Janssen's PARP Combination Tablet Approved in China; BeiGene's Bispecific Anti-Cancer New Drug Granted IND; Bristol Myers Squibb's Opdivo plus Yervoy Receives New Indication Approval in China

Oct 22, 2024 19:40 CST Updated 19:40

Johnson & Johnson

Medical Device R&D and Manufacturer

BeOne

Developer of Molecular Targeted and Immune Anti-Tumor Drugs

Johnson & Johnson's PARP Combination Tablet Approved for Marketing in China

On October 21, Johnson & Johnson announced that the combination drug Niraparib and Abiraterone Acetate Tablets (brand name: Zebeke) has officially been approved by the National Medical Products Administration for use in combination with prednisone or prednisolone as a first-line treatment for adult patients with metastatic castration-resistant prostate cancer (mCRPC) carrying BRCA1/2 mutations.

As a highly selective PARP inhibitor, the combination of niraparib and abiraterone with prednisone or prednisolone can target two oncogenic drivers in mCRPC patients—the androgen receptor axis and BRCA1/2 mutations.

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. The study enrolled a total of 423 patients (including 225 patients with BRCA mutations), with the primary endpoint being radiographic progression-free survival (rPFS). The first interim analysis showed a significant extension in rPFS for HRR-positive patients (16.5 vs. 13.7 months; HR=0.73). In patients with BRCA1/2 mutations, the rPFS was significantly prolonged in the niraparib plus AAP group (16.6 vs. 10.9 months; HR=0.53). By the second interim analysis, the rPFS in patients with BRCA1/2 mutations had extended to 19.5 months.

BeOne Medicines' Bispecific Antibody Cancer Class 1 New Drug Approved for Clinical Trials in China

On October 22, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that BeOne Medicines' Class 1 new drug, BGB-B3227 for injection, has been approved for clinical trials, intended for the development of treatment for advanced or metastatic solid tumors. According to publicly available information from BeOne Medicines, BGB-B3227 is a MUC1/CD16A bispecific antibody and is one of the company’s early-stage product pipelines in the pan-tumor field. This marks the first time the product has received IND approval in China.

Clinicaltrials.gov information shows that a study of BGB-B3227 alone and in combination with the PD-1 inhibitor tislelizumab for the treatment of advanced or metastatic solid tumors has been initiated in the United States this August. The study is expected to be completed by early 2027.

The approval of BGB-B3227 for clinical use in China marks a new advancement in BeOne Medicines' early-stage molecular pipeline for solid tumors.

Bristol-Myers SquibbOpdivo Combined with Yervoy New Indication Approved in China for First-Line Treatment of Colorectal Cancer

On October 14, Bristol-Myers Squibb announced that the dual immunotherapy combination of Opdivo (nivolumab injection) and Yervoy (ipilimumab injection) has been approved by the China National Medical Products Administration (NMPA) for a new indication, indicated for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer (CRC).

This approval for the colorectal cancer indication in China precedes that of the United States, the European Union, Japan, and other countries and regions, marking the first time it has been officially approved by a health regulatory authority globally.

This approval is based on the CheckMate -8HW study, the first Phase III trial to demonstrate that dual immunotherapy combination provides significant clinical benefits compared to standard chemotherapy as a first-line treatment for patients with MSI-H/dMMR metastatic colorectal cancer (mCRC). According to blinded independent central review (BICR) assessment, in the primary endpoint of progression-free survival (PFS), Opdivo combined with Yervoy showed statistically and clinically significant improvement over investigator-selected chemotherapy regimens, reducing the risk of disease progression or death by 79% (hazard ratio [HR]=0.21, p<0.0001). At 24 months, the PFS rate was 72% in the Opdivo plus Yervoy group, compared to only 14% in the chemotherapy group. Consistent benefits were observed across all predefined subgroups treated with Opdivo plus Yervoy, including patients with RAS and BRAF mutations, as well as those with liver, lung, or peritoneal metastases at baseline. The safety profile of Opdivo plus Yervoy was favorable in the study, with no new safety signals identified. The incidence of grade 3/4 treatment-related adverse events (TRAEs) was 23% for Opdivo plus Yervoy, compared to 48% for chemotherapy.