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DewDiligence

04/29/23 2:57 PM

#5500 RE: DewDiligence #5462

PFE/Astellas—Xtandi full_dataset_from_phase-3 EMBARK trial_presented_at_AUA:

https://www.pfizer.com/news/press-release/press-release-detail/xtandir-enzalutamide-plus-leuprolide-reduced-risk

Astellas Pharma…and Pfizer…announced today that XTANDI (enzalutamide) plus leuprolide significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI], 0.30–0.61; P<0.0001), as assessed by the primary endpoint of metastasis-free survival (MFS), in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR).

These data from the Phase 3 EMBARK trial, which evaluated patients across three study arms (XTANDI plus leuprolide [n=355], placebo plus leuprolide [n=358], or XTANDI monotherapy [n=355]), were presented as a plenary session during the 2023 American Urological Association Annual Meeting…

Please see #msg-171466844 for related info.