Zejula (niraparib) shows durable and sustained long-term progression-free survival benefit in the PRIMA study of first-line platinum-responsive advanced ovarian cancer
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HRd patients treated with Zejula were estimated to be more than twice as likely free of progression or death at four years as compared to placebo
Zejula maintained a clinically meaningful PFS benefit in newly diagnosed patients who were at high risk of early progression
GSK plc (LSE/NYSE: GSK) today announced long-term data from the phase III PRIMA (ENGOT-OV26/GOG-3012) study showing Zejula (niraparib) maintained a sustained and clinically meaningful progression-free survival (PFS) benefit as a maintenance therapy in patients with first-line ovarian cancer following a response to platinum-based chemotherapy. Importantly, this benefit was sustained across all biomarker subgroups, including BRCAm, HRd and HRp. Results from the updated efficacy analysis will be presented on 11 September at the 2022 European Society for Medical Oncology (ESMO) Annual Meeting (9-13 September).
After a median three and a half years follow up, this ad hoc analysis showed:
In the HRd population, Zejulamaintained a clinically significant risk reduction of progression or death of 48% compared to placebo (HR 0.52; 95% CI, (0.40–0.68); p<0.0001). The estimated probability of no progressive disease or death at four years was 38% for Zejula vs 17% for placebo, respectively.
Zejula maintained a durable PFS benefit in the overall population (HR 0.66; 95% CI, (0.56–0.79); p<0.0001).The estimated probability of no progressive disease or death at four years in the overall population was 24% for Zejula vs 14% for placebo, respectively.
The HRp population also demonstrated a clinically meaningful reduction in the risk of progression or death by 35% compared to placebo (HR 0.65; 95% CI, (0.49–0.87); p<0.0038).
Overall survival data are not yet mature based on the prespecified analysis plan.