Takeda Pharmaceutical Company has unblinded ELM-PC 5 Phase III study of non-steroidal, selective inhibitor of 17,20-lyase, Orteronel, in patients with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed post-chemotherapy based on interim analysis.
Pre-specified interim analysis, which was conducted by the Independent Data Monitoring Committee (IDMC), indicated that the study would not meet the primary endpoint of improved overall survival.
Designed to assess orteronel plus prednisone compared with placebo plus prednisone, the study’s interim analysis failed to show an advantage for orteronel plus prednisone for the secondary endpoint, radiographic progression-free survival (rPFS) over the control arm.
Takeda oncology therapeutic area unit global head Dr Michael Vasconcelles said the ELM-PC 5 study failed to meet the primary endpoint of improved overall survival, but the company remains committed to developing new therapies for patients with prostate cancer.
"We would like to acknowledge with gratitude the patients, their families, and the study investigators for their significant contributions to the ELM-PC 5 trial," Vasconcelles said.
All ELM-PC 5 study patients randomised to orteronel will continue on therapy following consultation with their physicians and study investigators.
The appropriate health authorities and clinical study investigators are being notified of unblinding of ELM-PC 5 Phase III study.
Ongoing, Takeda-sponsored trials with orteronel, including the ELM-PC 4 pivotal Phase III study (C21004) comparing orteronel plus prednisone to placebo plus prednisone in mCRPC patients new to chemotherapy.
Image: Micrograph showing prostatic acinar adenocarcinoma, the most common form of prostate cancer, Gleason pattern 4. H&E stain. Photo: courtesy of Nephron.