Janssen Announces Final Phase 3 TITAN Trial Results Showing ERLEADA (apalutamide) Reduces Risk of Death by 35% in Metastatic Castration-Sensitive Prostate Cancer

Today, Janssen, a subsidiary of Johnson & Johnson, announced the final analysis results from the Phase 3 TITAN clinical trial of its prostate cancer therapy Erleada (apalutamide). The trial results demonstrated that adding Erleada to androgen deprivation therapy (ADT) significantly improved overall survival (OS) in patients with metastatic castration-sensitive prostate cancer (mCSPC), compared with placebo.

Prostate cancer is the second most common malignancy in men worldwide. Over the past decade, the incidence of prostate cancer in China has been on the rise, and it has now become the fifth most common cancer among Chinese men. Metastatic castration-sensitive prostate cancer (mCSPC) refers to prostate cancer that remains responsive to androgen deprivation therapy (ADT) but has spread to other parts of the body. Androgen deprivation therapy has long been the standard first-line treatment for advanced metastatic prostate cancer; however, nearly all cases of hormone-sensitive prostate cancer (HSPC) initially responsive to castration therapy eventually progress to castration-resistant prostate cancer (CRPC). Once CRPC develops, the prognosis is poor; therefore, delaying the progression to castration resistance is a crucial therapeutic strategy.

Erleada is a second-generation non-steroidal androgen receptor inhibitor that blocks the effects of androgens and inhibits tumor growth. It has received FDA approval for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

Final analysis results showed that at a median follow-up of nearly 4 years, Erleada plus ADT reduced the risk of death by 35% compared with ADT alone (HR=0.65, p<0.0001). In this Phase 3 clinical trial, patients who received placebo after unblinding were allowed to cross over to the Erleada group. When accounting for patients in the placebo group who crossed over to the Erleada group, the improvement in overall survival corresponded to a 48% reduction in the risk of death.

“The final analysis of TITAN further confirms that Erleada treatment can prolong overall survival and provide clear long-term clinical benefits along with a well-established safety profile for patients with metastatic prostate cancer who are initiating androgen deprivation therapy,” said Dr. Kim Chi, medical oncologist at BC Cancer in British Columbia, Canada, and principal investigator of the TITAN study.

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed hospital.

References:

[1] Janssen Announces Treatment with ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. Retrieved February 8, 2021, from https://www.prnewswire.com/news-releases/janssen-announces-treatment-with-erleada-apalutamide-significantly-improved-overall-survival-in-patients-with-metastatic-castration-sensitive-prostate-cancer-301224286.html

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