Upda%ng Concepts Biosynthesis Inhibitors and An%- Androgens. Neal D. Shore IPCU 2017
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1 Upda%ng Concepts Biosynthesis Inhibitors and An%- Androgens Neal D. Shore IPCU
2 The Human Endocrine System Drives Prostate Cancer Growth Hypothalamus (Brain) Estrogen LHRH agonists (Lupron, Zoladex) LHRH Pituitary Gland orchiectomy FSH, LH Testicles Testosterone Adrenal gland Abiraterone Abiraterone DHT PROSTATE CANCER CELLS Antiandrogens: Casodex Flutamide Nilutamide,, Apalutamide
3 Prostate Cancer can make its own androgens 1. Transcripts encoding steroidogenic enzymes are detected within tumor 2. Tumor androgens in CRPC metastases from anorchid patiencts exceed levels in prostate cancer tissues from eugonadal subjects 3. These may be particularly relevant for tumors with overexpressed AR Montgomery RB et alcancer Res Jun 1;68(11):
4 Abiraterone: A CYP 17 Inhibitor Low-dose steroid replacement reduces mineralocorticoid-related toxicity! Cholesterol No Prednisone! Prednisone! Pregnenolone Progesterone DOC Corticosterone Aldosterone SALT Mineralocorticoids T! CYP17 17α-hydroxylase T! Abiraterone HTN Low K+ 17α-OHpregnenolone 17α OHprogesterone 11-Deoxycortisol Cortisol SUGAR Glucocorticoids T! CYP17 C17,20-lyase T! Abiraterone DHEA Androstenedione Testosterone DHT SEX Androgens Estradiol Source: Attard et al. J Clin Oncol. 2008;26: ; Ryan et al. J Clin Oncol. 2010;28: !
5 Higher AR levels in CRPC tumors AR expression in Bone Marrow Mets Stanbrough et al Cancer Research CRPC samples have robust AR expression Mohler et al Holzberlein et al Am J Pathology At autopsy 73% of 15 samples exhibit AR amplification. Friedlander/Paris et al
6 (Xtandi) Oral drug ra%onally designed to target AR signaling, impac%ng mul%ple steps in AR signaling pathway. No demonstrated agonist effects in pre- clinical models. 1 2 T Inhibits Binding of Androgens to AR Cell cytoplasm Inhibits Nuclear Translocation of AR T AR Cell nucleus AR 3 Inhibits Association Of AR with DNA Tran et al. Science 2009;324:
7 Two very ac%ve agents Abiraterone/Pred vs Prednisone Vs Placebo Radiographic Progression-Free Survival (%) Placebo Hazard Ratio: (95% CI: 0.15, 0.23) P< Radiographic Progression-Free Survival (Months) Hazard Ratio: (95% CI: 0.60,0.84) P< Survival (%) Patients at Risk 872 Placebo 845 Placebo Ryan et al NEJM 2013, Lancet Onc 201 Beer et al NEJM Duration of Overall Survival (Months) Patients still alive at data cut off : 72%; Placebo: 63%
8 Two very ac%ve agents Abiraterone/Pred vs Prednisone vs Placebo Radiographic Progression-Free Survival (%) Placebo Hazard Ratio: (95% CI: 0.15, 0.23) P< Radiographic Progression-Free Survival (Months) Hazard Ratio: (95% CI: 0.60,0.84) P< Survival (%) Patients at Risk 872 Placebo 845 Placebo Ryan et al NEJM 2013, Lancet Onc 201 Beer et al NEJM Duration of Overall Survival (Months) Patients still alive at data cut off : 72%; Placebo: 63%
9 Post Chemotherapy: Phase 3 Trial (AFFIRM) Kaplan Meier Estimates of Primary and Secondary End Points in the Intentionto-Treat Population. vs Placebo Scher HI et al. N Engl J Med DOI: /NEJMoa
10 Post Chemotherapy: COU-AA-301: Abiraterone Acetate vs Placebo/Prednisone 100 Abiraterone acetate: 14.8 months 80 Survival (%) Placebo: 10.9 months AA Placebo HR = ( ) P < Days From Randomization AA Placebo
