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`Cabazitaxel vs docetaxel in chemotherapy-naive (CN) patients with metastatic castration-resistant prostate
`cancer (mCRPC): A three-arm phase III study (FIRSTANA).
`
`Meeting:
`2016 ASCO Annual Meeting
`
`Category:
`Genitourinary (Prostate) Cancer
`
`Subcategory:
`Advanced Disease
`
`Session Type and Session Title:
`Oral Abstract Session, Genitourinary (Prostate) Cancer
`
`Abstract Number:
`5006
`
`Citation:
`
`J Clin Oncol 34, 2016 (suppl; abstr 5006)
`
`Author(s):
`A. Oliver Sartor, Stephane Oudard, Lisa Sengelov, Gedske Daugaard, Fred Saad, Steinbjoern Hansen, Marie
`Hjelm-Eriksson, Jacek Jassem, Antoine Thiery-Vuillemin, Orazio Caffo, Daniel E. Castellano, Paul N.
`Mainwaring, John P Bernard, Liji Shen, Mustapha Chadjaa, Karim Fizazi; Tulane University, New Orleans, LA;
`Department of Medical Oncology, Hopital Européen Georges Pompidou, Paris, France; Department of
`Oncology, Herlev, Denmark; Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark;
`University of Montreal, Montreal, QC, Canada; ODENSE UNIVERSITY HOSPITAL, Odense, Denmark;
`Department of Oncology, Karolinska Institute, Stockholm, Sweden; Medical University of Gdansk, Gdansk,
`Poland; Jean Minj oz Hospital, Besancon, France; Medical Oncology, Santa Chiara Hospital, Trento, Trento,
`Italy; Hospital Universitario 12 de Octubre, Madrid, Spain; ICON Cancer Care, South Brisbane, Australia;
`Sanofi, Cambridge, MA; Sanofi, Bridgewater, NJ; Sanofi, Paris, France; Institut Gustave Roussy, University of
`Paris Sud, Villejuif, France
`
`Background: The Phase III TROPIC study (NCTOO417079) reported significant improvement in overall
`survival (OS) for cabazitaxel 25 mg/m2IV Q3W plus prednisone 10 mg PO QD (P) vs. mitoxantrone plus P in
`mCRPC pts previously treated with a docetaxel (D)-containing regimen. The FIRSTANA study examined if
`cabazitaxel 20 mg/m2 (C20) or 25 mg/ml (C25) IV Q3W plus P is superior to docetaxel 75 mg/m2 (D75) IV
`Q3W plus P in terms of OS in CN mCRPC pts. Methods: In this multinational, open label phase III study,
`mCRPC pts, ECOG PS 0-2, who had progressed after castration were randomized 1:1 :1 to C20, C25 or D75 IV
`Q3W plus P. The primary endpoint was OS. Key secondary endpoints were safety, progression free survival
`(PFS), tumor PFS, tumor response (RECIST 1.1), PSA response, PSA PFS, pain response, pain PFS, time to
`skeletal-related events (SRE) and health-related quality of life (HRQOL). Results: Between May 2011 and
`April 2013, 1168 pts were randomized (C20=391, C25=3 89, D75=388). Baseline demographics and disease
`characteristics were similar across cohorts. The median number of treatment cycles was 9 for all dose groups. In
`the ITT analysis, median OS was 24.5 months for C20, 25.2 months for C25 and 24.3 months for D75. HR for
`C20 vs. D75 was 1.009 (0.85 to 1.197, p=0.9967) and for C25 vs. D75 was 0.97 (0.819 to 1.16, p=0.7574),
`indicating that C20 and C25 were not superior to D75 in terms of OS. PFS was 4.4 months for C20, 5.1 months
`http://m eetinglibrary.asco.orgIprint/2395201
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`AVENTIS EXHIBIT 2212
`Mylan v. Aventis IPR2016-00712
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`

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`12/20/2016
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`166318-176
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`for C25 and 5.3 months for D75 (NS). Tumor responses were superior in C25 (41.6%) compared to D7 5
`(30.9%), p=0.0370. Other secondary endpoints did not significantly differ across dose groups. Adverse events
`(AEs) grade 3-4 were 41.2% in C20, 60.1% in C25 and 46.0% in D75; pts discontinuing treatment due to an AE
`were 25.2% in C20, 31.7% in C25 and 33.9% in D75. Febrile neutropenia, diarrhea and hematuria were more
`frequent in C25; peripheral neuropathy, peripheral edema, alopecia and nail disorders were more frequent in
`D75. Conclusions: C20 and C25 did not demonstrate superiority for OS compared to D75 in CN mCRPC pts.
`Among secondary endpoints only tumor responses were significantly superior for C25. AEs were less frequent
`in C20 for most categories. Clinical trial information: NCT0l308567
`
`Source URL: http://meetinglibrary.asco.org/content/ l 663 18-176
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`http://m eetinglibrary.asco.org/print/2395201
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