer Castration resistant ti it tprostate t Cancer (HSPC) * (CRPC) M0 M+

3 Castration Resistant Prostate Cancer NON METASTATIC disease OLIGOMETASTATIC disease /asymptomatic or mildly symptomatic patients METASTATIC disease/symptomatic > Chemo naïve patients > After docetaxel

4 NON METASTATIC CASTRATION RESISTANT disease No standard dtreatmentt t Non efficacy data available from docetaxel based chemo

5 CASTRATION RESISTANT RESISTANT OLIGOMETASTATIC disease: Asymptomatic/ ti /Mildly Symptomatic ti Patients Pti t PRE DOCETAXEL

6 ABIRATERONE ENZALUTAMIDE PRE DOCETAXEL

7 PREVAIL End points di efficacia Pazienti mcrpc chemo- naïve in progressione Co-Primari: R (N = 1717) A rpfs (central review) N Progressione del PSA in Enzalutamide 160 mg QD OS accordo con i criteri PCWG2 D O (n=872) o progressione radiologica M Secondari: I Tempo all uso di Terapia di deprivazione Z oppiacei (dolore androgenica in corso A correlato al tumore) T Tempo all inizio della ECOG PS di grado 0 o 1 I Placebo QD O chemioterapia (n =845) Asintomatici o lievemente N Tempo al primo evento sintomatici, in accordo con scheletrico BPI-SF 1:1 Tempo alla (scores da 0 a 1 [asintomatico] progressione PSA o da 2 a 3 [paucisintomatico])

8 Enzalutamide: Analisi OS OS 32.4 mos OS 30.2 mos Stopped at first interim i rpfs 12 mo: 65% vs 14% Beer T et al. N Engl J Med 2014;

9 COU-AA-302 Pazienti mcrpc chemo-naïve in progressione (N = 1088) Progressione del PSA in accordo con i criteri PCWG2 o progressione radiologica Terapia di deprivazione androgenica in corso ECOG PS di grado 0 o 1 Asintomatici o lievemente sintomatici, in accordo con BPI- SF (scores da 0 a 1 [asintomatico] ti o da 2 a 3 [paucisintomatico]) R A N D O M I Z A T I O N 1:1 Abiraterone acetato 1000 mg QD Prednisone 5 mg BID (n = 546) Prednisone 5 mg BID Placebo QD (n = 542) End points di efficacia Co-Primari: rpfs (central review) OS Secondari: Tempo all uso di oppiacei (dolore correlato al tumore) Tempo all inizio della chemioterapia Tempo al deterioramento t dell ECOG PS TTPP Ryan et al, N Engl J Med 2013

10 Abiraterone: Analisi OS Median follow-up of 49.2 months Abiraterone treatment effect more pronounced when adjusting for 44% of prednisone patients who received subsequent abiraterone (HR = 0.74) Ryan C et al. ESMO 2014; Abstract 7530 (oral presentation)

11 CASTRATION RESISTANT RESISTANT OLIGOMETASTATIC disease: Symptomatic ti Patients Pti t

12 2004: First line Docetaxel: Overall Survival TAX 327 SWOG 9916 Docetaxel therapy led to improved survival and rates of response in terms of pain, PSA level, and quality of life compared with mitoxantrone/prednisone Docetaxel/estramustine improved median survival by 2 months compared with mitoxantrone/prednisone 1. Tannock IF et al NEJM Petrylak DPet al NEJM 2004

13 I Linea: Docetaxel +? Agent Target Summary of trial Status Bevacizumab VEGF Docetaxel vs Docetaxel+Bevacizumab Aflibercept VEGF-trap Docetaxel vs Docetaxel+Aflibercept t Lenalidomide Antiangiogenic Docetaxel vs Docetaxel+Lenalidomide Atrasentan Zibotentan Dasatinib Endothelin receptor Endothelin receptor Src kinase, BCR- ABL, ckit, PDGFR Docetaxel vs Docetaxel+Atrasentan Docetaxel vs Docetaxel+Zibotentan Docetaxel vs Docetaxel+Dasatinib NEGATIVE NEGATIVE NEGATIVE OPEN TO ACCRUAL NEGATIVE NEGATIVE Custirsen (OGX) Clusterin Docetaxel vs NEGATIVE Docetaxel+ Cutrirsen DN-101 Vitamin D receptor Docetexel vs Docetaxel+DN-101 NEGATIVE GVAX Whole-cell vaccine Docetaxel vs Docetaxel+GVAX NEGATIVE

14 METASTATIC CASTRATION RESISTANT disease POST DOCETAXEL

15 Post docetaxel Options available What s the best sequence to maximize survival? Abiraterone ADT Docetaxel Cabazitaxel PD PD CYP 17 inhibitor Chemo New generation antiandrogen No data available for the best sequencing Docetaxel rechallenge Enzalutamide

16 De Bono JS et al. Lancet 2010; TROPIC Trial: OS Proportion of OS (%) Time (months)

17 Abiraterone post docetaxel: COU AA 301 De Bono NEJM 2011 analisi ad interim studio 301 Fizazi Lancet Oncology 2012 analisi finale studio 301 Logothetis Lancet Oncology 2012 Sottoanalisi i studio 301 su Dolore e SRE SECONDARY ENDPOINTS Sternberg Annals of Oncology 2012 Sottoanalisi studio 301 su Fatigue Harland abstract ASCO 2011 Sottoanalisi studio 301 su QoL

