Pfizer and Astellas’ Xtandi (enzalutamide) has improved overall survival (OS) in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC), but only as a combination therapy.
First approved in 2012, the prostate cancer therapy met the secondary endpoint of OS in the Phase III EMBARK trial (NCT02319837) when combined with leuprolide, compared to placebo plus leuprolide, in patients with nmHSPC with biochemical recurrence (BCR) and high risk for metastasis.
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Despite this, while a favourable trend was observed, there was no statistical significance between Xtandi monotherapy and placebo or leuprolide.
In the trial, patients were randomised across three arms: Xtandi plus leuprolide, placebo plus leuprolide, or Xtandi alone.
This update comes two years after the companies announced the trial met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with Xtandi plus leuprolide versus placebo plus leuprolide.
Although Pfizer and Astellas have not yet disclosed additional details about the OS data, they stated that full results will be presented at an upcoming medical meeting. They also noted that safety results were consistent with the known safety profile of Xtandi.
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By GlobalDataCarolina Urologic Research Center’s medical director Dr Neal Shore said: “These data demonstrate that treatment with Xtandi can extend life for men with nmHSPC and high-risk BCR who have relapsed after initial curative-intent therapy with prostatectomy, radiation therapy or both, further validating EMBARK’s metastasis-free survival (MFS) data.
“While men with nmHSPC with high-risk BCR now have expanded treatment choices, these results demonstrate a clear clinical benefit, including both MFS and OS, supporting the clinical practice of initiating Xtandi for these patients.”
Xtandi is currently approved in more than 80 countries, including the US, Europe and Japan. The US Food and Drug Administration (FDA) approved Xtandi for use in nmHSPC with high-risk BCR in November 2023, based on the EMBARK trial meeting its primary endpoint. The European Commission (EC) granted a label expansion for its use in the same patient population in April 2024.
GlobalData predicts the prostate cancer market will be worth $22.62bn in 2030. Xtandi sales are set to start dropping due to the drug’s patent expiring in 2026 in Europe and 2027 in the US. As a result, GlobalData predicts that sales of Xtandi will reach $5.59bn in 2025 and will drop to $2.24bn in 2030.
The pharmaceutical industry is facing one of the most significant patent cliffs of the decade, with major companies preparing for substantial revenue losses, according to market analysts.
A recent GlobalData report projects a sharp decline in the proportion of global drug sales protected by patents, with the figure expected to drop to just 4% by 2030. This compares to 12% in 2022 and 6% in 2024.
GlobalData is the parent company of Clinical Trials Arena.
