First-in-China PARP Dual-Action Combination Therapy Approved: Niraparib/Abiraterone Reduces Risk of Progression or Death by 45% in BRCA-Mutated mCRPC

Niraparib and Abiraterone Tablets (Zejula® & Zytiga®, AKEEGA®) is a highly selective PARP inhibitor composed of niraparib and abiraterone. It is the first and currently the only orally administered Dual Action Tablet (DAT) that can simultaneously target two oncogenic drivers in patients with mCRPC: BRCA1/2 mutations and the androgen receptor axis.

Among them, Niraparib was approved by the U.S. FDA in March 2017 for the treatment of recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. Abiraterone, on the other hand, is an androgen synthesis inhibitor that suppresses the production of the CYP17 enzyme complex, reducing the levels of androgens in the body.

Johnson & Johnson announced in August 2023 the latest clinical research results of "Niraparib Abiraterone Tablets + Prednisone in combination therapy for metastatic castration-resistant prostate cancer," with data simultaneously published in the *Annals of Oncology*.

A total of 423 metastatic castration-resistant prostate cancer (mCRPC) patients with homologous recombination repair (HRR) alterations ≥1 were enrolled in this study. They were randomly divided into two groups at a 1:1 ratio: the Niraparib group (Niraparib Abiraterone Tablets + Prednisone) and the control group (Placebo + Prednisone). The results are as follows:

1、Radiographic Progression-Free Survival (rPFS): The median rPFS was19.5 months (Niraparib group) vs 10.9 months (Control group). Obviously, compared with the placebo group,Niraparib Abiraterone Tablets Significantly Extended Patients' Median rPFS by 8.6 Months(See the figure below for details).

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2、Risk of Disease Progression or Death Plummets: Compared with patients treated with placebo + prednisone (AAP),Niraparib Abiraterone Tablets Reduced the Risk of Disease Progression or Death by a Full 45% in Patients[HR=0.55 (95% CI range: 0.39–0.78)].

Believe that after seeing the data above, patients with metastatic prostate cancer must have ignited new hope! The good news is that China is currently conducting clinical research on "Abiraterone Acetate and Prednisone with or without Abemaciclib," and a large number of patients have successfully joined the treatment through the Global Oncology Doctors Network's new cancer drug recruitment center! This also means that patients in China now have the opportunity to receive this "new" anti-cancer drug treatment for free!

Indications

Patients with metastatic castration-resistant prostate cancer who are treatment-naive.

Recruitment Information (Partial)

1) Prostate adenocarcinoma confirmed by histological diagnosis.

2) Metastatic prostate cancer confirmed by measurable soft tissue metastatic lesions shown on positive bone scan and/or computed tomography (CT) or magnetic resonance imaging (MRI).

3. At the time of entering the study, there was confirmed disease progression during continuous ADT treatment and/or after orchiectomy, defined as the appearance of one or more of the following: ≥2 new bone lesions, with or without PSA progression.

4) Be able and willing to accept mandatory biopsy of at least one tumor metastasis site.

Application Process

Patients who wish to apply for this clinical trial need to submit their treatment history, recent pathology, and genetic testing reports, etc., to the Medical Department of Global Oncology Doctors Network (you can call directly).Medical Department 4006667998; or send the photo to the email:doctor.huang@globecancer.com, and leave contact information in the email).

Experts from the Medical Department will provide you with a comprehensive analysis and interpretation of the test report, and will contact you by phone within 1 working day to recommend new drugs and medication plans, as well as match suitable clinical trial projects for enrollment. As a leading platform for cancer patients in China, Global Cancer Doctors Network commits to keeping all participants' personal information confidential and guarantees adherence to China’s laws and regulations related to clinical research throughout the entire process.

Prostate cancer, one of the most common cancers in the male urinary and reproductive systems, has seen a continuously rising incidence rate in China in recent years. Among these patients, approximately 10% to 15% carry BRCA 1/2 gene mutations. Apart from Johnson & Johnson's Niraparib Abiraterone Tablets mentioned in this article, multiple targeted drugs for BRCA 1/2 mutations have been approved for marketing or are currently undergoing clinical research. Cancer patients who are unsatisfied with their current treatment or wish to participate in clinical trials for new drugs can submit their treatment history, discharge summary, recent pathology, and imaging examination reports toGlobal Oncology Doctors Network Medical Department (4006667998), conduct a detailed evaluation, or seek opportunities for free medication through the Ark Program!

#Ark Gene Treasure Plan#

"Ark Gene Treasure Plan" is a gene "treasure hunt" initiative launched by Global Cancer Doctors Network in collaboration with Cancer-Free Home, authoritative gene testing institutions, international pharmaceutical companies, and renowned cancer centers. This program aims to thoroughly explore the survival hopes indicated in each gene testing report, comprehensively interpret the gene testing reports for cancer patients, and match cancer patients globally with suitable marketed new drugs and clinical trials of investigational drugs, seeking new survival opportunities and chances for free treatment with both marketed and unmarketed new drugs!

Patients who wish to participate can send their genetic test reports and diagnosis reports electronically.Subsidiary or BrandIlluminateSend to: doctor.huang@globecancer.com. Leave contact information in the email, and the Medical Department will contact you by phone within 1 working day after receiving and analyzing the report; or call directly.Global Oncology Doctors Network Medical Department (400-666-7998)Evaluation.

This article is original from Global Oncologist Network. Reprinting is strictly prohibited without authorization.

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