Maintenance therapy with the PARP inhibitor fuzuloparib considerably extended progression-free survival in women newly diagnosed with advanced ovarian cancer, a phase 3 trial showed-but adding the anti-angiogenic drug apatinib didn’t offer any additional benefit.
Although frontline maintenance treatment with fuzuloparib monotherapy produced a progression-free survival (PFS) benefit in patients with newly diagnosed advanced ovarian cancer, the addition of apatinib to fuzuloparib did not significantly improve PFS, according to the final analysis of the phase 3 FZOCUS‐1 study (NCT04229615).
at a median follow-up of 40 months, the median PFS among patients who received fuzuloparib monotherapy (n = 269) was 29.9 months (95% CI, 22.1-36.1) compared with 11.1 months (95% CI,8.3-16.6) among those who received placebo (n = 136; HR, 0.58; 95% CI, 0.44-0.75; 1-sided P < .0001). The median PFS among patients who received fuzuloparib in combination with apatinib (n = 269) was 26.9 months (95% CI, 20.3-36.6),conferring a PFS HR of 0.57 (95% CI, 0.44-0.75; 1-sided P < .0001) compared with the placebo arm.
“To our knowledge,this study is the first to indicate that the addition of an antiangiogenic agent [in this case,apatinib] to a PARP inhibitor [in this case,fuzuloparib] does not improve PFS among patients who have BRCA‐mutated or homologous recombination deficiency-positive [HRD] ovarian cancer,” Lingying Wu,MD,of the National Cancer Centre/National Clinical Research Center for Cancer/Cancer Hospital,chinese Academy of Medical Sciences and Peking Union Medical College,in Beijing,China and the study coauthors wrote in the publication.
Fuzuloparib was approved in China in december 2020 for the treatment of patients with platinum-sensitive recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer harboring a BRCA mutation following second-line or later chemotherapy. The agent was subsequently approved in China for the frontline maintenance treatment of patients with advanced ovarian cancer based on prior data from the interim analysis of FZOCUS‐1.
How was the FZOCUS‐1 Study Designed?
FZOCUS‐1 was a multicenter, 2-stage study that enrolled patients wh
References
- Wu L, Wang J, Li Q, et al. Fuzuloparib with or without apatinib as maintenance therapy in newly diagnosed, advanced ovarian cancer (FZOCUS-1): a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. CA Cancer J Clin. 2026;76(1):e70042. doi:10.3322/caac.70042
- Lee A. fuzuloparib: first approval. Drugs. 2021;81(10):1221-1226. doi:10.1007/s40265-021-01541-x
