Janssen-Cilag Announces Launch of Next-Generation Androgen Receptor Inhibitor Erleada® (Apalutamide) in China for High-Risk Non-Metastatic Castration-Resistant Prostate Cancer

Beijing, November 27, 2019 /PRNewswire/ -- Johnson & Johnson’s pharmaceutical subsidiary in China, Xian Janssen Pharmaceutical Ltd., announced today that its next-generation androgen receptor inhibitor, Erleada^®(Apalutamide Tablets, English brand name: Erleada^®, apalutamide) was officially launched in China for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) at high risk of metastasis^[1]. Previously, the Center for Drug Evaluation (CDE) of the National Medical Products Administration, due to Erleada^®Its significant clinical advantage granted it “Priority Review” status, and Erleada^®Included in the second batch of the List of Overseas New Drugs in Urgent Clinical Need, it became the first next-generation androgen receptor inhibitor approved in China for patients with non-metastatic castration-resistant prostate cancer.

Erleada^®As a next-generation potent androgen receptor inhibitor, it blocks the androgen signaling pathway in prostate cancer cells, inhibiting cancer cell growth through three mechanisms, thereby delaying the onset of distant metastasis.^[2]. Clinical studies have shown that Erleada^®Prostate-Specific Antigen (PSA) Levels: A Key Indicator for Early Treatment and Prognosis in Prostate Cancer Patients^[3]Has a significant controlling effect^[4], its accelerated approval and market launch have addressed the urgent clinical needs in prostate cancer, providing patients with a novel treatment option.

Over the past decade, the incidence of prostate cancer in China has been on the rise, and it is now the fifth most common cancer among Chinese men.^[5]As an androgen-dependent tumor, endocrine therapy is currently a mainstream clinical treatment option for prostate cancer, alongside radical surgery, radiation therapy, and chemotherapy. If a patient with prostate cancer experiences a rise in prostate-specific antigen (PSA) levels after undergoing androgen deprivation therapy (ADT), it may indicate diminished or lost treatment efficacy, suggesting a high probability of progression to the castration-resistant stage. Without timely intervention, nearly 90% of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) will develop bone metastases, leading to pain, fractures, and spinal cord compression.^[6], posing a serious threat to patients' lives. Although there has been some progress in the treatment of prostate cancer in recent years, metastatic castration-resistant prostate cancer remains a fatal disease.

Professor Zhou Liqun, Director of the Institute of Urology at Peking University, President of the Urology Branch of the Chinese Medical Doctor Association, and a urologist at Peking University First Hospital, pointed out: “Relevant data show that prior to the advent of novel endocrine therapies, the 5-year survival rate for patients with advanced metastatic prostate cancer was only 3%, and patients’ quality of life declined sharply as the disease progressed. Therefore, timely intervention during the non-metastatic castration-resistant prostate cancer (NM-CRPC) stage to delay metastasis and postpone progression to the metastatic castration-resistant clinical stage, which carries the worst prognosis, represents one of the key breakthroughs in prostate cancer treatment. And Erleada^®"As a novel treatment regimen, it effectively addresses the gap in the clinical management of prostate cancer in China."

Erleada^®The approval was based on a global, multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial named SPARTAN. The data showed that patients who had previously experienced rapid PSA elevation while undergoing androgen deprivation therapy, upon receiving Erleada^®Following treatment, the median metastasis-free survival (MFS) showed a statistically significant improvement, reaching 40.51 months, which represents an extension of more than 2 years (24.31 months) compared to 16.20 months in patients receiving placebo. The risk of distant metastasis or death was reduced by 72% (HR = 0.28; 95% CI, 0.23–0.35; P < 0.0001). ^[1]. Additionally, in the exploratory endpoints, Erleada^®Compared with the placebo group, the treatment group reduced the risk of PSA progression by 94% (HR = 0.06; 95% CI, 0.05-0.08; P<0.0001); 93% of patients achieved a ≥50% reduction in PSA from baseline, with a median time to 50% PSA reduction of 0.95 months.^[7],[8]

Professor Wang Jianye, Director of the National Center for Geriatrics, President of Beijing Hospital, and Chairman of the Geriatrics Branch of the Chinese Medical Association, fully affirmed Erleada.^®Highlighting its importance in the disease management and treatment of prostate cancer, he stated, “In recent years, urologists and oncologists have been continuously exploring therapeutic agents and clinical management strategies for the non-metastatic castration-resistant prostate cancer (NM-CRPC) stage, while patients have an urgent need for new regimens to delay tumor metastasis. Erleada^®“The arrival of [the drug/therapy] has, in effect, optimized the current standard of care for non-metastatic castration-resistant prostate cancer (NM-CRPC) in China, creating new opportunities for patients and their families to achieve a higher quality of life.”

Li Bin, Head of Medical Affairs at Xian Janssen, stated: “As the first approved drug for the treatment of non-metastatic castration-resistant prostate cancer, Erleada^®Its significant efficacy and safety have been fully confirmed in international and domestic clinical trials, providing a novel, safe, and effective treatment option for patients with prostate cancer.”

"As one of the deep cultivators in the field of urological oncology, Xian Janssen has always been attentive to the diverse needs of patients at various stages of prostate cancer and continues to improve their quality of life by accelerating the introduction of innovative drugs. Erleada"^®is followed by Zytiga^®“Following abiraterone acetate tablets, this is the second novel prostate cancer therapy introduced to China by Xian Janssen. Its arrival has renewed hope for survival among patients with non-metastatic castration-resistant prostate cancer and their families,” emphasized Asgar Rangoonwala, President of Xian Janssen. “We will continue to uphold our commitment to patients in China, working closely with various institutions and industry partners to enhance drug accessibility and ensure that every patient can equally benefit from pharmaceutical innovations.”

Currently, Erleada^®Has entered China, with extensive coverage in cities including Beijing, Shanghai, Guangzhou, Hangzhou, Tianjin, Xi’an, Chengdu, and Wuhan. The China Primary Health Care Foundation has officially launched the “Anmu Xinsheng” Erleada program.^®Patient Assistance Program, Helping to Improve Patient Access to Erleada^®accessibility of treatment, and has simultaneously launched a prostate cancer patient support program to provide comprehensive care and support throughout the diagnosis and treatment journey for prostate cancer patients, enabling them to benefit from long-term standardized treatment and enjoy a fulfilling life.

[1] Apalutamide Tablets Package Insert (2019)

[2] Smith, M.R., Antonarakis, E.S., Ryan, C.J. et al, Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509), a Potent Androgen Receptor Antagonist, in the High-risk Nonmetastatic Castration-resistant Prostate Cancer Cohort, European Association of Urology, 2016

[3] Smith MR, et al. Cancer Res 2012; 72(6):1494-503.

[4] China Practical Medicine Volume 31, 2014

[5] CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

[6] Saad F, et al. The 2015 CUA0CUOG guidelines for the management of castration-resistant prostate cancer (CRPC). Can Urol Assoc J. 2015;9(3-4):90-96. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4455631/. Accessed February 2018.

[7] Smith MR, et al. N Engl J Med. 2018 Apr 12; 378(15): 1408-1418.

[8] Small EJ, et al. Oral presentation at AUA 2018; abstract PD10-11.