Presented by the American Gynecological Oncology Association, reconfirmed the effectiveness of maintenance
[팜뉴스=김민건 기자] It was confirmed that Takeda Pharmaceutical Korea’s ovarian cancer drug’Jejula (Niraparip)’ reduced the risk of disease progression and death by 59% in high-risk ovarian cancer patients who received additional tumor reduction surgery and had visible residual disease.
Takeda Pharmaceutical (CEO Hee-Seok Moon) announced on the 23rd that it has confirmed the effectiveness of maintenance therapy in ovarian cancer patients with high risk of recurrence through PRIMA Post Hoc analysis of PARP inhibitor Zejula.
Jejula is the only drug that can be taken once a day among the first PARP inhibitors available regardless of BRCA mutations.
The results of this PRIMA post-clinical analysis were presented at the American Society of Gynecologic Oncology (SGO) meeting held from the 19th to the 25th of this month.
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 consideration of the high recurrence rate of ovarian cancer due to the nature of ovarian cancer, the post-mortem analysis of PRIMA, which was released this time, confirmed the effectiveness of Jejula by dividing patient cases in detail by the time of operation and the presence of residual diseases.
The study found that Jejula reduced the risk of disease progression and death by 59% in ovarian cancer patients with visible residual disease (VRD) who received additional tumor reduction surgery (IDS).
This patient group is known to be the most difficult to treat among newly diagnosed ovarian cancer patients because of the highest risk of recurrence.
In addition, Jejula reduced the risk of disease progression and death by 42% in ovarian cancer patients with visible residual disease after undergoing primary debulking surgery (PDS).
In addition, the risk of disease progression and death was reduced by 35% in patients who received additional tumor reduction surgery and no visible residual disease.
Takeda Pharmaceutical said, “It was confirmed that the effect on residual disease after initial tumor reduction surgery or additional tumor reduction surgery showed similar results between subgroups.”
Professor Kim Jae-won of the Department of Obstetrics and Gynecology at Seoul National University Hospital said, “Ovarian cancer is found in the 3rd to 4th stage because there are no symptoms. Since more than 80% of patients experience recurrence, treatment methods that can extend the patient’s life as much as possible, such as first-line treatment and maintenance therapy. Should be considered.”
In particular, Professor Kim expected that through this post-mortem analysis, Jejula would play a pivotal role in the domestic ovarian cancer treatment environment.
Professor Kim said, “If you are a high-risk patient, choosing a more innovative treatment option is important. Jejula is already a first-line and second-line maintenance therapy that can be used in all patients, regardless of biomarker,” said Professor Kim.
He added, “As it is a PARP inhibitor that has been approved as a 4th or higher treatment regimen, we have confirmed that it is a drug that can expect innovative maintenance treatment effects even in high-risk ovarian cancer patients with high risk of recurrence through this post-analysis.”
Meanwhile, Zejula was the first PARP inhibitor that can be used with or without BRCA mutations, and was approved by the U.S. FDA in March 2017. In Korea, it was first approved in March 2019. Currently, it has been approved for all stages of ovarian cancer treatment from the 1st to 4th and above, and the convenience of taking it is improved by taking it once a day.
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