Novel Blood Test May Identify New Biomarker in Prostate Cancer

Excerpt:

“By assessing plasma androgen receptor (AR) gene status assessment with multiplex droplet digital PCR (ddPCR), European researchers could predict which patients with castration-resistant prostate cancer (CRPC) were most likely to have poorer outcomes while undergoing targeted therapy, according to results from the PREMIER trial published in the Annals of Oncology.

“Researchers said there was a ‘significant association’ for AR gain and poorer overall survival (OS) for both chemotherapy-naïve patients (HR, 3.98; 95% CI, 1.75-9.10; P <.001) and patients previously treated with docetaxel (HR, 3.81; 95% CI, 2.28-6.37; P <.001). AR gain was also associated with poorer OS for chemotherapy-naïve patients treated with enzalutamide (Xtandi) or abiraterone acetate (Zytiga; HR, 2.18; 95% CI, 1.08-4.39; P = .03) and for patients previously treated with docetaxel (HR, 1.95; 95% CI, 1.23-3.11; P = .01).”

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GTx Reports Results from Ongoing Enobosarm Phase 2 Clinical Trial in ER+/AR+ Breast Cancer

Excerpt:

“GTx, Inc. (GTXI) announced today positive initial data from its ongoing open-label enobosarm Phase 2 clinical trial in women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer. The pre-specified threshold for success of the trial was met early in the 9 mg cohort with 9 patients achieving a clinical benefit response at 24 weeks among the first 22 evaluable patients in that cohort, as reported by the Company on November 28, 2016. Clinical Benefit Response (CBR) is defined as a complete response (CR), partial response (PR) or stable disease (SD), as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks of treatment.”

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Enobosarm Meets Pre-Specified Primary Efficacy Endpoint in Ongoing Phase 2 Clinical Trial in ER+/AR+ Breast Cancer

Excerpt:

“GTx, Inc. (Nasdaq: GTXI) today 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 (ER+), androgen receptor positive (AR+) 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 (RECIST) 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.”

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