The Takeda Oncology Company with its parent company Takeda
Pharmaceutical Company Limited (TSE:4502) today announced updated
results from a phase 2 study of orteronel, a selective oral 17,20 lyase
inhibitor, dosed without prednisone in patients with non-metastatic
castration resistant prostate cancer (nmCRPC) and rising
prostate-specific antigen (PSA). These data were presented in a poster
discussion session at the annual meeting of the American Society of
Clinical Oncology (ASCO), held June 1-5 in Chicago, Illinois.
"Non-metastatic castration resistant prostate cancer is an area of unmet
need, and therapies that reduce PSA without the need for concomitant
corticosteroids are of particular interest in these earlier lines of
prostate cancer treatment," said Daniel George, M.D., Duke University
"We are encouraged by the results with orteronel in non-metastatic
prostate cancer," said Karen Ferrante, M.D., Chief Medical Officer,
Millennium. "These data support the continued evaluation of orteronel in
a steroid free regimen."
Safety and activity of the investigational agent TAK-700 (orteronel)
without prednisone in men with nonmetastatic castration-resistant
prostate cancer (nmCRPC) and rising prostate-specific antigen (PSA):
Updated results of a phase 2 study (Abstract #4549)
The primary objective of this study was to determine the percentage of
patients achieving a PSA reduction to ≤ 0.2 ng/mL (undetectable levels).
Patients with PSA values of 0.2ng/mL or less have been shown to have a
greater survival advantage. Secondary objectives were to
determine the safety of orteronel, PSA response rates at 3 months and 6
months (decline in PSA of ≥ 90 percent, ≥ 50 percent and/or ≥ 30
percent), the percentage of patients achieving a PSA reduction to ≤ 0.2
ng/mL after 6 months, time to PSA progression, time to metastases,
duration of progression-free survival, and changes in endocrine markers.
Results from the study of 39 patients, which were presented by Dr.