Sessione platinum series Best Papers

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1 Sessione platinum series Best Papers ormonoterapia G. Cartenì Direttore U.O.S.C. di Oncologia Medica A.O.R.N. A. Cardarelli Napoli 1

2 2 Enzalutamide

3 Enzalutamide: PREVAIL Studio di fase III Patients with visceral disease were allowed. 3 Beer TM, et al. J Clin Oncol 32, 2014 (suppl 4; abstr LBA1^)

4 Enzalutamide: PREVAIL Dati al basale 4 Beer TM, et al. J Clin Oncol 32, 2014 (suppl 4; abstr LBA1^)

5 Enzalutamide: PREVAIL Overall Survival 32m 30m Patients enrolled for the study generally had a good prognosis. Overall Survival: Enzalutamide Reduced the Risk of Death by 29%. 5 Beer TM, et al. J Clin Oncol 32, 2014 (suppl 4; abstr LBA1^)

6 Enzalutamide: PREVAIL PFS radiologica 30% of patients in the placebo group progressed at the first assessment. 6 Beer TM, et al. J Clin Oncol 32, 2014 (suppl 4; abstr LBA1^)

7 Enzalutamide: PREVAIL OS nei sottogruppi Non significativo Vantaggio su pazienti con prognosi migliore 7 Beer TM, et al. J Clin Oncol 32, 2014 (suppl 4; abstr LBA1^)

8 Enzalutamide: PREVAIL Safety 8 Beer TM, et al. J Clin Oncol 32, 2014 (suppl 4; abstr LBA1^)

9 PREVAIL Study of Enzalutamide in mcrpc: Conclusions Treatment with enzalutamide significantly: Reduced risk of death Delayed metastatic progression Achieved clinically meaningful response in soft tissue disease Delayed time to cytotoxic chemotherapy Delayed deterioration in quality of life Enzalutamide well tolerated over prolonged treatment 9 Beer T, et al. ASCO GU Abstract 1.

10 1 Abiraterone

Abiraterone: e COU AA 302 Design Phase 3 multicenter, randomized, double blind,

countries; USA, Europe, Australia, Canada Study permitted patients with ECOG

subjects had previous antiandrogen therapy followed by documented PSA or

11 Abiraterone: e COU AA 302 Design Phase 3 multicenter, randomized, double blind, blind, placebo controlled controlled study conducted at 151 sites in 12 countries; USA, Europe, Australia, Canada Study permitted patients with ECOG performance status of O or 1; this was stratified bt between study arms All subjects had previous antiandrogen therapy followed by documented PSA or radiographic progression after discontinuing antiandrogen therapy Ryan CJ, et al. N Engl J Med 2013;368:

12 Inclusion Criteria for mcrpc Abiraterone: COU AA 302 Inclusion criteria i Previous anti androgen therapy and progression after withdrawal ECOG performance status 0 or 1 Medical or surgical castration with testosterone < 50 ng/dl Exclusion Criteria: Prior cytotoxic chemotherapy or biologic therapy for CRPC Prior ketoconazole for prostate cancer Known brain metastasis or visceral organ metastasis Use of opiate analgesics for cancer related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1 Ryan CJ, et al. N Engl J Med 2013;368:

13 Abiraterone: COU AA 302 Dati al Basale a. Patients with BPI SF 2 or 3 are not eligible for opioids therapies. a. For study eligibility, a score of 0 1 on BPI SF Question #3 (worst pain in last 24 hours) will be considered asymptomatic, and a score of 2 3 will be considered mildly symptomatic. a. Consider that In the TAX 327 study : About 45% of patients t hd had pain, and about 40% had measurable soft tissue lesions. 1 Ryan CJ, et al. N Engl J Med 2013;368:

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15 Abiraterone: COU AA 302 updated analysis results Overall Survival 1

16 Abiraterone: COU AA 302 PFS radiologica 1 Ryan CJ, et al. N Engl J Med 2013;368:

17 Abiraterone: COU AA 302 Safety 1 Ryan CJ, et al. N Engl J Med 2013;368:

18 O S Considerazioni i i r a g g i u n t a 1 s

19 Phase III: Orteronel (TAK 700)/Prednisone vs Placebo/Prednisone in mcrpc Patients with mcrpc and progression on docetaxel, PSA 2 ng/ml (N = 1099) Orteronel (TAK 700) 400 mgbid + Prednisone 5 mg BID (n = 734) Placebo + Prednisone 5 mg BID (n = 365) Primary endpoint: OS Secondary endpoints: radiographic PFS, PSA response, pain response 1 Dreicer R, et al. ASCO GU Abstract 7.

