Janssen Announces ERLEADA® (apalutamide) Significantly Extends Overall Survival in Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Feb 13, 2021 03:14 CST Updated 03:14

Johnson & Johnson

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Janssen Pharmaceuticals

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February 13, 2021 News /BioonBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently at the American Clinical held from February 11-13, 2021TumorThe final analysis results of the Phase III TITAN study were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU 2021), with data showing that in patients with metastatic castration-sensitive prostate cancer (mCSPC),Regardless of disease severity, compared with placebo plus androgen deprivation therapy (ADT),Erleada® (apalutamide) in combination with ADT demonstrated a statistically significant benefit in overall survival (OS).

TITAN was a randomized, placebo-controlled, double-blind study conducted in patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of disease volume or prior docetaxel treatment history. A total of 1,050 patients were enrolled in the intention-to-treat (ITT) population, including those with low-volume and high-volume disease, newly diagnosed patients, and patients who had previously received definitive local therapy or up to 6 cycles of docetaxel or up to 6 months of androgen deprivation therapy (ADT) for mCSPC. These patients were randomly assigned to receive either Erleada plus ADT (n=525) or placebo plus ADT (n=527) until disease progression, unacceptable treatment-related toxicity, or end of treatment.

The preliminary results of this study were presented at the 2019 American ClinicalTumorPresented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU 2019) and published in The New England Journal of Medicine, the results demonstrated that, in patients with metastatic castration-sensitive prostate cancer (mCSPC), Erleada plus androgen deprivation therapy (ADT) significantly improved the co-primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) compared with placebo plus ADT: (1) a 33% significant reduction in the risk of death (HR=0.67, p=0.005); and (2) a 52% significant reduction in the risk of radiographic progression or death.

The final analysis data presented at this conference showed that, after a median follow-up of nearly 4 years, Erleada + ADT demonstrated a statistically significant improvement in overall survival (OS) compared with placebo + ADT, reducing the risk of death by 35% (HR=0.65, p<0.0001). These results were consistent with the primary analysis of the TITAN study, despite up to 40% of patients in the placebo group subsequently crossing over to receive Erleada treatment. After adjusting for crossovers, the improvement in OS was greater, with a 48% reduction in the risk of death (HR=0.52, p<0.0001).

Consistent efficacy was observed across other endpoints, including improvement in second progression-free survival (PFS2) (HR=0.62; p<0.0001) and delayed onset of castration-resistant prostate cancer (HR=0.34; p<0.0001). Furthermore, Erleada continued to maintain health-related quality of life (HRQoL), as assessed by the Functional Assessment of Cancer Therapy–Prostate (FACT-P). The safety and tolerability profile of Erleada was consistent with previously reported studies.

Prostate Cancer (Image source: hopkinsmedicine.org)

Principal Investigator of the TITAN Study, BC Cancer Centre, VancouverTumorDr. Kim Chi stated, “The final analysis of the TITAN study further confirms that treatment with Erleada prolongs overall survival (OS) and provides clear long-term clinical benefits and safety for patients with metastatic prostate cancer who are initiating androgen deprivation therapy. Based on these data, ADT alone should no longer be considered an adequate treatment for patients with advanced castration-sensitive disease.”

Mary Guckert, Vice President of Prostate Cancer Research and Development Lead at Janssen, stated, “The final analysis data from the TITAN study confirmed the long-term clinical benefits and consistent safety profile of Erleada plus ADT, without compromising health-related quality of life. The results demonstrated the consistency and durability of Erleada in advanced prostate cancer, highlighting how Erleada addresses critical unmet needs.”

To date, the published results for Erleada include data from more than 2,000 patients in Phase 3 clinical studies. Erleada has demonstrated a statistically significant improvement in overall survival (OS) and a consistent safety profile in its two approved indications: metastatic castration-sensitive prostate cancer (mCSPC, TITAN study) and non-metastatic castration-resistant prostate cancer (nmCRPC, SPARTAN study). Currently, Erleada has been approved in more than 70 countries worldwide, and global labeling is being updated to reflect the final analysis data from the TITAN study.

Erleada is a next-generation androgen receptor (AR) inhibitor that helps block the activity of male hormones (such as testosterone), thereby delaying disease progression. In the United States, Erleada received its initial FDA approval 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 first drug worldwide for the treatment of nmCRPC. In September 2019,FDAApproval of a new indication for Erleada for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

In China, Erleada® (ANSENKE®) 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 ANSENKE® “Priority Review” status due to its significant clinical advantage and included it in the second batch of the List of Overseas New Drugs Urgently Needed for Clinical Use. ANSENKE® is the first approved treatment regimen for nmCRPC in China and represents another innovative solution brought by Janssen Pharmaceuticals to the field of prostate cancer in China, 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 metastatic castration-resistant prostate cancer (mCRPC) and newly diagnosed high-risk metastatic castration-sensitive prostate cancer (mCSPC).

In August 2020, the National Medical Products Administration (NMPA) approved a new indication for Erleada® (Ansenke®) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Notably, in February 2020, the mHSPC indication for Ansenke® was 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 holds a very positive outlook on the commercial prospects of Erleada. According to forecast reports released by the pharmaceutical market research firm EvaluatePharma, global sales of Erleada are projected to reach $2.115 billion in 2024. (Bioon.com)

Original Source: Janssen Announces Treatment with ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer