ODM-201: A new-generation androgen receptor inhibitor in castration-resistant prostate cancer

Expert Review of Anticancer Therapy

Volumn 15, Issue 9, 2015, Pages 1007-1017

  Fizazi, Karim ^a   Albiges, Laurence ^a   Loriot, Yohann ^a   Massard, Christophe ^a  

^a INSTITUT GUSTAVE ROUSSY   (France)

Author keywords

androgen receptor inhibitors; castration resistant; efficacy; metastatic; non metastatic; ODM 201; pharmacodynamics; pharmacokinetics; prostate cancer; tolerability

Indexed keywords

ABIRATERONE ACETATE; ANDROGEN RECEPTOR; ANDROGEN RECEPTOR ANTAGONIST; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; APALUTAMIDE; CYTOCHROME P450 1A2; CYTOCHROME P450 2A6; CYTOCHROME P450 2B6; CYTOCHROME P450 2C19; CYTOCHROME P450 2C8; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; DRUG METABOLITE; ENZALUTAMIDE; ODM 201; ORM 15341; PLACEBO; PROSTATE SPECIFIC ANTIGEN; UNCLASSIFIED DRUG; ORM-16497; PHENYLTHIOHYDANTOIN; PYRAZOLE DERIVATIVE;

ANTIANDROGEN THERAPY; ANTINEOPLASTIC ACTIVITY; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BONE SCINTISCANNING; CANCER SURVIVAL; CASTRATION RESISTANT PROSTATE CANCER; CONSTIPATION; DECREASED APPETITE; DIARRHEA; DOSE RESPONSE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG HALF LIFE; DRUG METABOLISM; DRUG PENETRATION; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG STRUCTURE; DRUG SYNTHESIS; DRUG TOLERABILITY; FATIGUE; FOOD DRUG INTERACTION; HEADACHE; HOT FLUSH; HUMAN; MAXIMUM PLASMA CONCENTRATION; METASTATIC CASTRATION RESISTANT PROSTATE CANCER; MULTICENTER STUDY (TOPIC); NAUSEA; NONHUMAN; OVERALL SURVIVAL; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); SEIZURE; SIGNAL TRANSDUCTION; STEADY STATE; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; TUMOR XENOGRAFT; URINE INCONTINENCE; ANALOGS AND DERIVATIVES; ANIMAL; CHEMISTRY; DRUG DESIGN; MALE; PATHOLOGY; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; SURVIVAL RATE;

ABIRATERONE ACETATE; ANDROGEN RECEPTOR ANTAGONISTS; ANIMALS; DRUG DESIGN; HUMANS; MALE; PHENYLTHIOHYDANTOIN; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; PYRAZOLES; SURVIVAL RATE;

EID: 84940496756     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/14737140.2015.1081566     Document Type: Article

References (69)

