According to a new study published in the journal The Lancet Oncology, researchers have found that the combination of orteronel and prednisone improved progression-free survival, but not overall survival, in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC) compared with placebo plus prednisone.
For this double-blind, placebo-controlled, phase 3 study, researchers enrolled 1,560 patients with chemotherapy-naive mCRPC and randomly assigned them 1:1 to receive either orteronel 400mg plus prednisone 5mg twice daily or placebo plus prednisone 5mg twice daily.
Results showed that with a median follow-up of 8.4 months, the median radiographic progression-free survival was 13.8 months (95% CI: 13.1 - 14.9) and 8.7 months (8.3 - 10.9) with orteronel and prednisone, respectively (HR = 0.71; 95% CI: 0.63 - 0.80; P < 0.0001). In addition, with a median follow-up of 20.7 months, the median overall survival was 31.4 months (95% CI: 28.6 - NE) with orteronel compared with 29.5 months (27.0 - NE) with placebo (HR = 0.92; 95% CI: 0.79 - 1.08; P = 0.31).
Orteronel plus prednisone was also associated with increased toxicity versus placebo prednisone. The negative findings have led to the discontinuation of development of orteronel for mCRPC.
The authors assessed orteronel in chemotherapy-naive patients with metastatic castration-resistant prostate cancer. In chemotherapy-naive patients with metastatic castration-resistant prostate cancer, radiographic progression-free survival was prolonged with orteronel plus prednisone versus placebo plus prednisone.