Orteronel Plus Prednisone Improved Progression Free Survival in Men With Chemotherapy-Naïve Metastatic Castration Resistant Prostate Cancer in Phase 3 Study

Osaka, Japan, May 16, 2014 –Takeda Pharmaceutical Company Limited (TSE:4502) today announced data from ELM-PC4, a pivotal, international, double blind, randomized Phase 3 trial showing that the investigational drug orteronel plus prednisone reduced the risk of radiographic progression free survival (rPFS), one of the study’s two primary endpoints, by 30 percent compared to placebo plus prednisone in men with chemotherapy-naïve metastatic castration resistant prostate cancer (mCRPC) [median rPFS 11.0 vs. 8.3 months (HR 0.7; 95% CI:0.5-0.8; P < 0.001)]. The second primary endpoint, overall survival (OS), showed a numerical improvement in median OS of 1.9 months that was not statistically significant [median OS: 31.4 vs. 29.5 months (HR 0.9; 95% CI: 0.8-1.1; P=0.314)]. Results from the study will be presented as an oral presentation on June 1 during the Genitourinary (Prostate) Cancer session at the annual meeting of the American Society of Clinical Oncology (ASCO).

“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. We are carefully analyzing these data to fully inform future decisions in the orteronel program,” said Michael Vasconcelles, M.D., Global Head, Takeda Oncology Therapeutic Area Unit. “We thank and express our gratitude to the patients, their families and the study investigators for their significant contributions to the orteronel program to date.”

The abstract, titled “Phase 3, randomized, placebo-controlled trial of orteronel (TAK-700) plus prednisone in patients (pts) with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) (ELM-PC 4 trial) [Abstract #5008]”, compared orteronel 400 mg twice daily (BID) plus prednisone 5 mg BID to placebo plus prednisone in 1,560 men with progressive chemotherapy-naïve mCRPC (rising PSA and/or radiographic evidence of metastases) and serum testosterone < 50 ng/dL post orchiectomy or with maintained GnRH suppression. In the study, men with progressive mCRPC were randomized 1:1 to either treatment or control groups. The final analysis for rPFS was conducted at an interim analysis for OS, and the final analysis for OS was conducted at 600 deaths. The results will be presented by Ronald DeWit, MD, PhD, Erasmus MC Cancer Institute. Key secondary endpoints showed more patients experienced at least a 50 percent decrease in prostate-specific antigen and favorable circulating tumor cell (CTC) counts at 12 weeks in the treatment arm compared to the control. Common all-grade adverse events with orteronel and prednisone compared to control included nausea (36% vs. 15%), fatigue (34% vs. 20%), constipation (33% vs. 15%) and diarrhea (28% vs. 14%); 30 percent vs. 18 percent of patients in the orteronel arm and control arm, respectively, discontinued due to adverse events. No new safety signals attributed to orteronel were identified in this study.

About orteronel
Orteronel, discovered by Takeda, is an investigational oral, non-steroidal, selective inhibitor of 17,20-lyase, a key enzyme in the production of steroidal hormones including androgens. Synthesis of androgens outside the testes contributes to disease progression in castration-resistant prostate cancer (CRPC).

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