ASCO 2021: ADT Plus Novel Targeted Therapy in Metastatic Prostate Cancer
Posted: Monday, June 14, 2021
According to the results of a phase III trial, androgen-deprivation therapy (ADT) plus TAK-700 (also known as orteronel), an oral selective nonsteroidal 17,20-lyase inhibitor, may offer some clinical benefit compared with ADT plus bicalutamide among patients with metastatic hormone-sensitive prostate cancer. Despite improvements in progression-free survival and prostate-specific antigen (PSA) responses, however, the improvement in overall survival did not meet the prespecified criteria for statistical significance. The results were presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 5001).
“This trial sets a new landmark for survival estimates when patients with metastatic hormone-sensitive prostate cancer have access to multiple approved subsequent life-prolonging therapies,” Neeraj Agarwal, MD, of the University of Utah, Salt Lake City, and colleagues concluded.
The researchers randomly assigned 1,279 patients with newly diagnosed metastatic hormone-sensitive prostate cancer to receive ADT plus TAK-700 (n = 638) or ADT plus bicalutamide (n = 641). The median follow-up was 4.9 years.
The median PSA levels were 30 ng/mL. Nearly half of the patient population had extensive disease. No significant difference in overall survival was observed between patients treated with TAK-700 versus bicalutamide (81.1 months vs. 70.2 months, respectively; P = .04). However, the median progression-free survival was significantly longer for patients who received TAK-700 than bicalutamide (47.6 months vs. 23.0 months; P < .0001). Patients who received TAK-700 also achieved significantly improved PSA responses compared with bicalutamide.
Overall, 43% of patients treated with TAK-700 experienced severe adverse events versus 14% of patients treated with bicalutamide. Adverse events included hypertension and fatigue. Grade 5 adverse events were reported in five patients who received TAK-700 and a single patient treated with bicalutamide.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
