GTx says enobosarm meets primary efficacy endpoint in ongoing phase 2 trial
GTx announced that enobosarm achieved the pre-specified primary efficacy endpoint in the 9 mg dose cohort from patients in both stage 1 and the ongoing stage 2 of its Phase 2 clinical trial in women with advanced, estrogen receptor positive, androgen receptor positive breast cancer. The primary efficacy endpoint requires at least nine patients, out of a total of 44 evaluable patients, to achieve clinical benefit, defined as either a complete response, partial response or stable disease, as measured by Response Evaluation Criteria in Solid Tumors at 24 weeks of treatment. In this ongoing trial, the efficacy endpoint was achieved in the first 22 confirmed evaluable patients, and the trial will continue enrolling and treating eligible patients with enobosarm until 44 evaluable patients have completed the trial. Enobosarm has been well tolerated among patients treated to date in the 9 mg dose cohort with the majority of adverse events being either grade 1 or 2. The company plans to report top-line clinical results from these 22 evaluable patients from the 9 mg dose cohort in December, and expects to report top-line clinical results from the full study by the middle of 2017, following completion of the clinical trial.