J&J's Erleada Improves Survival in Prostate Cancer Study

Johnson & Johnson (J&J) has revealed findings from a real-world study that compared its drug Erleada (apalutamide) with Pfizer and Astellas’ Xtandi (enzalutamide) for treating patients with metastatic castration-sensitive prostate cancer (mCSPC). This head-to-head study analyzed data from more than 3,700 patients who were administered these androgen receptor pathway inhibitors (ARPIs).

The results were significant: Erleada demonstrated a statistically meaningful overall survival benefit over a 24-month period when compared to Xtandi. Specifically, the study, presented at the European Congress of Oncology Pharmacy, indicated that patients who began treatment with Erleada had a 23% reduced risk of death at the two-year mark. Of those treated with Erleada, 87.6% were still alive at 24 months, in contrast to those who started with Xtandi.

J&J stated that these findings aligned with the outcomes of the late-stage TITAN trial. In the TITAN trial, Erleada, combined with androgen deprivation therapy (ADT), had shown a notably superior overall survival benefit compared to ADT alone, with a median follow-up of 22.7 months initially and later extending to 44 months.

In the United States, around 300,000 new prostate cancer cases are diagnosed each year. Despite advancements in treatment options, the recurrence rate of the disease remains high. Currently, Erleada is approved by the US Food and Drug Administration for treating both mCSPC and non-metastatic castration-resistant prostate cancer. On the other hand, Xtandi is approved for mCSPC, castration-resistant prostate cancer, and non-metastatic castration-sensitive prostate cancer with a high risk of metastasis.

Neal Shore from the Carolina Urologic Research Center, who was involved in the study, highlighted that randomized and controlled phase 3 studies have long been the benchmark for comparing the efficacy of oncology medications. However, prospective ARPI comparator trials had not been performed previously. Shore noted that this real-world study is significant because it provides robust data and insightful methodology that can offer prescribers valuable information regarding overall survival, aiding in their choice of ARPI.

Adding to the commentary, Luca Dezzani, US Vice President for Medical Affairs in Solid Tumours at J&J Innovative Medicine, remarked that the company has advanced the field with this new evidence demonstrating the overall survival benefit provided by Erleada.