Results from the phase 3 TITAN study shows a combination therapy that includes apalutamide may achieve survival benefit without significant burden of adverse effects.
Data from a recent phase 3 study has demonstrated a survival benefit of apalutamide (Erleada; Janssen Pharmaceutical Companies) plus androgen deprivation therapy (ADT) for patients with metastatic castration-sensitive prostate cancer (mCSPC).1 Final analysis of data from the TITAN study (NCT02489318) also showed a survival benefit from the combination therapy without significant patient-reported adverse effects, compared to placebo plus ADT, as well as maintenance of health-related quality of life (HRQoL).2
Apalutamide is an oral androgen receptor inhibitor that is FDA-approved for the treatment of patients with mCSPC and for patients with non-metastatic castration-resistant prostate cancer (nmCRPC).2 Scheduled to be presented during the virtual 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8, the latest results of the TITAN study are consistent with previous data for adverse effects with only ADT.1,2
"Concern about [adverse] effects and their resulting burden on quality of life can be a barrier for patients when considering treatment options," said Neeraj Agarwal, MD, of the University of Utah Huntsman Cancer Institute in Salt Lake City, and the lead investigator for the TITAN study, in a prepared statement. "The significant long-term overall survival benefit we've seen demonstrated with [apalutamide], with no impact on quality of life as reported by patients, underscores the important role of this therapy in the treatment of advanced prostate cancer."
According to Janssen, the TITAN study included 1052 patients with mCSPC in 23 countries across 260 sites. Patients were randomized equally to groups receiving apalutamide or placebo, with both groups also receiving ADT.1,2 No significant differences in quality of life were observed between patients who received apalutamide plus ADT, and patients who received placebo plus ADT.2
Patients in both groups were assessed using the Brief Pain Inventory (BPI)-Short Form and Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaires. Those assessments revealed that patients reported they were relatively asymptomatic with a good baseline HRQoL.2
On the BPI pain severity scale of 0 (no pain) to 10 (worst pain), median patient scores were 1.1 in the apalutamide group and 1 in the placebo plus ADT group. On the FACT-P HRQoL scale (1-156, higher score = better quality of life), median patient scores were 113 in the apalutamide group and 113.3 in the placebo plus ADT group.2
Apalutamide plus ADT was also shown to help maintain physical, social and family, emotional, functional, and mental well-being beyond 2 years, as assessed by FACT-P. According to Janssen, 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.2
"Patient-reported outcomes provide meaningful input into treatment decisions by giving us insights into the way patients feel and function," said Mary Guckert, RN, MSN, vice president, development leader, prostate cancer, Janssen Research & Development, LLC, in a prepared statement.