18 COU AA 301 Study Design Phase 3, multinational, multicenter, randomized, double blind, placebo controlled study (147 sites in 13 countries; USA, Europe, Australia, Canada) 1195 pts con mcrpc in progressione Fallimento 1 o 2 precedenti regimi di CT, uno dei quali a base Docetaxel Randomizzazione 2:1 Stratificazione per: ECOG PS (0 1 vs. 2) Maggior intensità di dolore nelle ultime 24 ore (BPI short form; 0 3 [assente] vs [presente]) Precedente chemioterapia (1 vs. 2) Tipo di progressione (solo PSA vs. Rx PD con o senza PSA PD) ABIRATERONE ACETATO 1000 mg QD Prednisone 5 mg BID Placebo QD Prednisone 5 mg BID F I N O A P R O G R E S S I O N E Primary Endpoint: OS (miglioramento del 25%; HR 0.8) de Bono et al. NEJM 2011; 364:

19 COU AA 301: Overall Survival 100 Hazard Ratio (95% CI): 0.74 ( ) 0 859) P < Surviva al (%) AA/Pdn Placebo/Pdn Placebo + prednisone OS 11.2 mesi (95% CI; ) Abiraterone + prednisone: OS 15.8 mesi (95% CI; ) Time to Death (Months) Braccio Abiraterone Mesi Fizazi et al. Lancet Oncol 2012; 13(10):

20 MDV3100 Phase 3 AFFIRM study: post docetaxel Pti Patient t Population 1199 patients with progressive CRPC Failed docetaxel chemotherapy h Randomised 2:1 MDV mg daily (n=800) Placebo (n=399) Primary end point: OS Secondary endpoints: PSA response OR TTPSA progression rpfs Time to 1st SRE QoL * Glucocorticoids were not required but allowed Scher HI et al. NEJM 2012; 367:

21 AFFIRM Overall survival: Median benefit 4.8 months mos 18.4 mo vs 13.6 mo (p<0.0001) HR 0.63 Scher HI et al. NEJM 2012; 367:

22

23 Radium 223 Targets Bone Metastases

24 ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) Phase III Study Design TREATMENT PATIENTS Confirmed symptomatic CRPC 2 bone metastases No known visceral metastases Postdocetaxel or unfit for docetaxel STRATIFICATION Total ALP: < 220 U/L vs 220 U/L Bisphosphonate use: Yes vs No Prior docetaxel: Yes vs No R A N D O M I S E D 2:1 N = injections at 4 week intervals Radium 223 (50 kbq/kg) + Best standard of care Placebo (saline) + Best standard of care Planned follow up is 3 years

25 ALSYMPCA Time to First Skeletal Related Event % Without SR RE HR 0.610; 95% CI, P = Placebo, n = 268 Median: 8.4 months Radium 223, n = 541 Median: 13.6 months Month Radium Placebo

26 ALSYMPCA Overall Survival HR 0.695; 95% CI, P < % Placebo, n = 268 Median OS: 11.3 months Radium 223, n = 541 Median OS: 14.9 months 0 Month Radium Placebo

27

28

29 Which drug for which patient? Do we have any choice criteria?

30 Caratteristiche dei pazienti dello studio PREVAIL/COUAA302 Characteristics Enzalutamide (n=872) Placebo (n=845) Characteristics Abiraterone (n = 546) Prednisone (n = 542) Median age (43-93) 31.4% 4.9% 71 (42-93) 28.4% 6.2% Median age, years (range) 71 (44-95) 70 (44-90) Median time from initial diagnosis to first dose (years) Gleason score 8 at initial diagnosis 50.6% 52.4% Median PSA (ng/ml) Distribution of disease at screening Bone Lymph node Visceral disease (lung or liver) Visceral liver Visceral lung Visceral lung or liver Other soft tissue 85.0% 50.1% 11.2% 4.6% 73% 7.3% 0.7% 13.0% 81.7% 51.4% 12.5% 4.0% 89% 8.9% 0.4% 12.4% Gleason score ( 8) at initial diagnosis 54% 50% Extent of disease Bone metastases 83% 80% > 10 bone metastases 49% 47% Soft tissuea 49% 50% No. of bone metastases at screening 32.7% 32.2% >10 Baseline pain 0-1 on BPI SF-Q3 66.2% 67.5% Pain (BPI-SF) % 64% % 33% BPI SF, Brief Pain Inventory Short Form (scale 0 10). Beer T et al. N Engl J Med 2014; epub (Supplementary Data)

31 Caratteristiche dei pazienti dello studio COUAA301

32

33 Cabazitaxel: TROPIC Caratteristiche dei pazienti al basale De Bono JS, et al. Lancet 2010; 376:

34 Cabazitaxel: malattia aggressiva (PD: PSA + dolore + radiologia) Fattori predittivi di efficacia nel CRPC progredito al Docetaxel. De Bono JS, et al. Lancet 2010; 376:

35 Caratteristiche dei pazienti dello studio AFFIRM

36

37

38 Take home messages New drugs are now available in different setting > OS improvement!! No comparative data No data about sequencing

39 Take home messages Sites of disease Burden Symptoms Different safety ft profile/os ev Age, PS, Comorbidity

40 Grazie dell attenzione! mi it

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