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2 Theoretical tips It has been reasoned that discontinuation of ADT in nonorchiectomized patients may have detrimental effect on patients with CRPC as discontinuation of ADT can result in renewed release of testosterone and possible stimulation of remaining androgen sensitive elements. When exogenous testosterone therapy is administeredto to patients with symptomatic CRPC, adverse responses can be induced.

3 Taylor (JCO 1993) retrospective (341 pts) continued testicular androgen suppression was an important tpredictor of survival lduration (modest advantage) Hussain (JCO 1994) retrospective (205 pts) no obvious bi advantages in response to chemotherapy or survival for pts with continued gonadal suppression Lee (Am J Clin Oncol 2011) prospective (78 pts) brr (48.7% vs 66.7% p=0.27) PFS (4.9 mosvs5.0 mos p=0.57)

4 ADT is advocated to be used continuously, when chemotherapy is proposed p for CRPC

5

6 1990 s scenario HT XRT PIB HT HT CHT RP HT CHT hormone res metastases

7 Mitoxantrone Tannock JCO 1996; 14:1756 MIT+PDN PDN Kantoff JCO 1999; 17: 2506 MIT+HC HC Better palliation with MIT Increased DFS with MIT No differences in survival

8 SWOG and TAX studies in HRPC

9 TAX327 original results Pr robability of Surviving D 3 wkly 0.8 D wkly 0.7 Mitoxantrone Median Hazard Survival Ratio P value Combined: D 3 wkly: D wkly: Mitoxantrone: Months Tannock et al, N Engl J Med 2004; 351: months

10 TAX327 confirmatory data of survivi ing Pro obability Docetaxel q3w Docetaxel qw Mitoxantrone Median survival Hazard (months) ratio p value Docetaxel q3w: Docetaxel qw: Mitoxantrone Years months 48 months Berthold DR, et al. J Clin Oncol 2008;26:

11 1990 s scenario HT XRT PIB HT HT CHT RP HT CHT hormone res metastases

12 2004 scenario HT XRT PIB HT HT CHT RP HT CHT hormone res metastases

13

14 M0 Maintain castration levels of testosterone Clinical trial Observation Further hormonal manipulation ASYMPTOMATIC M1 Maintain castration levels of testosterone SYMPTOMATIC only bone mets DOC Zoledronic acid SYMPTOMATIC visceral mets DOC

15 TAX327:Multivariate Cox proportional p hazards Variable Multivariate 95% CI p value HR Liver metastases Number of metastatic sites (>2 vs 2) Pain at baseline < Performance status ( 70 vs 80) Progression type Measurable disease Bone scan Baseline PSA doubling time (<55 days vs 55 days) Baseline log PSA (for every unit rise in log(psa) in ng/dl) <0.001 Tumour grade (Gleason 8 or WHO 3 4 vs Gleason 7 or WHO 2 3) Alkaline phosphatase (log scale) (per log unit rise, IU/L Haemoglobin) Haemoglobin (per unit rise, g/dl) Armstrong et al Clin Canc Res 2007;13:

16 Prognostic Nomogram in CRPC Chemotherapy type Liver metastases Number of sites Pain at baseline Points Weekly Doce (6) Q3 Doce Mitox (18) No Yes (23) <=2 >2 (22) No Yes (18) Karnofsky performance status >=80 <70 (15) Progression type: Measurable disease No Yes (15) Progression type: Bone scan progression No Yes (12) Tumour grade Baseline PSA (ng/ml) Alkaline phosphatase (IU/L) Haemoglobin (g/dl) Baseline PSA doubling time Total points Median survival time (mo) Low Grade 0 18 High Grade (8) (5) 1 2 (13) 14 >6 2 3 (12) <1 (19) yr survival probability yr survival probability 5 yr survival probability Armstrong et al Clin Canc Res 2007;13:

17 Simplified Model Risk factors Anemia (hemoglobin <13.0) laboratory data Progression by bone scan criteria clin. data Visceral metastases clin. data Presence of clinically significant pain (TAX 327 definition) clin. data Armstrong et al Clin Canc Res 2007;13:

