Johnson & Johnson (J&J; NYSE: JNJ) has announced that its Phase II clinical trial for the androgen receptor inhibitor Erleada (apalutamide), in combination with androgen deprivation therapy (ADT), successfully met its primary endpoint of biochemical recurrence (BCR) in patients with high-risk localized prostate cancer (HRLPC) following radical prostatectomy (RP). The trial demonstrated a 0% BCR rate after one year of adjuvant therapy and a subsequent one-year follow-up period, an impressive outcome given the high risk of BCR and potential progression to metastasis in this patient group.
Additionally, the study reported a serum testosterone recovery rate of 76.4% at 12 months, indicating a favorable restoration of testosterone levels post-treatment. The safety profile of Erleada, as observed in this trial, was found to be in line with previous reports, further supporting its potential use in clinical settings.
As stated in the press release, Erleada is progressing to Phase III of its development, a pivotal step towards potentially expanding treatment options for patients with high-risk localized prostate cancer.- Flcube.com
