Medivation Announces Updated Enzalutamide Data In Triple-Negative Breast Cancer

(RTTNews) - Medivation Inc. (MDVN) announced updated data from a Phase 2 trial evaluating the investigational use of enzalutamide as a single agent for the treatment of advanced triple-negative breast cancer or TNBC. Results from an exploratory overall survival analysis of study data were presented during an oral plenary session at the 2015 European Cancer Congress in Vienna, Austria.

A novel gene expression profiling assay was developed using data derived from the Phase 2 trial in patients with advanced TNBC, with a goal of developing a diagnostic test that could select patients who may respond to enzalutamide treatment. Nearly half of the enrolled patients tested positive for the novel gene expression profiling assay.

An exploratory analysis of updated overall survival data demonstrated that those TNBC patients on enzalutamide whose tumors tested positive for the gene expression profile have to date experienced a 10.5-month longer median survival duration compared to those patients on enzalutamide whose tumor tested negative for the gene expression profile. The exploratory analysis demonstrated that median overall survival to date for diagnostic positive advanced TNBC patients treated with enzalutamide was 18.0 months compared with 7.5 months for diagnostic negative advanced TNBC patients treated with enzalutamide.

Medivation released its initial exploratory analysis of then current overall survival data at the 2015 American Society of Clinical Oncology Annual Meeting in June 2015. At that time, the median overall survival in patients whose TNBC was diagnostic positive was not yet reached and for those with diagnostic negative TNBC the median overall survival was 7.5 months. Medivation provided full details of the trial design in its Form 10-Q filed with the Securities and Exchange Commission on August 6, 2015.

The most common adverse events reported as related to enzalutamide treatment in the intent-to-treat population were fatigue, nausea, decreased appetite, diarrhea, and hot flush.

"The data presented today highlight the potential advantages of using a novel genomic profiling assay to identify patients who might respond to treatments," said Amy Peterson, M.D., vice president of clinical development at Medivation. "This approach could have implications for future development of targeted therapies in triple negative breast cancer."

MDVN closed the friday's regular trading session at $41.64, down 7.55%.