Pfizer: XTANDI Plus Leuprolide Cuts Death Risk 40% In High-Risk NmHSPC Phase 3 Study

Astellas Pharma

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(RTTNews) - Pfizer Inc. (PFE) and Astellas Pharma U.S. Inc. announced final overall survival results from the Phase 3 EMBARK study evaluating XTANDI (enzalutamide), in combination with leuprolide and as monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with biochemical recurrence (BCR) at high risk for metastasis.

XTANDI plus leuprolide reduced the risk of death by 40.3% compared to leuprolide alone, making it the first and only androgen receptor inhibitor-based regimen to show an overall survival benefit in this patient population.

The 8-year overall survival rate was 78.9% for patients receiving XTANDI plus leuprolide, versus 69.5% for those on leuprolide alone. XTANDI monotherapy showed a numerical improvement in overall survival compared to leuprolide alone, but this did not reach statistical significance.

The median follow up time was 94.2 months for XTANDI in combination with leuprolide, 94 months for leuprolide only, and 93.8 months in the monotherapy XTANDI group.

The safety profile of XTANDI was consistent with that observed at the primary EMBARK analysis, and no new safety signals were identified. The most common adverse events in the XTANDI combination group were hot flashes and fatigue. The most common adverse events in the XTANDI monotherapy group were gynecomastia, hot flashes, and fatigue.

XTANDI is approved for one or more indications in more than 80 countries, including the United States, European Union, and Japan. Earlier approvals were for castration-resistant prostate cancer and metastatic castration-sensitive (hormone-sensitive) prostate cancer. It was then approved for patients with nmCSPC with BCR at high risk for metastasis in 2023 based on improved metastasis-free survival comparing the combination of enzalutamide with leuprolide vs leuprolide alone, as well as enzalutamide monotherapy vs leuprolide alone.

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