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Fuzuloparib extended PFS vs placebo regardless of the addition of apatinib in newly diagnosed advanced ovarian cancer.
Frontline maintenance treatment with fuzuloparib monotherapy produced a progression-free survival (PFS) benefit vs placebo in patients with newly diagnosed advanced ovarian cancer; however, the addition of apatinib to fuzuloparib did not significantly improve PFS vs placebo, according to data from the final analysis of the phase 3 FZOCUS‐1 study (NCT04229615) published in CA: A Cancer Journal for Clinicians.1
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 Center/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.
In December 2020, fuzuloparib was approved in China 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.2 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‐1.1
FZOCUS‐1 was a multicenter, 2-stage study that enrolled patients who were 18 to 75 years of age with newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer. Patients were also required to have stage III or IV disease, undergone primary debulking surgery or neoadjuvant therapy with interval debulking surgery, received 6 to 9 cycles of platinum-based chemotherapy and experienced a complete or partial response, an ECOG performance status of 0 or 1, and adequate organ function.
Patients were randomly assigned 2:2:1 to receive oral fuzuloparib at 100 mg twice daily plus oral apatinib at 375 mg daily, oral fuzuloparib at 150 mg twice daily, or matching placebo. Study treatment was administered in all patients no later than 12 weeks following the completion of the final dose of platinum-based chemotherapy.
The primary end point was PFS per blinded independent central review. Secondary end points included investigator-assessed PFS, overall survival (OS), best overall response, time to disease progression, time to study treatment discontinuation or death, time to first subsequent therapy or death, time to second progression, chemotherapy‐free interval as safety and tolerability, and patient‐reported outcomes.
At baseline, the median age in the overall population was 54 years (range, 29-75). Most patients had HRD disease (72.1%), undergone primary debulking surgery (57.1%), and achieved R0 resection following cytoreduction (55.6%). BRCA1/2 mutations were present in 31.5% of patients.
Additional findings from FZOCUS-1 revealed that the median OS was not reached in any of the 3 treatment arms. The 36-month OS rates in the monotherapy, combination, and placebo arms were 77.0% (95% CI, 71.3%-81.7%), 78.9% (95% CI, 73.3%-83.4%), and 76.6% (95% CI, 68.2%-83.0%), respectively.
In terms of safety, patients in the combination, monotherapy, and placebo arms experienced treatment-related adverse effects (TRAEs) at respective rates of 97.8%, 98.9%, and 94.1%. Grade 3 or higher TRAEs occurred at rates of 48.7%, 45.7%, and 7.4%, respectively.
“The AE profile of fuzuloparib monotherapy was in line with the safety data reported in previous fuzuloparib trials,” the study authors wrote. “TRAEs of grade 3 or higher were mainly hematological toxicities. Anemia, neutropenia, and thrombocytopenia were common AEs associated with PARP inhibitors. The incidence of hypertension and proteinuria was higher in the fuzuloparib plus apatinib group than the fuzuloparib group, which can be attributed to the addition of apatinib.”
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