Johnson & Johnson (J&J) has announced results from a real-world study comparing its Erleada (apalutamide) to Pfizer and Astellas’ Xtandi (enzalutamide) in patients with metastatic castration-sensitive prostate cancer (mCSPC).
The head-to-head study looked at data from more than 3,700 patients treated with the androgen receptor pathway inhibitors (ARPIs) and found that Erleada provided a statistically significant overall survival benefit at 24 months compared to Xtandi.
The results presented at the European Congress of Oncology Pharmacy showed that patients who received Erleada as their first ARPI had a 23% reduction in their risk of death at 24 months compared to patients whose first ARPI therapy was Xtandi, with 87.6% of Erleada-treated patients alive at the two year mark.
J&J said the result were consistent with those observed in the late-stage TITAN trial, in which Erleada in combination with androgen deprivation therapy (ADT) showed a statistically significant superior overall survival benefit compared to ADT alone after a median 22.7 months of follow-up and then after a median 44 months.
Approximately 300,000 new cases of prostate cancer are diagnosed in the US every year and, despite advancements in treatment, disease recurrence remains substantial.
Erleada is already approved by the US Food and Drug Administration to treat both mCSPC and non-metastatic castration-resistant prostate cancer, while Xtandi has been approved by the regulator for mCSPC, castration-resistant prostate cancer and non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
Study investigator Neal Shore, Carolina Urologic Research Center, noted that while head-to-head, randomised and controlled phase 3 studies have been the “gold standard” for comparing the effectiveness of oncology medicines, prospective ARPI comparator trials have not previously been conducted.
“This real-world study is provocative as the comprehensive data and rigorous methodology used in this study offers real-world insights on overall survival which can provide prescribers with information to consider when choosing an ARPI,” he said.
Luca Dezzani, US vice president, medical affairs, solid tumours, J&J Innovative Medicine, added that the company has “pushed the field further with this additional evidence showing an overall survival benefit with Erleada”.