Johnson & Johnson (J&J) has reported positive results from a real-world, head-to-head study evaluating Erleada (apalutamide) in patients with metastatic castration-sensitive prostate cancer (mCSPC).
Erleada is an androgen receptor inhibitor approved for treating non-metastatic castration-resistant prostate cancer (nmCRPC) and mCSPC.
It received approval from the US Food and Drug Administration (FDA) for nmCRPC in February 2018 and for mCSPC in September 2019.
The latest trial involved nearly 4,000 patients, making it the largest real-world, head-to-head analysis of these two androgen receptor pathway inhibitors (ARPIs) in mCSPC, Johnson & Johnson said.
According to the findings, apalutamide showed a notable overall survival benefit at 24 months compared to enzalutamide in mCSPC patients.
The analysis found that patients who initiated Erleada had a statistically significant 23% lower risk of death at 24 months compared to those on enzalutamide.
In this real-world study, 87.6% of Erleada patients were alive at 24 months, aligning with results from the Phase 3 TITAN trial, which reported 82.4%.
The TITAN trial demonstrated a significant overall survival benefit for the androgen receptor inhibitor with androgen deprivation therapy (ADT) in comparison to ADT alone.
Johnson & Johnson innovative medicine solid tumours medical affairs US vice president Luca Dezzani said: “Erleada is the only ARPI to demonstrate a survival benefit as early as 22 months, as seen in the TITAN study.
“Since Erleada’s approval, multiple ARPIs have been introduced, but no one has directly compared their effectiveness on a large scale, until now.”
Currently, apalutamide is being assessed in the Phase 3 ATLAS and PROTEUS trials for localised high-risk or locally advanced prostate cancer.
Earlier this week, Johnson & Johnson announced a $2bn biologics manufacturing facility in Wilson, North Carolina. This facility will enhance the production of innovative biologics for oncology, immunology, and neuroscience.
It will also support the pharma major’s broader plan to advance over 70 novel therapy and product expansion filings and launches by the end of 2030.
Construction is set to begin in the first half of 2025. Upon completion, the facility is expected to generate around 420 full-time jobs.
