GlaxoSmithKline has announced positive headline results from its Phase III PRIMA study of Zejula (niraparib) for patients with ovarian cancer in the first line maintenance setting.
The drug was found to demonstrate significant improvement in progression free survival for women regardless of their biomarker status.
The exciting data “demonstrate that ZEJULA has the potential to significantly benefit even more women with this devastating cancer’” said Dr Hal Baron.
Last month the US Food and Drug Administration (FDA) accepted the company’s application and granted Priority Review for the drug, with Mary Lynne Hedley, president and chief operating officer of Tesaro, saying that the results of the QUADRA study “demonstrate that Zejula is active as a late-line treatment for patients beyond those with BRCA mutations. With this study, we continue to advance our mission to provide more patients with ovarian cancer an opportunity to benefit from treatment with Zejula.”
The National Institute of Health and Care Excellence recommended the drug via the Cancer Drug Fund (CDF) for women with a BRCA mutation who have received two lines of chemotherapy and in women without a BRCA mutation who have received two or more lines of chemotherapy, while further data was collected.
In the UK, ovarian cancer has the highest mortality rate of all gynecological cancers. It has one of the highest incidence rates in Europe with survival rates among the lowest. The rate of newly diagnosed cases of ovarian cancer in the UK is 16 per 100,000 of the population compared to the European average of 12.6 per 100,0005. Every year 4,100 women lose their lives to ovarian cancer - 11 women every day.
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 safety and tolerability profile of the treatment was consistent with previous clinical trials.