AUA 2016: Long-term safety and antitumor activity of ODM-201 in chemotherapy and CYP17-inhibitor naïve patients from the ARADES and the ARAFOR trials - Session Highlights

San Diego, CA USA ( Neal Shore, MD  presented the long-term safety and antitumor activity of ODM-201 in chemotherapy and CYP17-inhibitor naïve patients. Dr Neal Shore introduced ODM-201 as a new generation oral androgen receptor inhibitor that demonstrated tolerability and antineoplastic efficacy in metastatic castration resistant prostate cancer (mCRPC) patients.

The ARADES trial was an open, multicenter phase 1-2 trial examining the effects of ODM-201 in chemotherapy and novel anti-androgen naïve patients.

The trial was conducted in 23 centers in Europe and USA. The ARAFOR trial was an open, phase 1 trial that assessed the bioavailability of ODM-201. The trial was conducted in 14 centers in Europe. The authors reported the long-term safety and the antineoplastic activity of ODM-201 in chemotherapy- and CYP17-inhibitor-naive patients evaluated in these 2 trials.

41 patients with progressive mCRPC who were naive to chemotherapy and CYP17-inhibitor treatment received between 600 mg to 900 mg of ODM-201 twice daily. Median follow-up time in the studies was 13.5 months. Age ranged from 54 years to 86 years. 100% of the patients had an ECOG score of 0-1. PSA ranged from 3.5 to 1294 ng/mL with a median of 28 ng/mL. The median time from prostate cancer diagnosis to start of the ODM-201 treatment was 4 years 2 months, and prior LHRH therapy to trial enrollement was 1 year and 11 months. AEs were common with 80% of patients developing at least 1 AE. Grade 3, 4 and 5 AE's occurred in 10, 2 and 1 patients respectively. Treatment-related AEs occurred in 10 (24%) patients; all were grade 1. The most common treatment-related AEs were fatigue (3; 7%) and hot flushes (2; 5%).

Median time to PSA progression by Prostate Cancer Working Group (PCWG2) criterion was 54 weeks (95% CI 27-79).

The authors conclude that ODM-201 daily doses between 600-900mg bid has encouraging antitumor activity, and the safety profile remained favorable in patients with mCRPC who were naive for chemotherapy and CYP17-inhibitor treatment.


Presented By: Neal Shore, MD.

Written By: Miki Haifler MD. Fox Chase Cancer Center, Philadelphia, PA. at the 2016 AUA Annual Meeting - May 6 - 10, 2016 – San Diego, California, USA