18 Simplified Model

19 Simplified Model Low Risk: 0-1 risk factors Intermediate Risk: 2 risk factors High Risk: 3-4 risk factors

20

21 TAX 327 Survival: pain vs no pain/minimal Docetaxel q3w Docetaxel qw Mitoxantrone (n = 335) (n = 334) (n = 337) N O P A I N P A I N n Median survival Hazard ratio p value n Median survival Hazard ratio p value Berthold DR, et al. J Clin Oncol 2008;26:242 45

22 TAX 327 Survival: pain vs no pain/minimal Docetaxel q3w Docetaxel qw Mitoxantrone (n = 335) (n = 334) (n = 337) N O P A I N P A I N n Median survival Hazard ratio p value n Median survival Hazard ratio p value Berthold DR, et al. J Clin Oncol 2008;26:242 45

23 Pre Treatment PSA DT PSADT >6 months PSADT 4 6 months PSADT 2 3 months PSADT 1 2 months PSADT <1 month Surviva al (%) and 3-6 Med OS NYR mean OS 25 and 22.5 months < 1 mo months 0 Log-rank p< Survival (months) Armstrong et al Clin Canc Res 2007;13:

24 Overall Survival according to bone pain intensity i and PSA doubling time (DT) No or minimal pain Mild pain Moderate or severe (n=79) (n=41) pain (n=25) Median OS 21.4 mos ( ) 15 mos ( ) 13.1 mos ( ) PSA DT > 45 days 32.4 mos 18.4 mos 16.1 mos PSA DT < 45 days 16.5 mos 11.2 mos 8.3 mos OS at 1 year (%) 75% 56% 52% OS at 2 years (%) 43% 20% 20% OS at 3 years (%) 29% 11% 4% S. Oudard et al, 2009, 103, 12:

25 M0 Maintain castration levels of testosterone Clinical trial Observation Further hormonal manipulation ASYMPTOMATIC M1 Maintain castration levels of testosterone SYMPTOMATIC only bone mets DOC Zoledronic acid SYMPTOMATIC visceral mets DOC

26 M0 Maintain castration levels of testosterone Clinical trial Observation Further hormonal manipulation ASYMPTOMATIC T slow growth Clinical trial Further hormonal manipulation Immunotherapy M1 Maintain castration levels of testosterone ASYMPTOMATIC fast growth SYMPTOMATIC only bone mets DOC Clinical trial DOC Zoledronic acid SYMPTOMATIC visceral mets DOC

27

28 2013 scenario HT manipulations D O C E T A X E L abiraterone cabazitaxel enzalutamide HSPC CRPC

29 new scenario around the corner HT manipulations D O C E T A X E L abiraterone cabazitaxel enzalutamide PREVAIL TERRAIN HSPC CRPC

30 new scenario around the corner

31 new scenario around the corner n = 1680 mcrpc asymptomatic or mildly symptomatic progression after ADT PREVAIL 1 (EU enrolment completed) R Enzalutamide 160 mg qd Placebo qd n = 370 mcrpc post LHRH failure or bilateral orchiectomy TERRAIN 2 R Enzalutamide 160 mg qd Bicalutamide 50 mg qd PREVAIL is a phase III randomised, double blind, placebo controlled trial Co primary primaryendpoints: OS and PFS TERRAIN is a phase II randomised, double blind efficacy and safety study of enzalutamide versus bicalutamide Primary endpoint: PFS /MDV10034_3004_EMUC.pdf ADT, androgen deprivation therapy; LHRH, luteinizing hormone releasing hormone; mcrpc, metastatic castrate resistant prostate cancer; OS, overall survival; PFS, progression free survival; R, randomisation; qd, once per day

32 new scenario around the corner HT manipulations D O C E T A X E L abiraterone COU-302 cabazitaxel FIRSTANA enzalutamide PREVAIL TERRAIN HSPC CRPC

