Assessing ODM-208 in Patients With mCRPC: The CYPIDES Trial

By Patrick Daly - Last Updated: September 12, 2022

In an oral presentation at the ESMO Congress 2022, the lead author of the phase 2 CYPIDES trial, Karim Fizazi, discussed preliminary findings on ODM-208—a first-in-class CYP11A1 inhibitor—in the treatment of metastatic castration-resistant prostate cancer (mCRPC).

According to Fizazi, ODM-208 demonstrated “promising antitumor activity” in heavily pretreated patients with mCRPC with androgen receptor (AR) ligand binding domain (LBD) mutations. Additionally, ODM-208 was highly effective for blocking the production of steroid hormones that may activate the AR signaling pathway.

A total of 43 patients (median years of age, 68) with a prespecified AR LBD mutation were evaluable at the March 17, 2022, data cutoff. Participants received ODM-208 5 mg twice a day alongside dexamethasone and fludrocortisone. Efficacy was evaluated according to prostate-specific antigen (PSA) measures and RECIST response criteria.

Among the cohort, 51% of patients had previously received abiraterone and enzalutamide, and 65% had received docetaxel and cabazitaxel. Based on preliminary findings, Fizazi reported that ODM-208 induced a more than 50% best reduction in PSA in over half the participants, as well as at least 4 RECIST partial responses among 17 patients with matured data.

Additionally, Fizazi noted that ODM-208 had been well-tolerated and demonstrated a much lower rate of hospitalization for adrenal insufficiency to date when compared with the phase 1 study (2.3% vs 33%, respectively).

Overall, Fizazi and colleagues supported the potential value of ODM-208 for treating patients with mCRPC who are resistant to hormone-based therapies. The study is ongoing in 18 centers across France, Finland, the UK, and the US, and more mature data will be presented.

View More Prostate Cancer Studies From the ESMO Congress 2022