Takeda decided to terminate the development orteronel for cancer of the prostate -
Takeda Pharmaceutical Company Limited (TSE: 4502) announced today that it has voluntarily decided to terminate the development program for orteronel (TAK-700) for prostate cancer.
The decision follows the results of two clinical phase 3 trials in metastatic castration-resistant cancer of the prostate (RCMPA). Studies have found any more orteronel prednisone could prolong the time patients lived before their cancer has progressed, it has not prolong overall survival in these patients. After carefully considering the data from these trials, the Company determined that the drug has not shown sufficient clinical profile to move forward in RCMPA, given the availability of alternative therapies.
On 14 May 2014, Takeda announced results of ELM-CP4, a pivotal, international, double-blind, randomized Phase 3 in men with mCRPC who have not received chemotherapy, which showed that orteronel plus prednisone improved survival without radiographic progression (SSPR) versus prednisone alone, one of the two primary endpoints of the study, but did not show a statistically significant improvement in the second criterion the main study end in overall survival (OS). A previous Phase 3 trial, ELM-FP5, in men with mCRPC who had progressed during or after chemotherapy was lifted in 2013 after a pre-specified interim analysis indicated that orteronel plus prednisone would probably not meet the criterion main assessment of improvement in overall survival compared to the control group. The interim analysis showed a benefit for orteronel plus prednisone as a secondary endpoint, radiographic progression-free survival in the control arm. There were no major security problems in both studies.
Takeda is communicating with trial investigators and regulatory authorities, provide them with updated information and updated in accordance with local regulations. Takeda is working with the trial investigators and local regulatory authorities to ensure that patients who participated in the orteronel (TAK-700) Testing is the transition to appropriate therapies so that trial participants receive care appropriate. Patients enrolled in the orteronel (TAK-700) clinical trials should consult their study investigators to answer questions, and before changing their medication.
The decision follows the results of two clinical phase 3 trials in metastatic castration-resistant cancer of the prostate (RCMPA). Studies have found any more orteronel prednisone could prolong the time patients lived before their cancer has progressed, it has not prolong overall survival in these patients. After carefully considering the data from these trials, the Company determined that the drug has not shown sufficient clinical profile to move forward in RCMPA, given the availability of alternative therapies.
On 14 May 2014, Takeda announced results of ELM-CP4, a pivotal, international, double-blind, randomized Phase 3 in men with mCRPC who have not received chemotherapy, which showed that orteronel plus prednisone improved survival without radiographic progression (SSPR) versus prednisone alone, one of the two primary endpoints of the study, but did not show a statistically significant improvement in the second criterion the main study end in overall survival (OS). A previous Phase 3 trial, ELM-FP5, in men with mCRPC who had progressed during or after chemotherapy was lifted in 2013 after a pre-specified interim analysis indicated that orteronel plus prednisone would probably not meet the criterion main assessment of improvement in overall survival compared to the control group. The interim analysis showed a benefit for orteronel plus prednisone as a secondary endpoint, radiographic progression-free survival in the control arm. There were no major security problems in both studies.
Takeda is communicating with trial investigators and regulatory authorities, provide them with updated information and updated in accordance with local regulations. Takeda is working with the trial investigators and local regulatory authorities to ensure that patients who participated in the orteronel (TAK-700) Testing is the transition to appropriate therapies so that trial participants receive care appropriate. Patients enrolled in the orteronel (TAK-700) clinical trials should consult their study investigators to answer questions, and before changing their medication.
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