(Ovarian Cancer) Is Zejula Effective?

On July 13, 2023, Ning Li et al. from the Chinese Academy of Medical Sciences and Peking Union Medical College published results from the PRIME Phase III clinical trial in JAMA Oncology, evaluating the efficacy and safety of Zejula (niraparib) as maintenance therapy in advanced ovarian cancer.

The PRIME Phase III trial was a multicenter, randomized, double-blind trial that assigned advanced ovarian cancer patients receiving first-line platinum-based chemotherapy in a 2:1 ratio to either the Zejula group or the placebo group. The primary endpoint was progression-free survival (PFS).

Patient median ages (384 patients): Zejula group 53 years (range 32-77) and placebo group 54 years (range 33-77).

The median PFS (primary endpoint) for all patients was 24.8 months for the Zejula group vs. 8.3 months for the placebo group. For patients with germline BRCA mutations, median PFS was not reached for the Zejula group vs. 10.8 months for the placebo group. For germline BRCA mutation-negative patients, median PFS was 19.3 months for the Zejula group vs. 8.3 months for the placebo group. For HRR gene-deficient patients, median PFS was not reached for the Zejula group vs. 11.8 months for the placebo group. For HRR gene-proficient patients, median PFS was 16.6 months for the Zejula group vs. 5.5 months for the placebo group.

Based on the PRIME trial results, Ning Li et al. stated: "Zejula as maintenance therapy for advanced ovarian cancer improved progression-free survival."

Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00276-0/fulltext#%20

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