Bayer reports that its Phase III trial of darolutamide in combination with androgen deprivation therapy (ADT) showed that this treatment significantly improved radiological progression-free survival (rPFS) compared with placebo + ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Safety analyses indicate that darolutamide + ADT is comparable to placebo + ADT, confirming its well-established tolerability profile observed in previous trials.

Bayer plans to present the detailed results at a forthcoming scientific conference, and to seek global regulatory approval to extend darolutamide's indication.


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