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Genentech's Phase III Study Meets Co-primary Endpoint Of RPFS In Patients With MCRPC

Genentech, a member of the Roche Group (RHHBY), said that the Phase III IPATential150 study met its co-primary endpoint of radiographic progression-free survival or rPFS in patients with metastatic castration-resistant prostate cancer or mCRPC and whose tumors had PTEN loss.

In the patient group, ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, compared to current standard of care plus placebo. The other co-primary endpoint of rPFS in the overall study population (intention-to-treat) was not met.

The safety profile for the combination of ipatasertib and abiraterone was consistent with previous analyses and known risks.

The company noted that initial data are encouraging, but overall survival benefit and additional secondary endpoints are not yet mature. The trial will continue until the next planned analysis and data will be shared with health authorities.

"Prostate cancer remains a leading cause of death in men worldwide and patients with metastatic castration-resistant prostate cancer can be difficult to treat," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development.

Genentech said its clinical development program for ipatasertib focuses on tumors that are frequently found to have activation of the PI3K/AKT pathway. In addition to prostate cancer, ipatasertib is being studied in certain types of breast cancer including triple-negative breast cancer and hormone-receptor positive (HR+), HER2- negative breast cancer. Results are anticipated later in 2020.

Ipatasertib is an oral, highly specific, investigational medicine designed to target and bind to all three isoforms of AKT, which blocks the PI3K/AKT signaling pathway and may prevent cancer cell growth and survival.

Ipatasertib is being studied in tumors that are frequently found to have activation of the PI3K/AKT pathway, including breast and prostate cancers. Clinical studies are ongoing to evaluate the efficacy and safety of ipatasertib and the opportunity it may provide to address significant unmet needs for patients with these diseases.

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