The FZOCUS-1 study, led by Chinese researchers, has been published in the globally renowned oncology journal *CA: A Cancer Journal for Clinicians* (impact factor: 232.4). This marks the first time *CA* has featured a clinical study in gynecologic oncology conducted by Chinese researchers.
FZOCUS-1 is a six-year, randomized, double-blind, placebo-controlled Phase III clinical trial conducted across 54 centers in China, involving 674 patients. The study evaluated the efficacy and safety of HENGRUI PHARMA's self-developed PARP inhibitor, fuzuloparib (used alone or in combination with the anti-angiogenic drug apatinib), as first-line maintenance therapy for advanced ovarian cancer.
Key findings include: - Patients receiving fuzuloparib monotherapy achieved a median progression-free survival (PFS) of 29.9 months, showing significant statistical improvement over the placebo group. - In the BRCA-mutated subgroup, fuzuloparib extended median PFS from 16.6 months (placebo) to 47.8 months, substantially reducing the risk of disease progression or death. - For HRD-positive patients, the study confirmed that PARP inhibitor monotherapy delivers optimal efficacy while avoiding the side effects and financial burden of combination therapies.
Professor Wu Lingying, principal investigator of FZOCUS-1 and a researcher at the Chinese Academy of Medical Sciences Cancer Hospital, stated, "The publication of FZOCUS-1 in *CA* is a major milestone for China’s clinical oncology research. This study—from design to execution and data analysis—was independently completed by a Chinese team, with all evidence derived from Chinese patients. Its value lies not only in providing high-level treatment options for Chinese patients but also in contributing critical 'China data' and 'China wisdom' to global ovarian cancer care."
Wang Quanren, Vice President of HENGRUI PHARMA, emphasized, "The success of FZOCUS-1 reflects our commitment to 'science-driven innovation for healthier lives.' Fuzuloparib’s journey—from laboratory discovery to international academic recognition—demonstrates how Chinese pharmaceutical companies can address global clinical challenges through independent R&D. We are proud that this 'Made-in-China' innovation is transitioning from 'serving Chinese patients' to 'benefiting global health.'" He added, "Fuzuloparib is now covered by China’s national medical insurance, significantly improving accessibility. We are working to ensure more ovarian cancer patients can afford this high-quality innovative treatment."
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