Takeda's Prostrate Cancer Drug Improves Patient Survival
Takeda Pharmaceutical announced that data from its Phase III trial in investigational drug orteronel plus prednisone showed that the treatment improved progression free survival (PFS) in patients with chemotherapy-naïve metastatic castration resistant prostate cancer.
The international, pivotal, randomized, double blind Phase 3 trial ELM-PC4 (Evaluation of the Lyase inhibitor orteronel in Metastatic Prostate Cancer 4) compared orteronel plus prednisone to placebo plus prednisone in 1,560 male patients. The combo treatment reduced risk of radiographic progression free survival (rPFS) by 30 percent compared to placebo plus prednisone.
Second primary endpoint of overall survival (OS) also showed improvement in median OS, though the improvement was not as statistically significant.
Prostate cancer remains the most common cancer in American men aside from skin cancer. According to the American Cancer Society, about 233,000 new cases of prostate cancer will be diagnosed in 2014. Approximately 29,480 patients will die from the disease this year.
Orteronel is an investigational oral, non-steroidal, selective 17,20-lyase inhibitor discovered by Takeda. 17,20-lyase is a key enzyme in steroidal hormones production, including androgens. Research shows that synthesis of androgens outside the testes leads to the progression of disease castration-resistant prostate cancer (CRPC).
“The significant rPFS advantage observed for orteronel combined with prednisone in the ELM-PC4 study is consistent with the previously reported rPFS improvement observed in the ELM-PC5 study, where orteronel was also studied with prednisone in men with mCRPC who had previously received chemotherapy,” said Michael Vasconcelles, Global Head of Takeda Oncology Therapeutic Area Unit. Vasconcelles said the company is subjecting the data under close examination and analysis to guide future steps in the orteronel program. He also thanked the patients and investigators involved in the clinical trial.
The company said it will present study results at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) this year.