Phase II Apa-RP Study of Erleada Shows Promise in Treatment of Patients with High-Risk Localized Prostate Cancer Who Have Undergone Previous Radical Prostatectomy

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Johnson & Johnson (J&J) announced promising results from the Phase II Apa-RP study, which measured the effectiveness of Erleada (apalutamide) in combination with androgen deprivation therapy (ADT) in patients with high-risk localized prostate cancer who had undergone radical prostatectomy (RP). According to the company, findings included a 100% biochemical recurrence-free rate at 24 months, which translated to no patients showing signs of returning cancer. Additionally, the treatment showed promising testosterone recovery rates and a safety profile consistent with previous studies.

The treatment achieved the trial’s primary endpoint by displaying that after 12 months of treatment with Erleada plus ADT adjuvant to RP, no patients experienced biochemical recurrence after another one-year follow up.¹

“Findings from the Apa-RP study support the benefit of treatment intensification with apalutamide and androgen deprivation therapy following radical prostatectomy for patients who are at high risk for BCR and thus progression to metastatic prostate cancer,” said Neal Shore, MD, FACS, steering committee chair, chief medical officer, surgical oncology and urology, Genesis Care, in a press release. “Results from this study encourage additional research for high-risk localized prostate cancer and highlight the promise of bringing treatment into earlier stages of disease following radical prostatectomy.”

In 2022, Erleada also displayed significant rates of rapid and deep prostate-specific antigen (PSA) response among patients with metastatic castration-sensitive prostate cancer (mCSPC) through real-world evidence data. This data included 186 patients treated with Erleada and another 165 treated with enzalutamide from 69 community urology practices in the United States. After six months, approximately 69% of patients treated with Erleada demonstrated a PSA90 response and an estimated 55% of those treated with enzalutamide experienced the same.²

“Deep PSA response is an important early prognostic factor for achieving longer radiographic progression-free survival and overall survival in patients with metastatic castration-sensitive prostate cancer,” said lead study investigator Benjamin Lowentritt, MD, director, prostate cancer care program, Chesapeake Urology, past president, AUA, Mid-Atlantic Region, in a press release. “These real-world data are consistent with and reinforce the benefit of Erleada as reported in the clinical trial setting, providing prescribers with important insights regarding time to and durability of PSA90 responses for commonly prescribed mCSPC medications.”

According to the American Cancer Society, prostate cancer is one of the leading causes of cancer-related deaths in the United States, with only lung cancer claiming more lives. On average, one in every 44 men are expected to die as a result of prostate cancer, while approximately 3.3 million who have previously been diagnosed are still alive.³

“Despite treatment advancements over the last decade, half of patients with high-risk localized prostate cancer experience disease recurrence less than two years after radical prostatectomy, highlighting a need for treatment options that reduce longer-term risks,” said Luca Dezzani, MD, VP, medical affairs, solid tumor, J&J innovative medicine, in the press release. “Studies like Apa-RP coupled with the continued evaluation of Erleada in ongoing Phase 3 studies are critical steps in understanding the full potential of earlier treatment intervention, with the ultimate goal of improving patient outcomes.”

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. Johnson & Johnson. May 3, 2024. Accessed May 6, 2024. https://www.jnj.com/media-center/press-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-surgery

2. New ERLEADA® (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC). Johnson & Johnson. February 14, 2022. Accessed May 6, 2024. https://www.jnj.com/media-center/press-releases/new-erleada-apalutamide-analysis-demonstrates-rapid-deep-prostate-specific-antigen-psa-response-in-patients-with-metastatic-castration-sensitive-prostate-cancer-mcspc

3. Key Statistics for Prostate Cancer. American Cancer Society. Accessed May 6, 2024. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html#:~:text=About%201%20in%2044%20men,point%20are%20still%20alive%20today.