33 new scenario around the corner abiraterone COU-302 HT manipulations cabazitaxel FIRSTANA enzalutamide PREVAIL TERRAIN HSPC CRPC

34 open questions CT HT vs HT CT ENZ ABI vs ABI ENZ combination therapy

35 CT HT vs HT CT

36 CT HT vs HT CT Author sequence # pts brr mos Mezynski ABI DOC 35 26% 12.5 m Aggarwal* KETO DOC % 21.1 m Pond** KETO DOC % 17.0 m *no differences compared to 728 pts not treated with KETO ** better trend without significance compared to 180 pts not treated with KETO after adjustment

37 ENZ ABI vs ABI ENZ

38 ENZ ABI vs ABI ENZ Author sequence # pts brr mpfs Loriot ENZ ABI 38 8% 2.7 m Noonan ENZ ABI 30 3% 3.8 m Schrader ABI ENZ % NR

39 combination therapy

40 ALLIANCE A mcrpc chemo naïve patients (N=1400) Stratification factors prior chemo (for no mets) ENZALUTAMIDE ENZALUTAMIDE ABIRATERONE PREDNISONE

41

42

43 Sipuleucel T: Autologous APCs Cultured with Antigen Fusion Protein Recombinant Prostatic Acid Phosphatase (PAP) fusion antigen combines with resting antigen presenting cell (APC) APC takes up the antigen Antigen is processed and presented on surface of the APC Active T-cell Fully activated, the APC is now sipuleucel-t Inactive INFUSE PATIENT T-cell T-cells proliferate and attack cancer cells sipuleucel-t activates T-cells in the body The precise mechanism of sipuleucel-t in prostate cancer has not been established.

44 PSA TRICOM (PROSTVAC) is a vector based vaccine consisting of recombinant fowlpox boosts which contains transgenes for PSA and three co stimulatory molecules (TRICOM)

45 Randomized Phase 3 IMPACT Trial (IMmunotherapy Prostate AdenoCarcinoma Treatment) Asymptomatic or Minimally Symptomatic Metastatic Castration Resistant Prostate t Cancer (N=512) 2:1 Sipuleucel-T Q 2 weeks x 3 Placebo Q 2 weeks x 3 P R O G R E S S I O N Treated at Physician Discretion Treated at Physician Discretion and/or Salvage Protocol S U R V I V A L Primary Endpoint: Overall Survival Secondary Endpoint: Objective Disease Progression

46 P = (Cox model) HR = [95% CI: 0.614, 0.979] Median Survival Benefit = 4.1 Mos. (25.8 vs 21.7)

47 Metastatic Castration Resistant Prostate Cancer (N=125) 2:1 PROSTVAC Q 4 weeks x 6 Placebo Q 4 weeks x 6 Primary Endpoint: Progression Free Survival

48

49

50 Tumor Growth Rate Tumor Bu urden Time

51 Sipuleucel T: Logistics of Therapy Day 1 Day 2-3 Day 3-4 Leukapheresis sipuleucel-t is manufactured Patient is infused Apheresis Center Central Processing Doctor s Office COMPLETE COURSE OF THERAPY: COMPLETE COURSE OF THERAPY: Weeks 0, 2, 4

52

53 parameters clinical issues performance status pain laboratory issues PSA bone biomarkers imaging issues CT scan bone scan PET scan (??)

54 objectives true PD to avoid late therapy stop (for on treatment pts) to avoid later therapy start (for off treatment pts) false PD to avoid early therapy stop (for on treatment pts) to avoid early therapy start (for off treatment pts)

55 on treatment regular PSA assessment biochemical PD requires radiological confirmation of progression to lead to therapy end regular clinical status assessment baseline and final instrumental assessment CT : on demand during the treatment HT : every 4 6 months

56 off treatment regular PSA assessment biochemical PD should be confirmed by radiological assessment clinical status should be regularly monitored to avoid a deterioration which prevents further treatments to detect symptoms appearance no regular instrumental follow up should be planned

When exogenous testosterone therapy is. adverse responses can be induced.

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