PRIMA Post-Clinical Analysis Results, Disease Progression and Death Risk Reduction
Takeda Pharmaceutical Korea announced on the 23rd that it has reconfirmed the effect of maintenance therapy in ovarian cancer patients with a high risk of recurrence through a post-clinical analysis of the ovarian cancer drug Zejula (ingredient name niraparib) in PRIMA.
The results of this post-mortem analysis were presented at the American Society of Gynecologic Oncology (SGO) meeting held on the 19th to 25th.
The PRIMA clinical study is a double-blind, randomized, phase 3 clinical study that evaluated the efficacy of Zejula in 733 adult patients with ovarian cancer newly diagnosed with ovarian cancer.
In this post-analysis, the effectiveness of Jejula was confirmed by dividing patient cases by the time of operation and the presence of residual diseases, reflecting the characteristics of ovarian cancer diseases with high recurrence rates.
The study found that Zejula reduced the risk of disease progression and death by 59% in ovarian cancer patients with visible residual disease (VRD) who underwent additional tumor reduction surgery (IDS).
The risk of disease progression and death is 42% in patients with ovarian cancer who have undergone primary debulking surgery (PDS) and have visible residual disease, and the risk of disease progression and death in patients who have undergone additional tumor reduction surgery and no visible residual disease. It was reduced by 35%.
Professor Kim Jae-won of the Department of Obstetrics and Gynecology of Seoul National University Hospital said, “Ovarian cancer is found in the 3rd to 4th stage because there is no symptom, and more than 80% of patients experience recurrence. “The treatment method must be considered.”
“Jejula is a primary and secondary maintenance therapy that can be used regardless of biomarkers in all patients, and is a PARP inhibitor approved as a 4 or more treatment regimen. Through this post-analysis, high-risk ovarian cancer patients with high risk of recurrence It has also been confirmed that it is a drug that can expect an innovative maintenance therapy treatment effect,” said Professor Kim, who said, “We expect it will continue to play a pivotal role in the domestic ovarian cancer treatment environment.”
Copyright holder © Uihyeop Shinmun Unauthorized reproduction and redistribution prohibited