Chinese gynaecological experts with new advances in ovarian cancer research landed in ESMO, patients have a new standard of treatment.

September 19, 2020, at the just-held 2020 European Society of Oncology (ESMO) Conference, led by Professor Wu Xiaohua, Director of Gynaecology department of Fudan University-affiliated Oncology Hospital and chief expert in comprehensive treatment of gynaecological oncology, a joint effort of more than 30 cancer hospitals across the country The Ovarian Cancer Heavy Study "Nirapa's Phase 3 Clinical Study NORA, which uses the maintenance treatment of patients with platinum-sensitive relapsed ovarian cancer in China", was published in the full oral report (LBA29), making it the only Chinese women's tumor study selected for the full oral report this year, and has received wide attention from international women's tumor scholars.
This is the first time in recent years that a clinical study of local ovarian cancer PARP inhibitors, led by Chinese clinical experts, has published its core results to international scholars at the ESMO Conference in the form of a full oral report, and the first time in the world that the individualized starting dose of Nirapali has been used in patients with platinum-sensitive relapsed ovarian cancer. Step confirms the clinical benefits and safety of Nirapali's individualized starting dose for maintenance treatment in patients with ovarian cancer, and is also another strong confirmation of Nirapali's benefits to the whole population in platinum-sensitive recurrence ovarian cancer maintenance therapy, which is expected to have a significant impact on the clinical practice of ovarian cancer treatment in China and more regions.
as the first new class 1 drug PARP inhibitor in China, in addition to the platinum-sensitive recurrence of ovarian cancer maintenance treatment, in September this year, Erle? (Nirapali) has also been approved in China for advanced epitheliotic ovarian cancer, fallopian tube cancer or primary peritoneal cancer adult patients with first-line platinum-containing chemotherapy to achieve complete or partial remission maintenance treatment.
So far, Nirapali has become the only approved PARP inhibitor in China and the world for first-line and relapsed ovarian cancer maintenance treatment regardless of the status of the patient's biomarker, which also means that the first-line maintenance treatment of ovarian cancer has entered the whole population era, truly benefiting all patients.
breakthrough with Nirapali, China's ovarian cancer maintenance treatment has local evidence! The Nirapali NORA study, which was included in ESMO's full oral report, is the first Phase III randomized, double-blind, placebo-controlled study of PARP inhibitors for ovarian cancer maintenance therapy in China, and is an important study in the field of ovarian cancer supported by the national "13th Five-Year Plan" and "major new drug creation" technology.
NORA study represents the highest level of evidence-based medical evidence for PARP inhibitors used in patients with platinum-sensitive relapsed ovarian cancer in China.
study randomly assigned 265 patients to nirapali or placebo in a 2:1 ratio until the disease progressed.
the study assessed the effectiveness of Nirapali as a maintenance therapy, with the primary study ending with a progress-free lifetime (PFS) assessed by the Independent Blind Center.
patients with baseline weight ≥77kg and plate plate plate count ≥150K/μL starting at 300 mg, the remaining patients were treated at a starting dose of 200 mg.
results showed that receiving Nirapali maintenance therapy reduced the risk of disease progress or death by 68% in the general population (PFS HR0.32; 95% CI, 0.23-0.45; p.lt;0.0001).
compared to the placebo group, nirapali treatment significantly extended the patient's mid-level progression-free survival (PFS) by 18.3 months compared to 5.4 months.
, as of the time of analysis, 43% of patients in the Nirapali group had no disease progression, while 13% in the placebo group! In addition, in patients with gBRCA mutations, the risk of disease progression or death was reduced by 78% in patients treated with nirapali (PFS HR 0.22; 95% CI, 0.12-0.39; p.lt;0.0001); In patients without the gBRCA mutation group, the risk of disease progression or death was reduced by 60% in patients treated with nirapali (PFS HR 0.40; 95% CI, 0.26-0.61; p.lt; 0.0001), with a medium PFS of 11.1 months in Nirapali group and 3.9 months in the placebo group.
's a start! Individualized starting dose therapy is expected to affect the international clinical practice ovarian cancer is one of the biggest threats to women's health, mortality rate is the first gynaecological malignancies.
advanced ovarian cancer is the main cause of cancer death in women, after the completion of standard first-line platinum chemotherapy, the recurrence rate is still as high as 85%.
In recent years, the emergence and application of PARP inhibitors has led to the change of treatment of advanced ovarian cancer, the treatment of ovarian cancer has gradually entered the era of precision medicine, and parp inhibitors have become the standard maintenance treatment for advanced ovarian cancer.
, how to individually apply PARP inhibitors in Chinese women, while ensuring efficacy and reducing adverse reactions, has also become a new clinical focus.
, based on China's national conditions and past practical applications in patients around the world, the NORA study forward-lookingly adopted an individualized starting dose therapy based on weight and/or plate plateboard counting.
study confirmed that in patients in the Nirapali treatment group and the placebo group, the rates of hematological adverse events such as neural granulocyte count reduction events, anemia events, and plate plate count reduction events were 20.3 percent to 8.0 percent, 14.7 percent to 2.3 percent, and 11.3 percent to 1.1 percent, respectively.
Xiaohua Wu, lead researcher at NORA, said: "Nirapali's individualized starting dose programme has significant clinical benefits and good safety tolerance.
For the Chinese mainland, this 'Chinese characteristics' study of the Chinese patient population, led by our Chinese clinical experts, enriches the Chinese group data of Nirapali maintenance therapy, which means that the standardized maintenance treatment of ovarian cancer, which is more in line with the characteristics of the Chinese people, will be 'chaptered'.
the other hand, for international clinical practice, NORA research can help international experts and scholars to further optimize the application of PARP inhibitors in ovarian cancer patients, and is expected to change the way international standards of treatment have been used in the past.
under the guidance of individual precision medicine, individualized starting dose of Nirapali treatment should be considered as the standard clinical practice for maintaining treatment for ovarian cancer patients worldwide.
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