GSK’s Zejula slows disease progression in a range of ovarian cancers
pharmafile | October 2, 2019 | News story | Research and Development | Cancer, ESMO 2019, GSK, Zejula, ovarian cancer, pharma
At the 2019 European Society for Medical Oncology (ESMO) congress, GlaxoSmithKline unveiled new Phase 3 data on Zejula (niraparib) for the maintenance of first-line ovarian cancer that has responded to platinum-based chemotherapy.
The data revealed that the drug improved progression-free survival (PFS) by 38% in the overall population of the PRIMA study. Within sub-populations of this overall group, the drug was found to improve PFS by 60% in BRCA mutation tumours, 50% in HR-deficient BRCA wild type tumours, and 32% in HR-proficient tumours
In an interim analysis, Zejula was also observed to present an “encouraging trend” towards improvement in patients’ overall survival, with 91% of HR-deficient patients still alive after 24 months compared to 85% with placebo and 81% of HR-proficient patients still alive following the same period compared to 59% with placebo. While these results were promising, they had not reached maturity and so their clinical significance is not fully known.
Dr Hal Barron, Chief Scientific Officer and President R&D at GSK, commented: “Ovarian cancer is the eighth most commonly occurring cancer in women worldwide and women with this devastating disease have a five-year survival rate of less than 50%. PRIMA is a landmark study as we believe these data have the potential to fundamentally change how women with ovarian cancer are treated.”
Zejula is not currently approved in this indication, but GSK confirmed it would be submitting these data to health authorities around the world by the year’s end.
Matt Fellows
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