Final TITAN analysis confirms survival benefit of J&J's Erleada in prostate cancer

Johnson & Johnson's Janssen Pharmaceutical unit reported results from a final analysis of the Phase III TITAN study, with data showing that Erleada (apalutamide) continued to demonstrate a significant overall survival (OS) benefit in patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of extent of disease. The findings are scheduled to be presented at the American Society of Clinical Oncology's genitourinary (ASCO GU) cancers symposium.

Initial trial results announced in 2019 showed that after a median follow-up of 22.7 months, the addition of Erleada to androgen deprivation therapy (ADT) significantly improved OS, with a 33% reduction in the risk of death, whilst also lowering the risk of radiographic progression or death by 52%. The findings were used to support expanded FDA approval of the androgen receptor inhibitor to include the treatment of patients with mCSPC.

Risk of death cut by 35%

The latest data demonstrated that with nearly four years of median follow-up, Erleada plus ADT was associated with a 35% reduction in risk of death versus ADT alone, with 48-month survival rates of 65% and 52%, respectively. Janssen added that the improvement in OS increased to a 48% reduction in risk of death after adjusting for the almost 40% of placebo patients who crossed over to the Erleada group. Kim Chi, principal investigator of the TITAN study, remarked "based on these data, ADT alone should no longer be considered sufficient for patients with advanced, castration-sensitive disease."

The trial randomised 1052 patients with mCSPC to receive ADT in combination with either Erleada or placebo. The study's dual primary endpoints were OS and radiographic progression-free survival (rPFS), while secondary goals include time to cytotoxic chemotherapy, time to pain progression, time to chronic opioid use, and time to skeletal-related events. According to Janssen, there was "consistent benefit" across the secondary endpoints, as well as exploratory goals, including second PFS and delayed castration resistance.

Erleada, which first gained clearance in the US in 2018 for the treatment of patients with non-metastatic CSPC, generated sales of $241 million in the fourth quarter of last year.