GlaxoSmithKline has announced results from its PRIMA Phase III trial, in which Zejula (niraparib) was studied as a maintenance therapy in women with first-line ovarian cancer following a response to platinum-based chemotherapy.
The data showed that treatment with the drug resulted in a 38% reduction in the risk of disease progression or death in the overall population, driven by a clinically meaningful reduction in risk of progression in women with BRCA mutation tumours, HR-deficient BRCA wild type tumours and HR-proficient tumours.
The drug in question, Zejula, is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Dr. Antonio Gonzalez, co-director, department of medical oncology, Clinica Universidad de Navarra, and primary investigator for PRIMA said that the study “demonstrated the importance of maintenance therapy and the benefit that niraparib provided to women with ovarian cancer,” before going on to say that he believes “niraparib monotherapy after surgery and platinum-based chemotherapy could be an important new treatment option for patients.”
The therapy is not currently approved in the first-line ovarian cancer maintenance setting, but GSK says it will share these data with the relevant health authorities and is on track to file by the end of the year.
Approximately 300,000 women are diagnosed with ovarian cancer each year. Ovarian cancer is the eighth most frequent cause of cancer death among women and despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years.
The results were presented at the European Society for Medical Oncology (ESMO) Congress 2019.