Beschreibung:
<jats:p> 102^ </jats:p><jats:p> Background: ODM-201 is a novel potent full androgen receptor (AR) inhibitor for CRPC. ODM-201 has excellent nonclinical efficacy in xenograft studies and high PSA response rate in CYP17i-naïve CRPC patients in the phase I/II ARADES study. Methods: To further analyze clinical efficacy of ODM-201 in CRPC pts we evaluated the overall response rate (ORR) in ARADES phase I/II study (Fizazi et al. Abstract #2853, ECC2013, Amsterdam 28 Sept 2013 ).Patients (pts) were enrolled into three dose levels 100mg bid, 200mg bid and 700mg bid. Results: All eligible 124 pts had progressive mCRPC; 37 pts were pre-chemo/CYP17i-naïve, 32 post-chemo/CYP17i-naïve and 55 post-CYP17i. Thirty-two (86%) pts in the pre-chemo/CYP17i-naïve group, 27 (84%) post-chemo/CYP17i-naïve and 48 (87%) post-CYP17i had bone disease at baseline. Similarly, twenty-two (29%) pts, 19 (59%) and 36 (65%), respectively had RECIST-define measurable disease. Median baseline PSA was 101ng/mL (3-1294) in pre-chemo/CYP17-i-naïve group, 94ng/mL (8-663) in post-chemo/CYP17-i-naïve group, and 139ng/mL (9-5000) in post-CYP17i group. CTC count was over 5CTCs per 7.5ml in 43% of the pts in pre-chemo/CYP17-i-naïve group, 41% in post-chemo/CYP17-i-naïve group and 44% in postCYP17i group. ORR data is presented in table below. Conclusions: Although RECIST-define responses were observed across the 3 different group of pts treated with ODM-201 the vast majority of pts had RECIST-defined SD up to 12 weeks. These data are in line with PSA data reported previously that demonstrate the clinical activity of ODM-201 in men with mCRPC. Clinical trial information: NCT01317641, NCT01429064. [Table: see text] </jats:p>