20 Orteronel/Prednisone vs Placebo/ Prednisone in mcrpc: OS ty of Pts Surviving Probabili Pts at Risk, n Orteronel + prednisone Prednisone Median OS Orteronel: 17.0 mos Placebo: 15.2 mos HR: (95% CI: ; P =.18976) Events: 182 with orteronel vs 182 without Orteronel + Prednisone Prednisone Mos to Death Median follow up time: 10.7 mos (range: ) Dreicer R, et al. ASCO GU Abstract

21 Orteronel/Prednisone vs Placebo/ Prednisone in mcrpc: Radiographic PFS 2 hout ving With ssion Pts Surviv se Progre bability of Diseas Prob Pts at Risk, n Orteronel + Prednisone 734 Prednisone 365 Median PFS Orteronel: 8.3 mos Placebo: 5.7 mos HR: 0.76 (95% CI: ; P =.00038) Events: 262 with orteronel vs 466 without Prednisone Orteronel + Prednisone Mos to Radiographic PD or Death (15%) and 74 (20%) pts in the orteronel plus prednisone and prednisone groups, respectively, discontinued before radiographic progression. Dreicer R, et al. ASCO GU Abstract

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23 P r i m a r y Orteronel/Prednisone vs Placebo/ Prednisone in mcrpc: Conclusions e n d p o i n t o f 2 O SDreicer R, et al. ASCO GU Abstract 7.

24 Abstract 21 Response to androgen signaling (AS) directed therapy after treatment t twith abiraterone acetate tt (AA) in patients (pts) with metastatic castration resistant prostate cancer (mcrpc): Post hoc analysis of study COU AA 302. Matthew R. Smith et al pazienti arruolati nello studio COU AA 302 e trattati con abiraterone (pazienti chemonaïve) che hanno ricevuto enzalutamide (33 pazienti) o nuovamente abiraterone (55 pazienti) dopo l uscita dallo studio.

25 Abstract 240 Enzalutamide after abiraterone in patients with metastatic castrate resistant prostate cancer (mcrpc). Gurprataap Singh Sandhu et al. 23 pazienti Una riduzione del PSA 50% è stata descritta solo in 4 pazienti (17%) mentre la mediana di PFS biochimica era di 86 giorni. A 6 mesi, solo 2 pazienti presentavano una stabilità strumentale di malattia. 2

26 Abstract 159 Clinical activity of enzalutamide against metastatic castration resistant prostate cancer (mcrpc) in patients who have progressed on abiraterone acetate: The Princess Margaret experience. Francisco Emilio Vera Badillo et al. Sono stati arruolati in totale 26 pazienti, la durata mediana del trattamento è stata di 4,4 mesi (range 1,3 9,3 mesi) con interruzione dovuta a: progressione clinica o biochimica (92%) comparsa di fatigue di grado 3 4 in 2 pazienti (8%). 2 L analisi dei dati ha rilevato che in 7 (27%) dei pazienti trattati si è ottenuta una riduzione del PSA 50% e in ulteriori 7 (27%) una riduzione 30%. La PFS è stata di 4,9 mesi, in linea con quella riscontrata negli altri studi e migliore rispetto a quella ottenuta con abiraterone dopo enzalutamide.

27 Abstract 70 A prognostic score for patients with metastatic castration resistant prostate cancer treated with abiraterone acetate post chemotherapy. Arnoud J. Templeton et al. dati clinici e laboratoristici di 185 pazienti seguiti al Royal Marsden di Londra e successivamente valutati attraverso l analisi di regressione univariata di Cox. Il modello è stato validato utilizzando come riferimento il trial registrativo COU AA 301 2

28 Stretta correlazione tra sopravvivenza e NLR: i pazienti con NLR 5 al basale e che mostravano una riduzione del valore 5 entro le prime 4 settimane di trattamento hanno ottenuto una mos di 15 mesi, mentre quelli che mantenevano un valore di NLR 5 hanno ottenuto una mos di appena 7,6 mesi (HR 0,48; IC 95% 0,25 0,93; p=0,029). 2

29 RESISTANCE Click to edit the outline text format Second Outline Level Third Outline Level Fourth Outline Level Fifth Outline Level Sixth Outline Level Seventh Outline Level Eighth Outline Level AR - Ninth Outline LevelFare clic per AR + modificare stili del testo dello schema Secondo livello 2 Terzo livello P. Nelson, ASCO GU

30 Natural history and treatment Click to edit the outline text format progression of prostate cancer Second Outline Level Third Outline Level Fourth Outline Level Death Fifth Outline Level Sixth Outline Level Seventh Outline Level Eighth Outline Level Ninth Outline LevelFare clic per modificare stili del testo dello schema 3 Secondo livello Terzo livello Nguyen PL, et al. 2007; 110: Adapted

Outline Level Seventh Outline Level Eighth Outline Level Ninth Outline LevelFare clic per modificare

31 Natural history and treatment Click to edit the outline text format progression of prostate cancer Second Outline Level Third Outline Level Fourth Outline Level Death Fifth Outline Level Sixth Outline Level Seventh Outline Level Eighth Outline Level Ninth Outline LevelFare clic per modificare stili del testo dello schema 3 Secondo livello Terzo livello Nguyen PL, et al. 2007; 110: Adapted

SESSIONE PLATINUM SERIES (Best Papers Poster o Abstract on Prostate Cancer) In Oncologia

SESSIONE PLATINUM SERIES (Best Papers Poster o Abstract on Prostate Cancer) In Oncologia Divisione di Oncologia Medica Unità Tumori Genitourinari SESSIONE PLATINUM SERIES (Best Papers Poster o Abstract