FDA approves niraparib for first-line maintenance of ... PDF Quality-Adjusted Time Without Symptoms or Toxicity (QA ... EP. Using PARP Inhibitors in Frontline Maintenance Therapy of Ovarian Cancer - Episode 5. Clinical Trials in Ovarian Cancer Maintenance: PRIMA and NOVA Tumor Type. The drug is also undergoing studies as a combination therapy for metastatic, triple-negative breast cancer and platinum-sensitive ovarian cancer. The ongoing development programme for niraparib includes a Phase 3 trial as first-line monotherapy maintenance treatment in patients with first-line ovarian cancer (the PRIMA trial), a Phase 3 . Therapeutic Efficacy of Niraparib. In most developed countries, it is approved as a maintenance treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients with complete or partial response to platinum-based therapy. PDF Niraparib therapy in patients with newly diagnosed ... This trial evaluated over 700 patients in a randomized . 2: Role of Maintenance Therapy in Ovarian Cancer. Overview of PARP Inhibitors in the Treatment of Ovarian Cancer The study assessed the efficacy of niraparib as maintenance treatment, as measured by progression free survival. In 2019, niraparib was approved as fourth-line therapy for women with advanced ovarian cancer with a type of DNA repair deficiency called homologous recombination deficiency ( HRD). The fi rst randomized trials to show efficacy of PARP inhibitors were these 3 maintenance treatments in recurrent ovarian cancer, and olaparib has 2 studies, Study 19 and SOLO2; niraparib has one . Niraparib for maintenance treatment of advanced ovarian ... FDA Approves Niraparib for First-Line Maintenance of ... The trial included women with and without a positive test result for certain genetic characteristics called HRD. First-line PARP inhibitors in ovarian cancer: summary of ... In the Phase III PRIMA trial, data from which supported the latest approval, advanced ovarian cancer patients were stratified based on their homologous recombination deficiency (HRD) status using Myriad Genetics' myChoice CDx. Thomas Herzog, MD. 4% of new cancers in women. The efficacy of niraparib as maintenance therapy for advanced ovarian cancer was investigated in the double-blind, placebo-controlled, multicentre phase III PRIMA trial (Fig. Prima's lead product is CVac™, an autologous dendritic cell product currently in clinical trials for ovarian cancer patients who are in remission. More and more patients with epithelial ovarian cancer will receive a PARP inhibitor as upfront therapy following positive results in the SOLO1, PAOLA-1 and the PRIMA/ENGOT-OV26/GOG-3012 studies in which olaparib prolonged the time to recurrence in BRCA1/2-mutated disease and niraparib prolonged progression-free survival time, regardless of . The study assesses the efficacy of niraparib as maintenance treatment, as measured by progression free survival. On April 29, 2020, the Food and Drug Administration approved niraparib (ZEJULA, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum . Colorectal Cancer. Bradley J. Monk, MD. Free. Patients with HR-proficient ovarian cancer have the worst prognosis.6 7 18 The results for this group of patients were different across the three randomised trials of first-line PARP inhibitors.6-8 The PAOLA-1 trial did not report any benefit of adding olaparib to bevacizumab compared with bevacizumab alone in the HRD-negative subgroup (HR 1 . N Engl J Med; Advance online publication 28 September 2019 . EP. PRIMA is a double-blind, randomized, placebo-controlled Phase 3 study of Zejula (niraparib) as a maintenance therapy in women with first-line ovarian cancer following a response to platinum-based . Apart from the PRIMA study, niraparib is being studied in the Phase III BRAVO trial for germline BRCA-mutated, metastatic breast cancer and Phase II QUADRA study in ovarian cancer patients. PRIMA Was Designed to Address the Unmet Need in 1L Advanced OC Hypothesis: PRIMA/ENGOT-OV26/GOG-3012 was designed to test the efficacy and safety of niraparib therapy after response to platinum-based chemotherapy in patients with newly diagnosed advanced ovarian cancer, including those at high risk of relapse (ClinicalTrials.gov: NCT02655016) About PRIMA PRIMA is a double-blind, randomised Phase 3 study designed to evaluate niraparib versus placebo in first-line Stage III or IV ovarian cancer patients. All Tumor Type. All of the enrolled women had at least a PR to first-line platinum‑based . Sixty three ovarian cancer patients in first or second remission have been enrolled. Gupta said the NOVA, PRIMA and QUADRA trials could lead to the adoption of PARP inhibitors across more ovarian cancer settings. The study is assessing Zejula's efficacy as maintenance treatment, as measured by progression-free survival. LBA1 - González Martín A, Pothuri B, Vergote IB, et al. 1 For many decades, the standard of care for frontline therapy for women with newly diagnosed advanced ovarian cancer has consisted of a combination of cytoreductive surgery and platinum with or without taxane-based chemotherapy. Maintenance treatment with Zejula extended the time without disease worsening in women with advanced ovarian cancer who had responded to first-line chemotherapy, according to updated results of a Phase 3 trial.. The recommended niraparib dose for first-line maintenance treatment of advanced ovarian cancer is based on body weight or platelet count. PRIMA Was Designed to Address the Unmet Need in 1L Advanced OC Hypothesis: PRIMA/ENGOT-OV26/GOG-3012 was designed to test the efficacy and safety of niraparib therapy after response to platinum-based chemotherapy in patients with newly diagnosed advanced ovarian cancer, including those at high risk of relapse (ClinicalTrials.gov: NCT02655016) . Do one ladies then have her experience in this Prima Trial and what are the results so far, side efects and more. PRIMA Clinical Trial - First Line Treatment. The researchers conducting the PRIMA trial wanted to know if the observed clinical benefit of niraparib could be extended to all patients with advanced ovarian . the patients with ovarian cancer, after a response to first-line platinum-based chemotherapy. At Sylvester, we offer multiple ovarian cancer clinical trials, including a trial combining checkpoint inhibitor (immunotherapy) with standard chemotherapy. Phase 3 PRIMA trial of Zejula® (niraparib) is the first study to show a PARP inhibitor significantly improves PFS, regardless of biomarker status, when given as monotherapy in women with first-line platinum responsive advanced ovarian cancer [news release]. Are patient-reported outcomes (PROs) similar in the placebo and the niraparib groups, suggesting that over the course of treatment niraparib does not adversely affect patients' quality of life? Issued: 28 September 2019, London UK Phase 3 PRIMA trial of Zejula® is the first study to show a PARP inhibitor significantly improves PFS, regardless of. PRIMA is an ongoing, randomized, double-blind phase III trial of niraparib 300 mg once daily vs placebo in patients with newly diagnosed ovarian cancer and a response to 6-9 cycles of first-line chemotherapy, and who are at high risk of recurrence (N = 733). 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