Site Editor
Sandy Srinivas, MD
Sandy Srinivas, MD
Posted: Friday, September 23, 2022
A first-in-class nonsteroidal agent, ODM-208, appears to be effective in blocking the production of steroid hormones in patients with heavily pretreated metastatic castration-resistant prostate cancer with androgen receptor ligand–binding domain mutations. ODM-208 also yielded antitumor activity, according to Karim Fizazi, MD, PhD, of Institut Gustave Roussy, Villejuif, France, and colleagues. The preliminary results of the phase II expansion of the CYPIDES trial were presented at the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract 1364MO).
ODM-208—a selective inhibitor of CYP11A, the rate-limiting enzyme of steroid biosynthesis—was given orally at a dose of 5 mg twice daily to 45 patients with progressing metastatic castration-resistant prostate cancer who had previously received at least one line of a second-generation androgen receptor pathway inhibitor and at least one line of taxane-based chemotherapy. All patients had a documented activating androgen receptor ligand–binding domain mutation.
Of the enrolled patients, 51% had previously received both abiraterone and enzalutamide, and 65% had received both docetaxel and cabazitaxel. Based on emerging data, ODM-028 “profoundly suppressed” androgen synthesis, the investigators reported, reducing prostate-specific antigen levels by more than 50% in more than half of study patients. Additionally, the authors employed Response Evaluation Criteria in Solid Tumors to document at least four partial responses in 17 evaluable patients. As for safety, ODM-208 appears to be well tolerated; the dose given in phase II was lower than the doses in phase I, which corresponded with a much lower rate of hospitalization for adrenal insufficiency in phase II (2.3 vs. 33% to date).
Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.
JNCCN Spotlights
