Long-term Erleada patient-reported outcomes data in metastatic castration-sensitive prostate cancer shows maintenance of health-related quality of life for patients.- Janssen Pharmaceutical companies

The Janssen Pharmaceutical Companies of Johnson & Johnson announced patient-reported outcomes (PRO) data from the pre-specified final analysis of the Phase III TITAN study in patients with metastatic castration-sensitive prostate cancer (mCSPC) . The TITAN study previously demonstrated statistically significant improvement in overall survival (OS) after a median follow-up of 44 months in patients receiving Erleada plus androgen deprivation therapy (ADT). The new PRO data showed that the addition of Erleada to ADT maintained patients’ health-related quality of life (HRQoL) and did not worsen side effect burden, consistent with ADT alone.These data are being presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8 (Abstract #5068). No significant differences in quality of life were observed between patients who received Erleada plus ADT and patients who received placebo plus ADT. Overall, patients in both groups reported being relatively asymptomatic with a good baseline HRQoL; the outcomes were assessed using the Brief Pain Inventory-Short Form (BPI-SF) and Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaires. 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 Erleada 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 Erleada group and 113.3 in the placebo plus ADT group. Erleada plus ADT was also shown to maintain physical, social and family, emotional, functional, and mental well-being 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 Erleada. Erleada has previously shown a statistically significant improvement in OS for both of its approved indications in prostate cancer, specifically mCSPC (TITAN study) 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 Erleada to ADT continued to provide statistically significant OS benefit after 44 months in patients with mCSPC. Erleada plus ADT reduced the risk of death by 35 percent compared with ADT alone (hazard ratio [HR]=0.65; 95 percent confidence interval [CI], 0.53-0.79; P<0.0001). spartan final analysis data were presented at the 2020 asco annual meeting, showing that erleada plus adt prolonged median os by 14 months (73.9 vs. 59.9 months median os for erleada and placebo groups, respectively) and reduced the risk of death by 22 percent (hr="0.78;" 95 percent ci, 0.64-0.96; p="0.016)." see- agarwal, n. et al. "health-related quality of life (hrqol) and patient-reported outcomes at final analysis of the titan study of apalutamide (apa) versus placebo (pbo) in patients (pts) with metastatic castration-sensitive prostate cancer (mcspc) receiving androgen deprivation therapy (adt)". https: meetinglibrary.asco.org record 197750 abstract. see- chi, k, et al. "apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, phase iii titan study". journal of clinical oncology. accessed may 2021.></0.0001).>