11 Sequencing: Retrospec1ve Experience Abiraterone a8er enzalutamide Very Modest response Study N Sequence (order drugs administered) Ileana Docetaxel Abiraterone Noonan Docetaxel Abiraterone Loriot Docetaxel Abiraterone PSA Response Therapy ( 50%) PSA Response ( 50%) Response to Abiraterone Therapy Median PFS Median OS - 13% 2.4 months - 60% 3% 15.4 weeks 50.1 weeks - 8% 2.7 months 7.2 months
12 Sequencing: a8er Abiraterone be#er outcome? Study N Sequence (order drugs administered) Bianchini 2013 Schrader 2013 Thomsen Docetaxel Abiraterone 35 Docetaxel Abiraterone 24 Docetaxel Abiraterone PSA Response Abiraterone Therapy ( 50%) PSA Response ( 50%) Response to Therapy Median PFS Median OS 38.4% 12.8% 2.8 months Not reached 45.7% 28.6% months (mean) 58% (>30%) 58% (>30%) months Badrising 2013 Bournakis Docetaxel Abiraterone 25 Docetaxel Abiraterone or orteronel - 21% 12 weeks 8 ms 40% - -
13 ABIRATERONE: COU- AA- 302 pre- specified AEs of special interest: Endocrine Based Abiraterone + prednisone (n = 542) % Prednisone (n = 540) % All Grades Grade 3/4 All Grades Grade 3/4 Fluid reten%on/edema Hypokalemia Hypertension Cardiac disorders Atrial fibrilla%on ALT increased AST increased Fatigue 32 ALT, alanine aminotransferase; AST, aspartate aminotransferase. Ryan et al. Lancet Oncol. 2015;16(2):152-60
14 ENZALUTAMIDE PREVAIL: specific adverse events mainly CNS driven Adverse event All grades % Grade 3 events % (n=871) Placebo (n=844) (n=871) Placebo (n=844) Any cardiac event Atrial fibrilla%on 2 1 <1 1 Acute coronary syndromes Arterial Hypertension 1 <1 1 < Eleva%on in ALT 1 1 <1 <1 Seizure (<1) <1 <1 0 Falls 11.6% NA 1.4 NA Fatigue 35% *Seizure occurred after the data cutoff date ALT, alanine aminotransferase Beer et al. N Engl J Med Jul 31;371(5):424-33
15 Choosing Abiraterone vs enzalutamide Consider abiraterone Mild Baseline pain steroids may help Significant baseline fa%gue Polypharmacy Falls, gait or neurological issues Consider enzalutamide Diabetes Remote living Renal impairment Baseline Edema or CHF Keep in mind that the steroids with abiraterone are not supra-physiologic
16 Gerhardt Aaard UK Johann De Bono UK Rosalind A. Eeles UK Tomasz M. Beer US Himisha Beltran US Arul M. Chinnaiyan US Nicholas D. James UK Anwar Padhani UK Chris Parker UK Charles G. Drake US Eleni Efstathiou US Susan Halabi US Maha H.A. Hussain US Christopher J. Logothe1s US Peter Nelson US William K. Oh US Mark A. Rubin US Oliver A. Sartor US Howard I. Scher US Neal Shore US Eric Small US Maahew R. Smith US Christopher Sweeney US Frédéric Lecouvet BE Bertrand Tombal BE Jack A. Schalken NL Axel Heidenreich DE Sten Nilsson SE Gedske Daugaard DK Maria De San1s AT Stefano Fan1 IT Cora N. Sternberg IT Karim Fizazi FR David Olmos ES Ian Davis AU medical oncologist radia%on oncologist others Ian Tannock CA Hiroyoshi Suzuki JP 1st APCCC St Gallen Mee1ng What Do The Experts Say? Silke Gillessen CH urologist Hideyuki Akaza JP Avishay Sella IL Mar1n E. Gleave CA
17 24. Do you recommend abiraterone or enzalutamide as first- line therapy for otherwise healthy, asymptoma%c or minimally symptoma%c CRPC pa%ents in addi%on to ADT? ( i.e. PRIOR TO DOCETAXEL) 1- Yes, in the majority of pa%ents 78% 2- In a minority of selected pa%ents 6% 3- No 6% 4- Abstain 0% 5- Unqualified to answer 11% (%) 1 st APCCC St Gallen Meeting
18 First- line Treatment for M1 CRPC 25. Is it appropriate to extrapolate the results of PREVAIL (enzalutamide vs placebo in chemotherapy naïve CRPC pts) and COU- 302 (abiraterone + prednisone vs placebo + prednisone in chemotherapy naïve CRPC pts ) to symptoma1c chemotherapy naïve CRPC pa%ents? CONSENSUS 1- Yes 73% 2- No 22% 3- Abstain 0% 4- Unqualified to answer 5% (%) 1 st APCCC St Gallen Meeting
