Erleada oral presentations at AUA meeting demonstrate importance of prostate specific antigen (PSA) .

The post-hoc analysis also supports the use of PSA as a predictive biomarker in the treatment of patients with advanced prostate cancer. These findings were presented during two podium sessions at the virtual American Urological Association Annual Meeting (AUA 2021), September 10-13.

The post-hoc analysis (Abstract #PD34-11) of the Phase III TITAN and SPARTAN studies examined PSA kinetics in 2,259 patients with either mCSPC (TITAN) or nmCRPC (SPARTAN). Results showed that patients with advanced prostate cancer, whether mCSPC or nmCRPC, treated with Erleada plus androgen deprivation therapy (ADT) had rapid, deep and durable PSA declines as early as three months and continuing beyond a year after initiating Erleada therapy. In mCSPC (TITAN), the percentage of patients with a PSA decline of greater than 50 percent or greater than 90 percent or with an undetectable PSA (<0.2ng ml) was approximately three times higher for patients treated with erleada plus adt, compared to patients treated with adt alone. in nmcrpc (spartan), no psa decline was observed in patients treated with adt alone, as may be expected, but the addition of erleada showed robust psa decline, including undetectable levels in a significant proportion of patients, similar to titan.></0.2ng>

In both studies, those patients who achieved a deeper PSA decline (defined as greater than 90 percent from baseline and/or a PSA nadir of less than 0.2 ng/mL) also showed a rapid PSA decline ( less than 3 months across both studies); a faster and deeper PSA decline was correlated with longer overall survival. Further, median time to deep PSA decline appeared to be more rapid for Erleada plus ADT (1.9 months for TITAN, 2.8 months for SPARTAN) than has been previously reported for other therapies.

In a separate presentation (Abstract #PD05-08), a U.S. real-world study of 193 patients with nmCRPC treated with Erleada plus ADT for an average of approximately one year found that the majority of patients demonstrated high treatment adherence, with greater than 90 percent of patients adhering to therapy in both Black and non-Black subgroups (90.1 percent and 94.5 percent, respectively). Moreover, the majority (83.5 percent) of the overall population – regardless of race – achieved a 50 percent reduction in PSA (PSA50 response) in the first six months and 86 percent reduction at 12 months after initiating Erleada. These results were consistent with PSA responses reported from the Phase III results of the SPARTAN trial, which showed that 90 percent of patients achieved greater than 50 percent reduction in PSA by three months, and maintained that response 12 months after initiating Erleada.