Janssen Announces China Approval of First PARP Inhibitor Combination Therapy for BRCA-Mutated mCRPC

Oct 21, 2024 11:31 CST Updated 11:31

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

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Today(October 21)，Johnson & Johnson announced that its development ofNiraparib Abiraterone TabletsThe new drug marketing application has been approved.National Medical Products Administration (NMPA)Official Approval, used forCombined with prednisone or prednisolone for the treatment of patients carrying germline and/or somatic mutationsBRCAAdult patients with metastatic castration-resistant prostate cancer (mCRPC) harboring gene mutations.Public information shows that this is a product byPARP Inhibitor NiraparibAndAndrogen Biosynthesis Inhibitor AbirateroneCompound therapy consisting of.

Prostate cancer is a type of malignant tumor commonly diagnosed in men. Most men are diagnosed with localized prostate cancer, which can be treated with surgery or radiation therapy. The growth of prostate cancer cells is androgen-dependent, so patients are initially sensitive to androgen deprivation therapy (ADT). However, patients who experience disease progression despite continuous ADT will develop metastatic castration-resistant prostate cancer (mCRPC). It is estimated that approximately 10% to 50% of patients progress to mCRPC within three years after diagnosis, among whom about 10% to 15% carryBRCAGene mutation.

Niraparib（niraparib）It is a once-daily oral PARP1/2 inhibitor that has been approved in the United States, the European Union, and China for the treatment of advanced ovarian cancer and is currently being developed in clinical trials for prostate cancer treatment. In 2016, Johnson & Johnson reached an agreement with TESARO (which has since been acquired by GlaxoSmithKline) to study the efficacy of this product in treating prostate cancer. That same year, Zai Lab also entered into a strategic cooperation agreement with TESARO, obtaining exclusive rights for the research, development, and sales of niraparib in the Chinese market.Abiraterone is aAndrogen Synthesis Inhibitor, which can inhibit the production of the CYP17 enzyme complex, thereby reducing androgen production in the body.

Johnson & Johnson's press release introduced the combination of niraparib and abiraterone with prednisone or prednisolone as a highly selective PARP inhibitor., which can target two oncogenic drivers in mCRPC patients — the androgen receptor axis andBRCA1/2Mutation。

Previously, the combination of niraparib and abiraterone acetate tablets demonstrated positive results in a Phase 3, randomized, double-blind, placebo-controlled multicenter clinical trial named MAGNITUDE.This trial evaluated the combination therapy with prednisone (AAP).First-line treatment for mCRPC patients with or without homologous recombination repair (HRR)-related gene mutationsSafety and efficacy, the primary endpoint is the investigator-assessed all HRR-positive patients and those carryingBRCAThe radiographic progression-free survival (rPFS) of patients with mutations after receiving niraparib acetate abiraterone tablets combined with prednisone treatment.

According toJohnson & JohnsonResearch results published in August 2023,Receiving niraparib acetate abiraterone tablets + prednisone combination therapyBRCAPositive PatientTherPFS was significantly reduced by 47%.. At the time of the second interim analysis,BRCAThe median follow-up time for the positive subgroup was 24.8 months, and patients receiving the combination therapy showed a consistent rPFS trend.The median rPFS was 19.5 months., while the median rPFS in the control group was 10.9 months. In addition, compared with the control group, improvements were observed in the Niraparib Acetate Abiraterone Tablets + Prednisone group for secondary endpoints including Time to Symptom Progression (TSP), Time to Initiation of Cytotoxic Chemotherapy (TCC), and Overall Survival (OS). The safety profile of the combination therapy of Niraparib Acetate Abiraterone Tablets + Prednisone observed in the trial was consistent with the known safety profiles of each approved monotherapy.

References:

[1] Johnson & Johnson announces the approval of Zebec® in China, the first and currently only compound formulation for treating BRCA-mutated metastatic castration-resistant prostate cancer.. Retrieved Oct 21，2024. From https://mp.weixin.qq.com/s/OcKhwHkGOvKywFjws4OxIQ

[2]U.S. FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer. Retrieved August 11, 2023 from https://www.janssen.com/fda-approves-akeega-niraparib-and-abiraterone-acetate-first-and-only-dual-action-tablet

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