1. Massard C, Fizazi K. Targeting continued androgen receptor signalling in prostate cancer. Clin Cancer Res 2011;17:3876-83
2. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 2, 2014. Available from: www.nccn.org/professionals/physician-gls/f-guidelines.asp [Last accessed 11 September 2014]
3. Horwich A, Hugosson J, de Reijke T, et al. Prostate cancer: ESMO Consensus Conference Guidelines 2012. Ann Oncol 2013;24:1141-62
4. Montgomery RB, Mostaghel EA, Vessella R, et al. Maintenance of intratumoral androgens in metastatic prostate cancer: a mechanism for castration-resistant tumor growth. Cancer Res 2008;68:4447-54
5. Stanbrough M, Bubley GJ, Ross K, et al. Increased expression of genes converting adrenal androgens to testosterone in androgen-independent prostate cancer. Cancer Res 2006;66:2815-25
6. Antonarakis ES, Nakazawa M, Luo J. Resistance to androgen-pathway drugs in prostate cancer. N Engl J Med 2014;371: 1028-38
7. Shafi AA, Yen AE, Weigel NL. Androgen receptors in hormone-dependent and castration-resistant prostate cancer. Pharmacol Ther 2013;140:223-38
8. Mostaghel EA, Marck BT, Plymate SR, et al. Resistance to CYP17A1 inhibition with abiraterone in castration-resistant prostate cancer: induction of steroidogenesis and androgen receptor splice variants. Clin Cancer Res 2011;17:5913-25
9. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011;364:1995-2005
10. Fizazi K, Scher HI, Molina A, et al. COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol 2012;13:983-92
11. Scher HI, Fizazi K, Saad F, et al. AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 2012;367: 1187-97
12. Beer TM, Armstrong AJ, Rathkopf DE, et al. PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med 2014;371: 424-33
13. Ryan CJ, Smith MR, Fizazi K, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COUAA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol 2015;16:152-60
14. Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010;363:411-22
15. de Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 2010;376:1147-54
16. Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 2013;369:213-23
17. Fizazi K, Carducci M, Smith M, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet 2011;377:813-22
18. Amgen. Open-label access protocol of denosumab for subjects with advanced cancer. Available from: http://clinicaltrials. gov/show/NCT01419717
19. Northwestern University. Zolendronate for the prevention of bone loss in men w/prostate CA on long-term androgen deprivation. Available from: http://clinicaltrials.gov/show/NCT00058188
20. Janssen Research & Development. Study of abiraterone acetate in patients with advanced prostate cancer. Available from: http://clinicaltrials.gov/show/NCT01217697
21. Spanish Oncology Genito-Urinary Group. Study of weekly cabazitaxel for advanced prostate cancer. Available from: http://clinicaltrials.gov/show/NCT01518283
22. Bayer. Radium(223) dichloride (alpharadin) in castration-resistant (hormone-refractory) prostate cancer patients with bone metastases. Available from: http://clinicaltrials.gov/show/NCT01618370
23. Joseph JD, Lu N, Qian J, et al. A clinically relevant androgen receptor mutation confers resistance to second-generation antiandrogens enzalutamide and ARN-509. Cancer Discov 2013;3:1020-9
24. Clegg NJ, Wongvipat J, Joseph JD, et al. ARN-509: a novel antiandrogen for prostate cancer treatment. Cancer Res 2012;72: 1494-503
25. Moilanen A, Riikonen R, Oksala R, et al. Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signalling-directed prostate cancer therapies. Sci Rep 2015;5:12007
26. Fizazi K, Massard C, Bono P, et al. ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol 2014;15:975-85
27. Massard C, Tammela TLJ, Vjaters E, et al. A study of two ODM-201 formulations with a safety and tolerability extension phase in patients with metastatic chemotherapy-naive castration-resistant prostate cancer (CRPC). J Clin Oncol 2014.32(Suppl 4):abstr 115. Available from: www.orion.fi/globalassets/documents/rd/congress-posters/asco-gu-poster-massard-etal-2014.pdf?id=955&epslanguage=en
28. Moilanen A, Riikonen R, Oksala R, et al. ODM-201-new generation antiandrogen with excellent antiandrogenic and antitumor activity in nonclinical models of CRPC. Eur J Cancer 2013;49(Suppl 2): abstr 2869
