Positive data reported from the Phase 3 EMBARK study evaluating Xtandi plus Leuprolide combination in comparison to Placebo

This combination significantly reduced the risk of metastasis or death by 58% versus placebo as assessed by the primary endpoint of metastasis-free survival (MFS)

• The most common adverse events for combination therapy: fatigue, hot flush, and arthralgia
• The most common adverse events for monotherapy: fatigue, gynecomastia, and arthralgia

Positive trend in the key secondary endpoint of overall survival (OS) was also observed in the Xtandi combination arm

Potential regulatory submission in 2023