158284-172
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`A randomized trial of abiraterone acetate (AA) administered with 1 of 4 glucocorticoid (GC)
`regimens in metastatic castration-resistant prostate cancer (mCRPC) patients (pts).
`
`Meeting:
`2016 Genitourinary Cancers Symposium
`
`Category:
`Genitourinary Cancer
`
`Subcategory:
`Prostate Cancer - Advanced Disease
`
`Session Type and Session Title:
`Poster Session A: Prostate Cancer
`
`Abstract Number:
`261
`
`Citation:
`J Clin Oncol 34, 2016 (suppl 2S; abstr 261)
`
`Author(s):
`Gerhardt Attard, Axel S. Merseburger, Cora N. Sternberg, Linda Cerbone, Federica Recine, Robert J.
`Jones, Susan Feyerabend, Alfredo Berruti, Steven Joniau, Peter Schatteman, Lajos Geczi, Peter
`Tenke, Patrick Werbrouck, Florence Lefresne, Florence Nave Shelby, Marjolein Lahaye, Corinna
`Pick, Bertrand F. Tombal; The Institute of Cancer Research and The Royal Marsden Hospital,
`London, United Kingdom; Department of Urology, University of Lübeck, Lübeck, Germany;
`Department of Medical Oncology, San Camillo and Forlanini Hospital, Rome, Italy; University of
`Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; Studienpraxis
`Urologie, Nürtingen, Germany; Medical Oncology, University of Brescia, Spedali Civili Hospital,
`Brescia, Italy; University Hospitals Leuven, Leuven, Belgium; Onze-Lieve-Vrouwziekenhuis, Aalst,
`Belgium; Chemotherapy C and Clinical Pharmacology Department, National Institute of Oncology,
`Budapest, Hungary; Jahn Ferenc Dél-Pesti Kórház, Urology Department, Budapest, Hungary; AZ
`Groeninge, Kortrijk, Belgium; Janssen-Cilag, Paris, France; Janssen-Cilag, Tilburg, Netherlands;
`Janssen-Cilag, Neuss, Germany; Institut de Recherche Expérimental et Clinique, Université
`Catholique de Louvain, Brussels, Belgium
`
`Background: AA is approved for mCRPC, coadministered with prednisone (P) (5 mg BID) to
`prevent adverse events (AEs) associated with mineralocorticoid excess (ME). Lower GC doses had
`not previously been formally evaluated in combination with AA. Methods: This was an open-label,
`multicenter, phase 2 trial (NCT01867710) of asymptomatic chemotherapy-naïve mCRPC pts
`randomized 1:1:1:1 to AA (1000 mg QD) plus P 5 mg BID or P 5 mg QD or P 2.5 mg BID or
`dexamethasone (DEX) 0.5 mg QD. Pts who had previously received GC or ketoconazole were
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`http://meetinglibrary.asco.org/print/2131916
`
`4/6/2017
`
`WCK1094
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
`
`1
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`158284-172
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`Page 2 of 2
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`excluded. The primary end point was no ME (% of pts experiencing neither hypokalemia nor
`hypertension during the first 24 weeks of treatment).Secondary end points included additional safety,
`as well as response rate in the first 24 weeks, defined as a decline in prostate-specific antigen (PSA) ≥
`50% confirmed after 4 weeks. Results: 164 pts were randomized; 133 (81.6%) completed 24 weeks’
`treatment. Median age: 70 years. Table 1 shows the rates of ME, hypertension, hypokalemia and PSA
`response. Changes in HbA1c values were minimal and observed in 16 (10.7%) pts. Conclusions:
`These data suggest that P 5 mg BID, which is approved in combination with AA, and DEX 0.5 mg
`QD, are effective in preventing ME-associated AEs, and that P 2.5 mg BID and P 5 mg QD can be
`safely used with appropriate monitoring. The suggestion of a higher PSA response rate with DEX 0.5
`mg QD arm warrants further validation. Clinical trial information: NCT01867710
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`P 5 mg BID
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`P 5 mg QD
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`P 2.5 mg BID
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`DEX 0.5 mg QD
`
`n = 41
`
`n = 41
`
`n = 40
`
`n = 42
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`27/34 (79.4)
`
`17/37 (45.9)
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`22/35 (62.9)
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`28/37 (75.7)
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`No MEa, n/N (%)
`Hypokalemiaa, n/N (%)
`Overall
` Grade 3
`Hypertensiona, n/N (%)
`Overall
` Grade 3
`≥ 50% PSA response at
`Week 12, n/N (%)
`35/39 (89.7)
`37/37 (100)
`34/36 (94.4)
`28/38 (73.7)
`No change in HbA1c, n/N (%)b
`N = Evaluable pts. aAccording to the National Cancer Institute Common Terminology Criteria for
`Adverse Events V4.0. No grade 4 occurred. bChange at end point versus baseline.
`
`3/41 (7.3)
`0
`
`6/41 (14.6)
`2/41 (4.9)
`
`3/39 (7.7)
`0
`
`4/42 (9.5)
`0
`
`6/41 (14.6)
`3/41 (7.3)
`20/35 (57.1)
`
`15/41 (36.6)
`6/41 (14.6)
`24/34 (70.6)
`
`12/39 (30.8)
`5/39 (12.8)
`17/37 (45.9)
`
`5/42 (11.9)
`1/42 (2.4)
`31/39 (79.5)
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`Source URL: http://meetinglibrary.asco.org/content/158284-172
`
`http://meetinglibrary.asco.org/print/2131916
`
`4/6/2017
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