19 First- line Treatment for M1 CRPC 26. Is it appropriate to extrapolate the results of COU- 302 (abiraterone + prednisone vs placebo + prednisone in chemotherapy naïve CRPC pts without visceral metastases) to chemotherapy naïve CRPC pa%ents with visceral metastases? CONSENSUS 1- Yes 79% 2- No 11% 3- Abstain 0% 4- Unqualified to answer 11% (%) 1 st APCCC St Gallen Meeting
20 Complementary MOA enable combina%on Signaling Event Aberration Intervention Drugs Androgen Production Intracrine Production SCC Inhibitors CYP 17 Inihibitors Abiraterone Pre -Receptor Androgen Transport/ Circulation/ Uptake Polymorphisms Block Transport Conversion to DHT Amplified 5 Alpha Reductase 5-Alpha Reductase inhibitors Receptor AR Binding Amplified AR Splice Variant AR Novel AR Inhibitors
21 Combina%on Phase III: Alliance: A PI Michael Morris (accrued) Arm A: Arm B: Abiraterone Prednisone Stra%fica%on factor: prior chemo Total of 616 deaths, log- rank sta%s%c 90% power (one sided type I error rate of 0.025) to detect HR of 0.77 in favor of arm B
22 AR- V7: AR SPLICE VARIANT half AR Ac%vated without Binding Androgen CBP CRPC contains variants which lack LBD NTD DBD No current therapies can inhibit because they work through LBD Hinge LBD Antonarakis ES ASCO Annual Mee%ng. Abstract 5001.
23 AR- V7 and Resistance to and Abiraterone in CRPC PSA Responses According to AR- V7 Status -Treated Patients Best PSA Response, % change * * * AR-V7 positive AR-V7 negative Abiraterone-Treated Patients Best PSA Response, % change * * ** AR-V7 positive AR-V7 negative The dotted line shows the threshold for defining a PSA response ( 50% reduction in PSA level from baseline). *Increase seen of > 100% in best PSA response. Patients in the enzalutamide cohort who previously received abiraterone and patients in the abiraterone cohort who previously received enzalutamide. Antonarakis ES, et al. N Engl J Med. 2014;371:
24 Hopkins Study: Current Oral Therapies Lack Ac1vity in AR- V7+ Disease (cont d) Only 1 AR- V7 posi%ve pa%ent showed any PSA reduc%on AR- V7 prevalence increased post addi%onal treatments Response Treatment Baseline AR- V7+ AR- V7 status PSA50 P value rpfs P value OS (95% CI) P value Abiraterone 19% (N=31) (6/31) + 0% (0/6) 68% (17/25) mos >6.3 mos < mos (8.5 NR) NR (>18 mos) <0.001 (N=31) 39% (12/31) + 0% (0/12) 53% (10/19) mos 6.1 mos < mos (3.9 NR) < mos (14.2 NR) CI, confidence interval; rpfs, radiographic progression-free survival. Antonarakis E et al. AR- V7 and resistance to abiraterone and enzalutamide in prostate cancer. New Engl J Med;
25 Galeterone: Selective, Multi-targeted, Small Molecule for Treatment of CRPC CYP17 Lyase Inhibitor AR Antagonist AR Degrader Abiraterone Inhibits androgen synthesis Blocks androgen binding Decreases AR levels Galeterone No mandatory steroids Fasting not required Preclinical activity in mutation T878A Not a GABA A antagonist No seizures Preclinical activity in mutation F876L Active in C-terminal loss AR splice variants 25
26 ARMOR3- SV: First Precision Medicine Prostate Cancer Pivotal Trial Unique trial design finalized in consultadon with FDA and EMA Key Inclusion: Progressive metasta%c (M1) disease on androgen depriva%on therapy based on PCWG2 Detectable AR- V7 from CTCs ECOG 0 or 1 Key Exclusion: Prior treatment with second genera%on an%androgens (eg, abiraterone, enzalutamide) Prior treatment with chemotherapy for CRPC Randomize 1:1 N=148 Galeterone 2550 mg/day 160 mg/day Primary Endpoint: Radiographic progression free survival (rpfs) Secondary Endpoints: Time to cytotoxic therapy OS Taplin et al. Androgen Receptor Modula6on Op6mized for Response: Splice Variant (ARMOR3- SV); ASCO
