Results from the Phase III TITAN study final analysis have confirmed the survival benefit achieved with the addition of apalutamide to androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer.
The Janssen Pharmaceutical Companies of Johnson & Johnson have reported positive patient-reported outcomes (PRO) data from the pre-specified final analysis of the Phase III TITAN study in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The TITAN study previously demonstrated improvement in overall survival after a median follow-up of 44 months in patients receiving apalutamide plus androgen deprivation therapy (ADT). The new PRO data showed that the addition of apalutamide to ADT maintained patients’ health-related quality of life and did not worsen side effect burden, consistent with ADT alone.
The data are being presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, in June.
Apalutamide and androgen deprivation therapy
Health-related quality of inpatients who received apalutamide plus ADT and patients who received placebo plus ADT, was maintained throughout the study.
Outcomes were assessed using the Brief Pain Inventory-Short Form (BPI-SF) and Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaires. The results showed that on the BPI pain severity scale of zero (no pain/interference in daily activities) to 10 (worst pain/interference), median patient scores were 1.1 in the apalutamide group and one in the placebo plus ADT group.
On the FACT-P health-related quality of life scale (one to 156, whereby a higher score equals better quality of life), median patient scores were 113 in the apalutamide group and 113.3 in the placebo plus ADT group.
Furthermore, apalutamide plus ADT was also shown to maintain physical, social, family, emotional, functional, and mental wellbeing beyond two years, as assessed by FACT-P. There were no significant differences between groups in median time to deterioration in any BPI or FACT-P scores, further demonstrating maintenance of quality of life with apalutamide.
Professor Axel Merseburger, M.D., PhD, Chairman of the Clinic of Urology at University Hospital Schleswig-Holstein in Lübeck and investigator for TITAN, said: “Patients are often concerned about the added burden of side effects in their disease management. The latest findings from the TITAN clinical trial show us how we can improve patient overall survival without compromising on quality of life, an important step in the right direction for improved advanced prostate cancer care.”
Apalutamide has previously shown improvement in overall survival for both of its approved indications in prostate cancer, specifically mHSPC and non-metastatic castration-resistant prostate cancer (SPARTAN study). The TITAN final analysis data, presented at the 2021 ASCO Genitourinary Cancers Symposium and recently published in the Journal of Clinical Oncology, reaffirmed that the addition of apalutamide to ADT continued to provide overall survival benefit after 44 months in patients with mHSPC. Apalutamide plus ADT also reduced the risk of death by 35% compared with ADT alone.
“We are pleased to be able to share the patient reported outcome results from the TITAN study at ASCO this year. We know they are essential in providing meaningful context on the patient experience of treatment with apalutamide plus androgen deprivation therapy for metastatic hormone-sensitive prostate cancer that enable healthcare professionals to make informed treatment decisions that are right for individual patients,” said Dr Catherine Taylor, EMEA Vice-president, Medical Affairs Therapy Area Strategy for Europe, Middle East and Africa, Johnson & Johnson Middle East FZ-LLC. “These findings, along with the overall survival benefit, provide further evidence on apalutamide plus ADT as a first-line, therapeutic option for people living with mHSPC.”