Phase 2 Study Update of Orteronel for non-Metastatic Castration-Resistant Prostate Cancer
Millennium Pharmaceuticals announced updated results from a Phase 2 study of Orteronel (TAK-700) dosed without prednisone for non-metastatic castration-resistant prostate cancer (nmCRPC) and rising prostate-specific antigen (PSA).
The primary objective of this study (n=39) was to determine the percentage of patients achieving a PSA reduction to ≤0.2ng/mL (undetectable levels). Starting dose of TAK-700 was 300mg twice daily and continued until PSA progression, metastases, or unacceptable toxicity. Study results showed that 16% of patients experienced PSA <0.2ng/mL at three months, and 12 (32%) experienced PSA <0.2ng/mL as their best response. Median time to PSA progression was 14.8 months.
Eligible patients had nmCRPC with PSA ≥2ng/mL (PSA ≥8ng/mL if doubling time >8 months), and surgical/medical castration, with testosterone (T) <50ng/dL. Prior chemotherapy or ketoconazole, and concomitant corticosteroids were excluded.
For more information call (800) 589-9005 or visit www.millennium.com.