Monday, October 17, 2022

Niraparib Maintenance Provides Durable Long-term Remission in High-Risk Advanced Ovarian Cancer

 This is an edited version of an article written by Kristi Rosa and published in OncLive Sept. 15, 2022

Maintenance treatment with niraparib (Zejula) produced a sustained and durable progression-free survival (PFS) benefit in patients with primary advanced ovarian cancer who responded to first-line platinum-based chemotherapy, spanning biomarker subgroups, according to updated data from the phase 3 PRIMA trial....

Data presented during the 2022 ESMO Congress showed that at a median follow-up of 3.5 years, which had a data cutoff date of November 17, 2021, the median progression-free survival (PFS) with niraparib was 24.5 months per investigator assessment vs 11.2 months with placebo in the homologous recombination deficiency (HRD) population....

In the overall population (n = 733), the median investigator-assessed PFS with niraparib was 13.8 months vs 8.2 months with placebo....

Treatment with niraparib boosted the duration of PFS vs placebo across the biomarker subgroups examined. The greatest benefit was observed in those with HRD tumors that were BRCA mutated....

“Sustained benefit was observed with long-term follow-up, with hazard ratios that were consistent with the primary analysis regardless of biomarker status,” lead study author Antonio Gonz├ílez-Martin, of Medical Oncology Department, Clinica Universidad de Navarra, and colleagues, wrote in a poster on the data. “In the HRD and homologous recombination–proficient [HRp] populations, respectively, a clinically meaningful 48% and 35% reduction of the risk of progression or death was observed.”

The randomized, double-blind, placebo-controlled, phase 3 trial enrolled patients with newly diagnosed ovarian cancer who were at high risk for recurrence following response to frontline platinum-based chemotherapy....

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