29. Scher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the prostate cancer clinical trials working group. J Clin Oncol 2008;26:1148-59
30. Massard C, Penttinen H, Bono P, et al. Pharmacokinetics, activity, and safety of ODM-201 in chemotherapy-nave patients with metastatic castration-resistant prostate cancer: An open-label phase I trial with long-term extension. J Clin Oncol 2015; 33(Suppl 7):abstr 230
31. Tammela L, Massard C, Bono P, et al. European Urology Supplements. Safety and efficacy of ODM-201 in chemotherapy and CYP17-inhibitor nave patients: Analysis of data from the ARADES and the ARAFOR trials (abstract 862). Presented at the 29th Annual European Association of Urology Congress, Stockholm, Sweden, 2014. Available from: www.urotoday.com/Prostate-Cancer/eau-2014-poster-safety-and-efficacyof-odm-201-in-chemotherapy-and-cyp17-inhibitor-naive-patients-analysis-of-datafrom-the-arades-and-the-arafor-trials.html
32. Shore ND, Bono P, Massard C, et al. ODM-201 and the central nervous system-A clinical perspective. J Clin Oncol 2014; 32(Suppl 4):abstr 275. Available from: http://meetinglibrary.asco.org/content/90517?media=vm
33. Tombal B. Non-metastatic CRPC and asymptomatic metastatic CRPC: which treatment for which patient? Ann Oncol 2012;23(Suppl 10):x251-8
34. Nelson JB, Love W, Chin JL, et al. Phase 3, randomized, controlled trial of atrasentan in patients with 13nonmetastatic, hormone-refractory prostate cancer. Cancer 2008;113:2478-87
35. Smith MR, Kabbinavar F, Saad F, et al. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. J Clin Oncol 2005;23:2918-25
36. See comment in PubMed Commons below. Miller K, Moul JW, Gleave M, et al. Phase III, randomized, placebo-controlled study of once-daily oral zibotentan (ZD4054) in patients with non-metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis 2013;16:187-92
37. Smith MR, Saad F, Oudard S, et al. Denosumab and bone metastasis-free survival in men with nonmetastatic castration-resistant prostate cancer: exploratory analyses by baseline prostate-specific antigen doubling time. J Clin Oncol 2013;31:3800-6
38. Anon. Efficacy and safety study of ODM-201 in men with high-risk nonmetastatic castration-resistant prostate cancer (ARAMIS). Available from: http://clinicaltrials.gov/ct2/show/NCT02200614
39. Korpal M, Korn JM, Gao X, et al. An F876L mutation in androgen receptor confers genetic and phenotypic resistance to MDV3100 (enzalutamide). Cancer Discov 2013;3:1030-43
40. Danila DC, Morris MJ, de Bono JS, et al. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castration-resistant prostate cancer. J Clin Oncol 2010;28: 1496-501
41. Scher HI, Beer TM, Higano CS, et al. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet 2010;375: 1437-46
42. Saad F, de Bono J, Shore N, et al. Efficacy outcomes by baseline prostate-specific antigen quartile in the AFFIRM trial. Eur Urol 2015;67:223-30
43. Rathkopf DE, Morris MJ, et al. Phase I study of ARN-509, a novel antiandrogen, in the treatment of castration-resistant prostate cancer. J Clin Oncol 2013;31:3525-30
44. Foster WR, Car BD, Shi H, et al. Drug safety is a barrier to the discovery and development of new androgen receptor antagonists. Prostate 2011;71:480-8
45. Hussain M, Corn PG, Michaelson MD, et al. Prostate Cancer Clinical Trials Consortium, a program of the Department of Defense Prostate Cancer Research Program and the Prostate Cancer Foundation. Phase II study of single-agent orteronel (TAK-700) in patients with nonmetastatic castration-resistant prostate cancer and rising prostate-specific antigen. Clin Cancer Res 2014;20:4218-27
46. Saad F, Fizazi K, Jinga V, et al. Orteronel plus prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (ELM-PC 4): a double-blind, multicentre, phase 3, randomised, placebo-controlled trial. Lancet Oncol 2015;16:338-48
47. Fizazi K, Jones R, Oudard S, et al. Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5 J Clin Oncol 2015;33: 7273-31
48. Anon. Safety and efficacy study of enzalutamide in patients with non-metastatic castration-resistant prostate cancer (PROSPER). Available from: http://clinicaltrials.gov/ct2/show/NCT02003924
