The results of phase 2 of the single-drug treatment of ovarian cancer, Hengrui Pharmaceutical Fluorine Paley, were published

Recently, Clinical Cancer Research published the full online results of the single-arm, multi-center Phase 2 clinical study of the treatment of BRCA1/2 mutant relapsed ovarian cancer.
study was led by Professor Wu Lingying of the Oncology Hospital of the Chinese Academy of Medical Sciences and involved 26 research institutions in China.
results show that fluorozopa, which is used in patients with relapsed ovarian cancer with BRCA1/2 mutations, shows promising anti-tumor activity and acceptable safety and is expected to provide a new treatment option for this population.
fluorine Pali is a polyadenosine disphosphate cytolytase (PARP) inhibitor developed by Hengrui Pharmaceuticals that specifically kills tumor cells with BRCA mutations.
in many ovarian cancer patients, harmful BRCA1 and BRCA2 mutations can occur, affecting DNA repair.
PARP inhibitors, through the "synthetic death" mechanism, effectively inhibit the repair of tumor cell DNA damage, promote tumor apoptosis, and significantly prolong the survival of ovarian cancer patients.
In December 2020, fluoroopapari was approved by China's State Drug Administration (NMPA) through a priority review process for the treatment of patients with platinum-sensitive relapsed ovarian, fallopian or primary peritoneal cancers with embryoline BRCA mutations (gBRCAm) who have underwent second-line and above chemotherapy.
the drug became the first PARP inhibitor to be approved in China and developed by a Chinese company.
the study, published in the Journal of Clinical Cancer Research, included 113 patients with relapsed ovarian cancer with BRCA1/2 pathogenic and suspected pathogenic mutations who had received 2 to 4 treatments with platinum-containing programs in the past.
patients were given oral fluoroporapali twice a day for 150 mg for 28 days for a dosing cycle.
end points of the study were objective mitigation rates (ORRs) assessed by the Independent Review Committee (IRC) based on the RECIST v1.1 criteria, and secondary study endpoints included mitigation duration (DoR), progress-free lifetime (PFS), and so on.
as of March 21, 2020, the medium follow-up time was 15.9 months.
results showed that ORR assessed by IRC and researchers was 69.9% (95% CI: 60.6-78.2) and 70.8% (95% CI: 61.5-79.0), respectively.
in all pre-defined subgroups, the objective mitigation rate is similar.
PFS assessed by IRC and evaluated by researchers was 12.0 months (95% CI:9.3-13.9) and 10.3 months (95% CI:9.2-12.0), respectively.
12-month survival rate was 93.7% (95% CI: 87.2-96.9).
In terms of safety, the study observed that 63.7% (72/113) of patients had adverse reactions of magnitude 3 or above, the most common of which was a decrease in anemia/hemoglobin, a lower rate of adverse gastrointestinal reactions at level 3 and above, and only 1 patient had a termination of treatment due to adverse drug reactions.
overall, patients with relapsed ovarian cancer with the BRCA1/2 mutation showed promising anti-tumor activity and acceptable safety.
the study's lead researcher, Professor Wu Lingying, said a number of patients had benefited from the study,according to a Henrui Pharmaceuticals press release.
72.6% of patients were partially platinum-sensitive relapses, i.e. within 6 to 12 months of the most recent chemotherapy.
this group of patients with platinum-containing chemotherapy is not only less effective, but also accumulates more toxic side effects.
and fluorine parri is used at this time, not only to treat the effect, compared with chemotherapy, but also to improve the quality of life of patients.
it is worth mentioning that fluoroazole palladium has reached the end of its main study in 2020 in a Phase 3 clinical study (FZPL-III-301-OC) for the maintenance of relapsed ovarian cancer.
results show that the maintenance therapy of platinum-sensitive relapsed ovarian cancer, fallopian tube cancer or primary peritoneal cancer with platinum after complete or partial remission can significantly prolong the patient's progressive survival.
based on this result, Hengrui Pharmaceuticals has submitted an application to NMPA for the listing of a new fluorine parri adaptive disorder and has been included in the NMPA's priority review.
addition, Hengrui Pharmaceuticals is also conducting studies on the effectiveness of fluorine palipate monodharmaceuticals and combined apatinib for maintenance therapy after first-line platinum-containing chemotherapy for advanced ovarian cancer.
are expected to prove efficacy in a wider range of ovarian cancer patients, helping to truly contribute to the recurrence of ovarian cancer, according to the company's press release.
ovarian cancer is one of the most prevalent gynaecological tumors in China.
most ovarian cancer patients inevitably relapse, although they are relieved after initial platinum-containing chemotherapy.
and options for the treatment of platinum-sensitive relapsed ovarian cancer are still very limited.
, PARP inhibitors have become the standard treatment for ovarian cancer, which is consistently recommended by guidelines both inside and outside China.
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