27 TERRAIN: A Phase 2 Efficacy and Safety Study of vs Bicalutamide in mcrpc: Study Design 1 Patient population 375 men with progressive mcrpc Asymptomatic/ mildly symptomatic Chemotherapy-naïve Ongoing ADT No requirement for steroids Statistical design Final analysis planned at 220 progression events with 85% power to detect a target hazard ratio of 0.67 (assuming a median PFS of 9 months versus 6 months 2 ) Data cutoff date was 19 October 2014 with 240 events for the primary efficacy endpoint R A N D O M I Z E D 1:1 160 mg/day n = 184 Bicalutamide 50 mg/day n = 191 mcrpc = metastatic castration-resistant prostate cancer; PSA = prostate-specific antigen; SRE = skeletal-related event 1. Shore ND, et al. Lancet Oncol. 2016;17: Kucuk O, et al. Urology. 2001;58: Primary endpoint Progression-free survival (PFS), defined as time from randomization to (whichever occurs first): Radiographic progression SRE Initiation of new antineoplastic therapy Death Secondary endpoints PSA response Time to PSA progression Safety
28 TERRAIN: A Phase 2 Efficacy and Safety Study of vs Bicalutamide in mcrpc: Baseline Characteris%cs Pa1ent Characteris1cs ENZA (n = 184) BIC (n = 191) Median age, years ECOG performance score 0, n (%) 130 (70.7%) 146 (76.4%) Baseline pain 0-1 on BPI- SF Q3, n (%) 101 (54.9%) 117 (61.3%) Disease Characteris1cs ENZA (n = 184) BIC (n = 191) Gleason score 8 at ini%al diagnosis, n (%) 102 (55.4%) 110 (57.6%) PSA, median, ng/ml Alkaline phosphatase, median, U/L Bone disease only, n (%) 83 (45.1%) 92 (48.2%) Sot %ssue disease only, n (%) 36 (19.6%) 29 (15.2%) Bone and sot %ssue disease, n (%) 64 (34.8%) 69 (36.1%) BIC = bicalutamide; BPI-SF Q3, Brief Pain Inventory-Short Form question 3; ECOG, Eastern Cooperative Oncology Group; ENZA = enzalutamide; PSA = prostate-specific antigen; mcrpc = metastatic castration-resistant prostate cancer Shore ND, et al. Lancet Oncol. 2016;17:
29 TERRAIN: A Phase 2 Efficacy and Safety Study of vs Bicalutamide in mcrpc: Progression-Free Survival Patients without progression-free survival event, % ENZA Patients at risk Time (months) 184 Median 5.8 months (95% CI 4.8, 8.1) Median 15.7 months (95% CI 11.5, 19.4) ENZA BIC Hazard ratio 0.44 (95% CI 0.34, 0.57) p < BIC Patients at risk BIC = bicalutamide; CI = confidence interval; ENZA = enzalutamide; mcrpc = metastatic castration-resistant prostate cancer Shore ND, et al. Lancet Oncol. 2016;17:
30 TERRAIN: A Phase 2 Efficacy and Safety Study of vs Bicalutamide in mcrpc: Propor%ons of Pa%ents With Progression Events BIC = bicalutamide; ENZA = enzalutamide; mcrpc = metastatic castration-resistant prostate cancer Shore ND, et al. Lancet Oncol. 2016;17:
31 TERRAIN: A Phase 2 Efficacy and Safety Study of vs. Bicalutamide in mcrpc Radiographic Progression-Free Survival Radiographic progression-free survival (%) Median 16.4 months (95% CI 11.1, 18.1) Median NYR (95% CI 25.6, NYR) Hazard ratio 0.51 (95% CI 0.36, 0.74) p = Patients at risk ENZA BIC BIC = bicalutamide; CI = confidence interval; ENZA = enzalutamide; NYR = not yet reached; PSA = prostate-specific antigen Shore ND, et al. Lancet Oncol. 2016;17: FIELDMED-US-ENZA /16.
