The Janssen Pharmaceutical Companies of Johnson & Johnson has reported new data that showed strong prostate-specific antigen (PSA) response and adherence rates in non-metastatic castration-resistant prostate cancer (nmCRPC) patients treated with Erleada (apalutamide) in the real-world clinical setting.
An oral androgen receptor inhibitor, Erleada is intended to treat nmCRPC patients and metastatic castration-sensitive prostate cancer (mCSPC) patients.
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By GlobalDataIn another post-hoc analysis, Erleada demonstrated to offer a robust PSA response, indicating an association between quick and deep PSA response and continued survival in mCSPC as well as nmCRPC.
The post-hoc analysis of the Phase III TITAN and SPARTAN clinical trials analysed PSA kinetics in 2,259 subjects with either mCSPC or nmCRPC.
Results showed that advanced prostate cancer patients treated with Erleada plus androgen deprivation therapy (ADT) had quick, profound and long-lasting PSA reductions as early as three months.
Furthermore, such responses lasted over a year after commencing the treatment.
In the TITAN trial involving mCSPC patients, the percentage of subjects with a PSA decline of ≥50% or ≥90% or with an undetectable PSA was nearly three times greater for those receiving Erleada plus ADT versus those on ADT alone.
No PSA reductions were observed in nmCRPC subjects treated with ADT alone in the SPARTAN trial while adding Erleada demonstrated a strong reduction in PSA.
In a substantial number of subjects, undetectable levels of PSA were reported, which is in line with the TITAN trial.
In addition, the median time to deep PSA decline was observed to be quicker for Erleada plus ADT in both the trials than reported earlier for other treatments.
Median time to deep PSA decline was 1.9 months and 2.8 months for TITAN and SPARTAN trials, respectively.
The post-hoc analysis data backs the usage of PSA as a predictive biomarker for treating advanced prostate cancer patients, the company noted.
Janssen Biotech US Medical Affairs Prostate Cancer therapeutic head Tracy McGowan said: “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.
“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 US real-world study involving 193 nmCRPC patients receiving Erleada plus ADT for an average of nearly one year, the majority of them showed greater treatment adherence, with more than 90% of patients adhering to the treatment in Black as well as non-Black subgroups.
Furthermore, 83.5% of the overall population attained a 50% PSA decline in the initial six months and an 86% decline at one year on starting Erleada therapy.
Last month, Janssen reported that its Rybrevant (amivantamab-vmjw) demonstrated anti-tumour activity in non-small cell lung cancer patients with mesenchymal-epithelial transition exon 14 skipping mutations in a Phase I CHRYSALIS clinical trial.
