Pfizer pushes a non-metastatic prostate survival edge
In hormone-sensitive prostate cancer Astellas and Pfizer’s Xtandi has the non-metastatic niche to itself, and it looked to have cemented its lead on Thursday with a positive topline overall survival result in the Embark trial. However, it wasn’t all rosy: only an Xtandi/leuprolide combo showed a statistically significant OS benefit over leuprolide alone, while Xtandi monotherapy fell short. Pfizer claimed a favourable trend with monotherapy; detailed data, expected at a future medical meeting, will show how close it came. A question is how this mixed result might affect Xtandi’s use in the non-metastatic setting. The drug gained full US approval here in 2023, based on metastasis-free survival in Embark, with success for both Xtandi monotherapy and the leuprolide combo. As for the competition, no other androgen receptor antagonists are FDA approved for non-metastatic HSPC, although Bayer’s Nubeqa and Johnson & Johnson’s Erleada are in phase 3. Even so, results aren’t expected for another couple of years at best, so Xtandi has a bit more time to make the most of its niche.
Cross-trial comparison in non-metastatic hormone-sensitive prostate cancer (HSPC)
| Project | Company | Status | Note |
|---|---|---|---|
| Xtandi | Pfizer | FDA approved Nov 2023 based on metastasis-free survival in Embark (HR 0.42 for Xtandi + leuprolide & 0.63 for Xtandi monotx, vs leuprolide) | Ph3 Embark OS results toplined Jul 2025: met statistical significance with Xtandi + leuprolide, but not Xtandi monotx |
| Nubeqa | Bayer/ Orion | FDA approved in metastatic, but not non-metastatic HSPC | Ph3 Arastep in non-metastatic; Nubeqa + LHRH agonist/antagonist, vs LHRH agonist/antagonist; completes Jul 2027 |
| Erleada | J&J | FDA approved in metastatic, but not non-metastatic HSPC | Ph3 Primordium in non-metastatic; Erleada + LHRH agonist + radiotherapy, vs LHRH agonist + radiotherapy; primary completion Aug 2029 |
| Zytiga | J&J | FDA approved in metastatic, but not non-metastatic HSPC | No non-metastatic ph3s |
Note: LHRH=luteinising hormone-releasing hormone, includes leuprolide. Source: OncologyPipeline.
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