Enzalutamide (enzalutamide) current clinical trial status and applicable populations

Enzalutamide is an oral nonsteroidal androgen receptor inhibitor widely used to treat prostate cancer. It inhibits the growth of tumor cells by blocking the binding of androgens to their receptors. In recent years, clinical trials of enzalutamide in China have been steadily advancing, covering multiple prostate cancer stages, including castration-resistant (CRPC), castration-sensitive (CSPC), as well as metastatic and non-metastatic populations.

In July 2024, the National Food and Drug Administration (NMPA) officially approved enzalutamide for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), which is its third approved indication in China. Enzalutamide has previously been approved for the treatment of non-metastatic CRPC and metastatic CRPC, marking the continued expansion of its therapeutic spectrum. The expansion of the applicable population will also benefit more prostate cancer patients.

The latest ChinaARCHESClinicalIII trial (NCT04076059) data show that enzalutamide combined with androgen deprivation therapy ( ADT) significantly prolonged progression-free survival (rPFS) and castration resistance time, and reduced the risk of PSA progression by approximately 87%. These results verify the superiority of enzalutamide in the mHSPC stage, and also lay a solid foundation for its widespread clinical application.

At present, enzalutamide is increasingly used clinically in China and is suitable for people with prostate cancer in various stages. Its efficacy has been confirmed in multiple high-quality clinical studies and is especially suitable for advanced patients who have not yet received chemotherapy. In the future, with the accumulation of more local clinical data, enzalutamide is expected to be included in more treatment guidelines, providing strong support for the standardized treatment of prostate cancer.

Reference materials:https://www.drugs.com/