Long-Term ERLEADA® (Apalutamide) Treatment in Metastatic Castration-Sensitive Prostate Cancer Demonstrates Significant Survival Benefit and Sustained Quality of Life

May 27, 2021 /BioonBIOON/ -- Janssen Pharmaceuticals, a Johnson & Johnson (JNJ) company, recently announced patient-reported outcome (PRO) data from the pre-specified final analysis of the Phase III TITAN study evaluating the prostate cancer drug Erleada® (apalutamide) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC). Previous study results showed that:At a median follow-up of 44 months, patients treated with Erleada plus ADT demonstrated a statistically significant benefit in overall survival (OS) compared with patients receiving placebo plus ADT.. New PRO data show,The addition of Erleada to ADT maintained patients' health-related quality of life (HRQoL) and did not exacerbate the burden of side effects, consistent with ADT alone.。

Erleada is a next-generation androgen receptor (AR) inhibitor that helps block the activity of male hormones (such as testosterone) to delay disease progression. For prostate cancer, Erleada has been approved for two indications: the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC).These two indications have been approved in China.

Neeraj Agarwal, MD, principal investigator of the TITAN trial and at the Huntsman Cancer Institute (HCI) at the University of Utah, stated: “When considering treatment options, concerns about side effects and their burden on quality of life can be a barrier for patients. The significant long-term overall survival benefit we have observed with Erleada, without an impact on patients’ quality of life, underscores the important role of this therapy in the treatment of advanced prostate cancer.”

Prostate cancer (Image source: hopkinsmedicine.org)

Compared with the placebo + ADT group, patients in the Erleada + ADT group showed no significant difference in quality of life. Overall, patients in both groups reported being relatively asymptomatic with good baseline HRQoL; outcomes were assessed using the Brief Pain Inventory-Short Form (BPI-SF) and the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. On the BPI pain severity scale ranging from 0 (no pain/interference in daily activities) to 10 (worst pain/interference), the median score was 1.1 for the Erleada + ADT group and 1.0 for the placebo + ADT group. On the FACT-P HRQoL scale (1–156, higher score = better quality of life), the median score was 113 for the Erleada + ADT group and 113.3 for the placebo + ADT group. Furthermore, FACT-P assessments demonstrated that Erleada + ADT maintained physical, social and family, emotional, functional, and psychological well-being at 2 years. The median time to deterioration in BPI or FACT-P scores did not differ significantly between groups, further supporting the ability of Erleada to maintain quality of life.

Prior data have demonstrated that Erleada yielded a statistically significant improvement in overall survival (OS) in its two approved prostate cancer indications (mCSPC [TITAN study], nmCRPC [SPARTAN study]). The final analysis data from the TITAN study, presented at the 2021 ASCO Genitourinary Cancers Symposium, were recently published in *ClinicalTumorIn the *Journal of Clinical Oncology*, it was reaffirmed that adding Erleada to ADT for the treatment of patients with mCSPC continues to provide a statistically significant OS benefit after 44 months of follow-up, reducing the risk of death by 35% compared with ADT alone (HR=0.65; 95% CI: 0.53–0.79; p<0.0001). The final analysis data from the SPARTAN study, presented at the 2020 ASCO Annual Meeting, demonstrated that the Erleada + ADT regimen extended median OS by 14 months compared with placebo + ADT (Erleada group vs. placebo group: 73.9 months vs. 59.9 months) and reduced the risk of death by 22% (HR=0.78; 95% CI: 0.64–0.96; p=0.016).

Mary Guckert, Vice President, Prostate Cancer at Janssen Research & Development, said: “Patient-Reported Outcome (PRO) data provide meaningful information for treatment decisions by giving us insight into how patients feel and function. In patients with metastatic castration-sensitive prostate cancer, it is critical to offer a treatment (such as Erleada) that provides a significant survival advantage while maintaining quality of life.”

Erleada is a next-generation androgen receptor (AR) inhibitor that helps block the activity of androgens (such as testosterone), thereby delaying disease progression. In the United States, Erleada was first approved by the FDA in February 2018 for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis. This approval made Erleada the world's first drug for the treatment of nmCRPC. In September 2019,FDAApproved a new indication for Erleada for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

In China, Erleada® received accelerated approval in September 2019 for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis. In May 2019, the Center for Drug Evaluation (CDE) of the National Medical Products Administration granted Erleada® "Priority Review" status due to its significant clinical advantages and included it in the second batch of the List of Overseas New Drugs Urgently Needed for Clinical Use. Erleada® is the first approved treatment regimen for nmCRPC in China and represents another innovative solution brought to the prostate cancer field in China by Janssen Pharmaceuticals following Zytiga® (abiraterone acetate tablets). Previously, Zytiga® was approved in 2015 and 2018, respectively, for use in combination with prednisone or prednisolone to treat patients with mCRPC and newDiagnosishigh-risk mCSPC patients.

In August 2020, a new indication for Erleada® was approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Notably, in February 2020, the mHSPC indication for Erleada® was once again granted "Priority Review" status by the NMPA. The approval of this indication is expected to address the urgent unmet medical needs of patients with advanced prostate cancer in China.

The industry is highly optimistic about the commercial prospects of Erleada. According to a forecast report released by pharmaceutical market research firm EvaluatePharma, Erleada's global sales in 2024 are projected to reach $2.115 billion. (Bioon.com)

Original Source: Long-Term ERLEADA® (apalutamide) Patient-Reported Outcomes Data in Metastatic Castration-Sensitive Prostate Cancer Demonstrate Maintenance of Health-Related Quality of Life for Patients