Johnson & Johnson has released results from a Phase II clinical trial evaluating ERLEADA (apalutamide) as an adjuvant therapy with androgen deprivation therapy (ADT) in high-risk localised prostate cancer (HRLPC) patients post-radical prostatectomy (RP).
The single-arm, open-label, multicentre study involved 108 subjects enrolled across 32 US community urologic practices.
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The participants were treatment-naïve individuals with HRLPC who had undergone RP. They received a daily dose of 240mg ERLEADA for 12 cycles, alongside ADT for one year.
Assessing the biochemical recurrence (BCR)-free rate was the trial’s primary goal.
The secondary objectives of the study included assessing the testosterone recovery rate and the safety of the treatment regimen.
The findings indicated that the patients who underwent the treatment regimen exhibited a 100% BCR-free rate at the 24-month mark, meeting the primary endpoint.
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By GlobalDataThis outcome suggests that the therapy effectively prevents the recurrence of cancer as measured by PSA levels after an additional year of follow-up post-treatment.
The study also reported a serum testosterone recovery rate of 76.4% after 12 months.
The safety profile of ERLEADA in combination with ADT was in line with prior studies.
Treatment-emergent adverse events (TEAEs) were experienced by 99.1% of the patients, with 22.2% of these events being grade 3 or 4 in severity.
An androgen receptor inhibitor, ERLEADA is currently approved for treating patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC).
Johnson & Johnson Innovative Medicine Solid Tumor Medical Affairs vice-president Luca Dezzani said: “Despite treatment advancements over the last decade, half of patients with high-risk localised prostate cancer experience disease recurrence less than two years after radical prostatectomy, highlighting a need for treatment options that reduce longer-term risks.
“Studies like Apa-RP coupled with the continued evaluation of ERLEADAin ongoing Phase III studies are critical steps in understanding the full potential of earlier treatment intervention, with the ultimate goal of improving patient outcomes.”
