100% of Patients Remain Recurrence-Free at Two Years in Johnson & Johnson's Phase 2 Trial of Erleada-Based Regimen for High-Risk Localized Prostate Cancer

May 06, 2024 07:31 CST Updated 07:31

Johnson & Johnson

Medical Device R&D and Manufacturer

▎WuXiEdited by Kant Content Team

Recently, Johnson & Johnson announced the results of the open-label, single-arm Phase 2 clinical trial Apa-RP. This study evaluated the effectiveness of using Erleada (apalutamide) and androgen deprivation therapy (ADT) as adjuvant treatments in high-risk localized prostate cancer (HRLPC) patients undergoing radical prostatectomy (RP). The study found,The biochemical recurrence (BCR) rate within 24 months after RP surgery for patients who received this treatment regimen was 0%.

Approximately 300,000 people are diagnosed with prostate cancer each year in the United States, of which up to 40% are high-risk patients. Disease recurrence remains a significant issue in prostate cancer. Up to 50% of patients may experience recurrence within ten years after surgery, posing substantial risks of disease progression and mortality.

This study achieved the primary endpoint,Patients who received 12 months of Erleada plus ADT as adjuvant therapy after RP showed no confirmed biochemical recurrence during an additional 12 months of follow-up.Moreover, the treatment regimen at 12 monthsThe recovery rate of serum testosterone (≥150 ng/dL) was 76.4% (95% CI, 65.0–84.5).The safety of Erleada in combination with ADT was consistent with previous data: 99.1% of patients reported treatment-emergent adverse events (TEAEs), with 22.2% being grade 3-4 events.

Erleada is an androgen receptor inhibitor, approved for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC).It was approved by the U.S. FDA in February 2018 for the treatment of nmCRPC and received approval in September 2019 for the treatment of mCSPC. To date, more than 200,000 patients worldwide have been treated with Erleada. Further studies are ongoing, including the phase 3 clinical trials ATLAS 15 and PROTEUS, which are evaluating Erleada for the treatment of localized high-risk or locally advanced prostate cancer.

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References:

[1] Phase 2 data for ERLEADA® (apalutamide) plus androgen deprivation therapy following radical prostatectomy in patients with high-risk localized prostate cancer show 100% biochemical free recurrence rate more than two years post-surgery. Retrieved May 3, 2024, from https://www.prnewswire.com/news-releases/phase-2-data-for-erleada-apalutamide-plus-androgen-deprivation-therapy-following-radical-prostatectomy-in-patients-with-high-risk-localized-prostate-cancer-show-100-biochemical-free-recurrence-rate-more-than-two-years-post-sur-302135663.html

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