GSK’s ovarian cancer treatment gains successful results in latest trial
GSK announced results from its PRIMA Phase III trial, in which 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 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, niraparib, 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 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; however GSK says it will share these data with the relevant health authorities and is on track to file by the end of the year.
Around 300,000 women are diagnosed with ovarian cancer each yearand it 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.