Pre-specified interim analysis indicated study would likely not meet the primary endpoint of improved overall survival
OSAKA, Japan I July 26, 2013 and CAMBRIDGE, MA, USA I July 25, 2013 I Takeda Pharmaceutical Company Limited (“Takeda”) announced today that it has unblinded the ELM-PC 5 Phase 3 study (C21005) of orteronel plus prednisone compared to placebo plus prednisone in patients with metastatic, castration- resistant prostate cancer (mCRPC) that had progressed during or following chemotherapy based on the recommendation of the Independent Data Monitoring Committee (IDMC). The pre-specified interim analysis indicated that orteronel plus prednisone would likely not meet the primary endpoint of improved overall survival (OS) when compared to the control arm (HR 0.894, p=0.226). The interim analysis did show an advantage for orteronel plus prednisone for the secondary endpoint, radiographic progression-free survival (rPFS) over the control arm (HR 0.755, p=0.00029). In addition, there were no safety concerns.
Takeda intends to allow all patients participating in the ELM-PC 5 study who were randomized to orteronel to continue on therapy following consultation with their physicians and study investigators. The appropriate health authorities and clinical study investigators are being notified that the ELM-PC 5 study has been unblinded.
The decision to unblind the ELM-PC 5 study is not expected to impact other ongoing company-sponsored clinical trials with orteronel, including the ELM-PC 4 pivotal Phase 3 study (C21004) comparing orteronel plus prednisone to placebo plus prednisone in patients with chemotherapy-naive mCRPC.
“While we are disappointed that the ELM-PC 5 study did not meet the primary endpoint of improved overall survival, we remain committed to developing new therapies for patients with prostate cancer,” stated Michael Vasconcelles, M.D., Global Head of the Takeda Oncology Therapeutic Area Unit. “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. Takeda remains dedicated to developing innovative treatment options for patients with cancer.”
Safety and efficacy findings from the trial will be presented when fully available and analyzed.
Orteronel is an investigational oral, non-steroidal, selective inhibitor of 17,20-lyase, a key enzyme in the production of steroidal hormones.
SOURCE: Takeda Pharmaceutical
Post Views: 167
Pre-specified interim analysis indicated study would likely not meet the primary endpoint of improved overall survival
OSAKA, Japan I July 26, 2013 and CAMBRIDGE, MA, USA I July 25, 2013 I Takeda Pharmaceutical Company Limited (“Takeda”) announced today that it has unblinded the ELM-PC 5 Phase 3 study (C21005) of orteronel plus prednisone compared to placebo plus prednisone in patients with metastatic, castration- resistant prostate cancer (mCRPC) that had progressed during or following chemotherapy based on the recommendation of the Independent Data Monitoring Committee (IDMC). The pre-specified interim analysis indicated that orteronel plus prednisone would likely not meet the primary endpoint of improved overall survival (OS) when compared to the control arm (HR 0.894, p=0.226). The interim analysis did show an advantage for orteronel plus prednisone for the secondary endpoint, radiographic progression-free survival (rPFS) over the control arm (HR 0.755, p=0.00029). In addition, there were no safety concerns.
Takeda intends to allow all patients participating in the ELM-PC 5 study who were randomized to orteronel to continue on therapy following consultation with their physicians and study investigators. The appropriate health authorities and clinical study investigators are being notified that the ELM-PC 5 study has been unblinded.
The decision to unblind the ELM-PC 5 study is not expected to impact other ongoing company-sponsored clinical trials with orteronel, including the ELM-PC 4 pivotal Phase 3 study (C21004) comparing orteronel plus prednisone to placebo plus prednisone in patients with chemotherapy-naive mCRPC.
“While we are disappointed that the ELM-PC 5 study did not meet the primary endpoint of improved overall survival, we remain committed to developing new therapies for patients with prostate cancer,” stated Michael Vasconcelles, M.D., Global Head of the Takeda Oncology Therapeutic Area Unit. “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. Takeda remains dedicated to developing innovative treatment options for patients with cancer.”
Safety and efficacy findings from the trial will be presented when fully available and analyzed.
Orteronel is an investigational oral, non-steroidal, selective inhibitor of 17,20-lyase, a key enzyme in the production of steroidal hormones.
SOURCE: Takeda Pharmaceutical
Post Views: 167
