A phase 2 trial of niraparib plus bevacizumab maintenance therapy following first-line platinum-based chemotherapy with bevacizumab in advanced ovarian cancer: final analysis and overall survival results from OVARIO.

OBJECTIVE

To report long-term outcomes from the OVARIO trial of niraparib plus bevacizumab maintenance following first-line platinum-based chemotherapy with bevacizumab in advanced ovarian cancer.

METHODS

The phase 2, single-arm, open-label trial enrolled adult patients with stage IIIB-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer (NCT03326193). Patients were required to have attempted debulking surgery and have a complete or partial response or no evidence of disease following first-line, platinum-based chemotherapy with ≥3 cycles of bevacizumab. The primary endpoint was 18-month progression-free survival (PFS) rate, per RECIST. Secondary endpoints included PFS, overall survival (OS), safety, and health-related quality of life (HRQOL) as assessed by the Functional Assessment of Cancer Therapy-Ovarian Symptoms Index (FOSI). Final analysis cutoff date, August 12, 2024.

RESULTS

The median duration of follow-up was 65.7 months. Among evaluable patients (N = 105), PFS results were consistent with the primary analysis. Median OS (95% CI) was 61.1 months (44.9 months-not evaluable [NE]; 52.4% maturity) in the overall population, NE (58.2 months-NE) in the homologous recombination-deficient, 38.7 months (21.9-63.8 months) in the homologous recombination-proficient, and 39.8 months (21.7 months-NE) in the homologous recombination status not determined subgroups. Most patients (73.3%) received subsequent anticancer therapy; 30.5% received subsequent PARP inhibitor therapy. No new safety signals were identified; safety remained consistent with the primary analysis. Per FOSI, HRQOL was not negatively affected.

CONCLUSION

In OVARIO, median OS was 61.1 months in the overall population. Safety was consistent with known safety profiles of niraparib and bevacizumab as monotherapies.