32 TERRAIN: A Phase 2 Efficacy and Safety Study of vs Bicalutamide in mcrpc Time to PSA Progression Patients without PSA progression event (%) ENZA Patients at risk ENZA BIC Time (months) 184 Median 5.8 months (95% CI 5.6, 8.3) Median 19.4 months (95% CI 16.6, NYR) Hazard ratio 0.28 (95% CI 0.20, 0.39) p < BIC Patients at risk BIC = bicalutamide; CI = confidence interval; ENZA = enzalutamide; mcrpc = metastatic castration-resistant prostate cancer; NYR = not yet reached; PSA = prostate-specific antigen Shore ND, et al. Lancet Oncol. 2016;17:
33 TERRAIN: A Phase 2 Efficacy and Safety Study of vs. Bicalutamide in mcrpc PSA Response by Week 13 >50% PSA decline 21% 82% >90% PSA decline 5% 56% BIC = bicalutamide; ENZA = enzalutamide; mcrpc = metastatic castration-resistant prostate cancer; PSA = prostate-specific antigen Heidenreich A, et al. EAU Congress. March 20 24, 2015; Madrid, Spain. Shore N, et al. AUA Congress. May 15 19, 2015; New Orleans, LA, USA. Presentation PII-LBA4. Shore ND, et al. Lancet Oncol Feb;17:
34 Impact of vs Bicalutamide on QoL in mcrpc: Results From the TERRAIN Study Summary of Changes in HRQoL From Baseline A decline in scores on all HRQoL domains was observed, except for FACT- P emo%onal well- being with enzalutamide At week 61, decline from baseline was smaller with enzalutamide than with bicalutamide Clinically relevant deteriora%on (exceeding the upper bound of MCID range) was seen with bicalutamide only (for 4 and 7 of 8 scores in the MMRM and PMM, respec%vely) Between- group comparison of changes from baseline at week 61 significantly favored enzalutamide on 2 FACT- P domains in the MMRM analysis and on 5 domains in the PMM analysis FACT-P = Functional Assessment of Cancer Therapy Prostate, HRQoL = health-related quality of life ; MCID = minimal clinically important difference; mcrpc = metastatic castration-resistant prostate cancer; MMRM = mixed-model repeated measures; PMM = pattern-mixture model; QoL = quality of life Heidenreich A, et al. European Cancer Congress; September 2015, Vienna, Austria. Poster P046. FIELDMED-US-ENZA /15.
35 TERRAIN: A Phase 2 Efficacy and Safety Study of vs Bicalutamide in mcrpc: Most Common Adverse Events ( 10%) Adverse event ENZA (n = 183) Grades 1-2 Grade 3 BIC (n = 189) ENZA (n = 183) BIC (n = 189) Fa%gue 27% 19% 1% 1% Back pain 16% 16% 3% 2% Hot flush 15% 11% 0% 0% Nausea 14% 17% 0% 0% Hypertension 7% 3% 7% 4% Cons%pa%on 11% 13% 1% 1% Diarrhea 11% 8% 0% 1% Weight decreased 10% 7% 1% 1% Pain in extremi%es 10% 5% 1% 1% Arthralgia 9% 15% 1% 1% BIC = bicalutamide; ENZA = enzalutamide; mcrpc = metastatic castration-resistant prostate cancer Shore ND, et al. Lancet Oncol. 2016;17:
36 Conclusions extended median PFS compared with bicalutamide by approximately 10 months prolonged the median %me to PSA progression compared to bicalutamide (19.4 vs 5.8 months) PSA response (decline 50%) was 82% in the enzalutamide arm compared to 21% in the bicalutamide arm Serious adverse events were reported in 31.1% of enzalutamide- treated pa%ents and 23.3% of bicalutamide- treated pa%ents Grade 3 or higher cardiac adverse events were reported in 5.5% of enzalutamide- treated pa%ents versus 2.1% of bicalutamide- treated pa%ents Most common adverse events occurring during treatment and more common in the enzalutamide- treated versus bicalutamide- treated pa%ents included fa%gue, hot flush, hypertension, diarrhea, weight decreased and pain in extremity demonstrated safety consistent with its known safety profile in pa%ents with mcrpc mcrpc = metastatic castration-resistant prostate cancer; PFS = progression-free survival; PSA = prostate-specific antigen Shore ND, et al. Lancet Oncol. 2016;17:
37 Select Compe%%ve AR Registra%on Trials* across the PC Disease Con%nuum Death PREVAIL TERRAIN ACIS* AFFIRM CO- 301 EMBARK* CO- 302 PSA ATLAS* PROSPER* ARCHES* TITAN* SPARTAN* LATITUDE* ARAMIS* Asymptomatic Non-Metastatic Metastatic Symptoms *Assuming FDA approval Castration Sensitive Time Castration Castration Resistant Resistant Abiraterone Apalutamide ODM-201
38 Thank You 38
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