49. Anon. A study of ARN-509 in men with non-metastatic castration-resistant prostate cancer (SPARTAN). Available from: http://clinicaltrials.gov/ct2/show/NCT01946204
50. Sweeney C, Chen Y-H, Carducci MA, et al. Impact on overall survival (OS) with chemohormonal therapy versus hormonal therapy for hormone-sensitive newly metastatic prostate cancer (mPrCa): An ECOG-led phase III randomized trial. J Clin Oncol 2014;32:5s; Suppl; abstr LBA2
51. Gravis G, Fizazi K, Joly F, et al. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol 2013;14:149-58
52. Loriot Y, Bianchini D, Ileana E, et al. Antitumour activity of abiraterone acetate against metastatic castration-resistant prostate cancer progressing after docetaxel and enzalutamide (MDV3100). Ann Oncol 2013;24:1807-12
53. Mezynski J, Pezaro C, Bianchini D, et al. Antitumour activity of docetaxel following treatment with the CYP17A1 inhibitor abiraterone: clinical evidence for crossresistance? Ann Oncol 2012;23:2943-7
54. de Bono JS, Smith MR, Saad F, et al. Response to taxane chemotherapy as first subsequent therapy after abiraterone acetate (AA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Post-hoc analysis of COU-AA-302. J Clin Oncol 2015; 33(Suppl 7):abstr 184
55. Noonan KL, North S, Bitting RL, et al. Clinical activity of abiraterone acetate in patients with metastatic castration-resistant prostate cancer progressing after enzalutamide. Ann Oncol 2013;24:1802-7
56. Schweizer MT, Zhou XC, Wang H, et al. The influence of prior abiraterone treatment on the clinical activity of docetaxel in men with metastatic castration-resistant prostate cancer. Eur Urol 2014;66:646-52
57. Al Nakouzi N, Le Moulec S, Albige's L, et al. Cabazitaxel remains active in patients progressing after docetaxel followed by novel androgen receptor pathway targeted therapies. Eur Urol 2014;68(2):228-35
58. Anon. Sequencing abiraterone and enzalutamide in mCRPC. Available from: http://clinicaltrials.gov/ct2/show/NCT02125357
59. Anon. A registry to observe the treatment of prostate cancer under routine medical care. Available from: http://clinicaltrials.gov/ct2/show/NCT02236637
60. Anon. Enzalutamide with or without abiraterone acetate and prednisone in treating patients with castration-resistant metastatic prostate cancer. Available from: http://clinicaltrials.gov/ct2/show/NCT01949337
61. Anon. Radium-223 dichloride and abiraterone acetate compared to placebo and abiraterone acetate for men with cancer of the prostate when medical or surgical castration does not work and when the cancer has spread to the bone, has not been treated with chemotherapy and is causing no or only mild symptoms (ERA 223). Available from: http://clinicaltrials.gov/ct2/show/NCT02043678
62. Anon. Phase III Radium 223 mCRPC-PEACE III. Available from: http://clinicaltrials.gov/ct2/show/NCT02194842
63. Anon. Abiraterone acetate with or without LHRH-therapy in men with progressive chemotherapy-nave CRPC. Available from: https://clinicaltrials.gov/ct2/show/NCT02077634
64. Fizazi K, Abrahamsson PA, Ahlgren G, et al. Achievements and perspectives in prostate cancer phase 3 trials from genitourinary research groups in Europe: introducing the prostate cancer consortium in Europe. Eur Urol 2014;67:904-12
65. Ryan CJ, Molina A, Li J, et al. Serum androgens as prognostic biomarkers in castration-resistant prostate cancer: results from an analysis of a randomized phase III trial. J Clin Oncol 2013;31:2791-8
66. Attard G, de Bono JS, Logothetis CJ, et al. Improvements in radiographic progression-free survival stratified by ERG gene status in metastatic castration-resistant prostate cancer patients treated with abiraterone acetate. Clin Cancer Res 2015;21:1621-7
67. Morris MJ, Molina A, Small EJ, et al. Radiographic progression-free survival as a response biomarker in metastatic castration-resistant prostate cancer: COU-AA-302 results. J Clin Oncol 2015;33:1356
68. Danila DC, Fleisher M, Scher HI. Circulating tumor cells as biomarkers in prostate cancer. Clin Cancer Res 2011;17: 3903-12
69. Gillessen S, Omlin A, Attard G, et al. Management of patients with advanced prostate cancer: Recommendations of the St. Gallen Advanced Prostate Cancer Consensus Conference (APCCC). Ann Oncol 2015;In Press