The final analysis of Janssen’s phase 3 TITAN study has demonstrated continued overall survival (OS) benefit of Erleada plus androgen deprivation therapy (ADT) in certain prostate cancer patients.
The TITAN study evaluated Erleada (apalutamide) plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to placebo plus ADT.
The new data, which includes nearly four years of median follow-up, demonstrated a 35% reduction in the risk of death in mHSPC patients receiving Erleada plus ADT compared to ADT alone.
In addition, Janssen – the pharmaceutical division of Johnson & Johnson – reported consistent benefits across other endpoints, such as second progression-free survival (PFS) and delayed time to castration resistance.
“Janssen is committed to uncovering new solutions for patients with prostate cancer as, until very recently, there has been little advancement in treatment options for people with metastatic hormone-sensitive prostate cancer,” said Catherine Taylor, vice-president, medical affairs therapeutic area strategy for Europe, Middle East and Africa, Johnson & Johnson Middle East.
“The results of the TITAN final analysis demonstrate that Erleada with ADT provides a new therapeutic option for people living with advanced, hormone-sensitive prostate cancer,” she added.
In the EU, Erleada is approved for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC).
Initial results from the TITAN study found that Erleada plus ADT led to a 33% reduction in the risk of death in mHSPC patients, although median OS had not been reached at that time.
Androgen inhibitor Erleada (apalutamide) is Janssen’s follow-up to its older, blockbuster prostate cancer drug Zytiga (abiraterone acetate), which has now been hit by the loss of patent protection and generic competition.
Pfizer/Astellas’ prostate cancer treatment Xtandi (enzalutamide) is also a prominent market competitor, with approvals in nmCRPC, mCSPC and metastatic castration-resistant prostate cancer (mCRPC).
Bayer/Orion’s Nubeqa (darolutamide) is a more recent competitor and it has been approved for the treatment of nmCRPC in men.
This approval is based on results from the phase 3 ARAMIS trial that compared Nubeqa to placebo when given as an add-on to androgen deprivation therapy (ADT).
Nubeqa demonstrated a significant improvement in metastasis-free survival in the treatment arm, with a median of 40.4 months compared to 18.4 months in the placebo plus ADT arm.