Janssen announces positive Phase III results for prostate cancer drug apalutamide

pharmafile | February 10, 2021 | News story | Research and Development Cancer, Janssen 

Final results from Janssen’s Phase III TITAN study have shown its cancer drug apalutamide improved overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) when combined with androgen deprivation therapy (ADT), compared with placebo plus ADT.

With nearly four years of median follow-up, data from the final analysis of the Phase III study confirmed that apalutamide plus ADT provided statistically significant improvement in OS, with a 35% reduction in risk of death compared to ADT alone.

There was consistent benefit across other endpoints, including improved second progression-free survival and delayed time to castration resistance. Additionally, health-related quality of life, per total Functional Assessment of Cancer Therapy-Prostate, continued to be maintained in both groups. The safety of apalutamide was consistent with previously reported studies, and observed adverse events included skin rash, fracture, and falls.

To date, published results on apalutamide include data from more than 2,000 patients across Phase III clinical studies. The drug has shown a statistically significant improvement in OS with a consistent safety profile in both approved indications of mHSPC and non-metastatic castration-resistant prostate cancer.

Dr Catherine Taylor, Vice President, Medical Affairs, Therapeutic Area Strategy for Europe, Middle East and Africa at Johnson & Johnson, said: “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.

“The results of the TITAN final analysis demonstrate that apalutamide with ADT provides a new therapeutic option for people living with advanced, hormone-sensitive prostate cancer.”

Professor Axel Merseburger, Chairman of the Clinic of Urology at Universitatsklinikum Schleswig-Holstein, and investigator of the TITAN study, added: “The TITAN final analysis is a welcome development for the management of metastatic hormone-sensitive-prostate cancer, as the data show us that apalutamide with ADT improves long-term clinical benefit and prolonged overall survival, without compromising health-related quality of life for these patients.

“The results also demonstrate an established safety profile which is encouraging for the management of patients living with advanced forms of prostate cancer.”

Darcy Jimenez

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