Orteronel Plus Prednisone Fails to Improve Survival in Metastatic Castration-Resistant Prostate Cancer

the Cancer Therapy Advisor take:

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.