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NORA trial - Niraparib favorable OS in patients with platinum sensitive recurrent ovarian cancer

Oncologyme  /  Mar 26, 2023

#Niraparib maintenance provides a favorable OS trend compared with placebo in patients with platinum sensitive recurrent ovarian cancer regardless of the #BRCA mutation status.

NORA trial is a Chinese randomized, phase 3 trial that enrolled 265 patients with platinum sensitive disease who achieved a CR or PR to the last platinum-based chemotherapy. Patients were randomized (2:1) to receive maintenance niraparib or placebo.

After median follow-up of 45 months (44% maturity), median OS was numerically longer for patients receiving niraparib versus placebo in the ITT population: 46.3 versus 43.4 mos [HR =0.826; 95% CI, 0.56-1.21] although 43% of patients in the placebo arm received subsequent PARPi therapy. Additionally, A consistent OS trend was observed by censoring patients receiving PARPi in placebo arm, regardless of gBRCA status