ERLEADA® (apalutamide) Oral Presentations Demonstrate Importance of Prostate Specific Antigen (PSA) as Key Efficacy Indicator and Show Strong Patient Adherence Rates

Post-hoc analysis shows that ERLEADA® provides rapid, deep, and durable PSA declines in advanced prostate cancer, with depth and speed of response correlating to improved  overall survival

Real-world data demonstrate that, across racial groups, patients prescribed ERLEADA® for non-metastatic castration-resistant prostate cancer stay on therapy

San Francisco, CA ( -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced new data demonstrating robust prostate-specific antigen (PSA) response and strong adherence rates in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with ERLEADA® (apalutamide) in the real-world clinical setting. The strong PSA response was also seen in a separate post-hoc analysis that showed a correlation between rapid and deep PSA response and prolonged survival in both metastatic castration-sensitive prostate cancer (mCSPC) and nmCRPC. 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 3 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.1 In mCSPC (TITAN), the percentage of patients with a PSA decline of ≥50 percent or ≥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.1 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.1

In both studies, those patients who achieved a deeper PSA decline (defined as ≥90 percent from baseline and/or a PSA nadir of ≤0.2 ng/mL) also showed a rapid PSA decline (<3 months across both studies); a faster and deeper PSA decline was correlated with longer overall survival.1 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.2

“The sooner that urologists and oncologists have an indicator that a patient is benefitting from a therapy, the better able they are to provide the best care,” said Tracy McGowan, M.D., Therapeutic Head, Prostate Cancer, U.S. Medical Affairs, Janssen Biotech, Inc. “As reported in this post-hoc analysis, PSA is an important early predictive indicator in patients with either mCSPC or nmCRPC, and depth and speed of PSA decline were significantly improved with apalutamide treatment.”
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 >90 percent of patients adhering to therapy in both Black and non-Black subgroups (90.1 percent and 94.5 percent, respectively).3

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®.3 These results were consistent with PSA responses reported from the Phase 3 results of the SPARTAN trial, which showed that 90 percent of patients achieved >50 percent reduction in PSA by three months, and maintained that response 12 months after initiating ERLEADA.4

“Outside of a clinical trial setting, healthcare professionals are focused on ensuring a therapy can benefit patients treated in the real world. To have both high adherence rates and robust PSA reductions is very encouraging,” said Benjamin Lowentritt, M.D., Director Prostate Cancer Care Program, Chesapeake Urology, and Immediate Past President, AUA, Mid-Atlantic Region and lead study investigator.* “These findings support the use of apalutamide in delaying disease progression and metastasis in patients with nmCRPC across various demographics.”

To date, published results on ERLEADA® include data from more than 2,000 patients across three Phase 3 clinical studies. ERLEADA® has shown a statistically significant improvement in overall survival with a consistent safety profile while maintaining health-related quality of life in both approved indications of mCSPC and nmCRPC.4 ERLEADA® is currently approved in more than 74 countries.

Source: "ERLEADA® (Apalutamide) Oral Presentations Demonstrate Importance Of Prostate Specific Antigen (PSA) As Key Efficacy Indicator And Show Strong Patient Adherence Rates". 2021. Janssen. 
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