TY - JOUR
T1 - Progression-free survival and safety at 3.5 years of follow-up
T2 - results from the randomised phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer
AU - González-Martín, Antonio
AU - Pothuri, Bhavana
AU - Vergote, Ignace
AU - Graybill, Whitney
AU - Lorusso, Domenica
AU - McCormick, Colleen C.
AU - Freyer, Gilles
AU - Backes, Floor
AU - Heitz, Florian
AU - Redondo, Andrés
AU - Moore, Richard G.
AU - Vulsteke, Christof
AU - O'Cearbhaill, Roisin E.
AU - Malinowska, Izabela A.
AU - Shtessel, Luda
AU - Compton, Natalie
AU - Mirza, Mansoor R.
AU - Monk, Bradley J.
N1 - Publisher Copyright:
© 2023 The Authors
PY - 2023/8
Y1 - 2023/8
N2 - Purpose: To report updated long-term efficacy and safety from the double-blind, placebo-controlled, phase 3 PRIMA/ENGOT-OV26/GOG-3012 study (NCT02655016). Methods: Patients with newly diagnosed advanced ovarian cancer with complete or partial response (CR or PR) to first-line platinum-based chemotherapy received niraparib or placebo once daily (2:1 ratio). Stratification factors were best response to first-line chemotherapy regimen (CR/PR), receipt of neoadjuvant chemotherapy (yes/no), and homologous recombination deficiency (HRD) status (deficient [HRd]/proficient [HRp] or not determined). Updated (ad hoc) progression-free survival (PFS) data (as of November 17, 2021) by investigator assessment (INV) are reported. Results: In 733 randomised patients (niraparib, 487; placebo, 246), median PFS follow-up was 3.5 years. Median INV-PFS was 24.5 versus 11.2 months (hazard ratio, 0.52; 95% confidence interval [CI], 0.40–0.68) in the HRd population and 13.8 versus 8.2 months (hazard ratio, 0.66; 95% CI, 0.56–0.79) in the overall population for niraparib and placebo, respectively. In the HRp population, median INV-PFS was 8.4 versus 5.4 months (hazard ratio, 0.65; 95% CI, 0.49–0.87), respectively. Results were concordant with the primary analysis. Niraparib-treated patients were more likely to be free of progression or death at 4 years than placebo-treated patients (HRd, 38% versus 17%; overall, 24% versus 14%). The most common grade ≥ 3 treatment-emergent adverse events in niraparib patients were thrombocytopenia (39.7%), anaemia (31.6%), and neutropenia (21.3%). Myelodysplastic syndromes/acute myeloid leukaemia incidence rate (1.2%) was the same for niraparib- and placebo-treated patients. Overall survival remained immature. Conclusions: Niraparib maintained clinically significant improvements in PFS with 3.5 years of follow-up in patients with newly diagnosed advanced ovarian cancer at high risk of progression irrespective of HRD status. No new safety signals were identified.
AB - Purpose: To report updated long-term efficacy and safety from the double-blind, placebo-controlled, phase 3 PRIMA/ENGOT-OV26/GOG-3012 study (NCT02655016). Methods: Patients with newly diagnosed advanced ovarian cancer with complete or partial response (CR or PR) to first-line platinum-based chemotherapy received niraparib or placebo once daily (2:1 ratio). Stratification factors were best response to first-line chemotherapy regimen (CR/PR), receipt of neoadjuvant chemotherapy (yes/no), and homologous recombination deficiency (HRD) status (deficient [HRd]/proficient [HRp] or not determined). Updated (ad hoc) progression-free survival (PFS) data (as of November 17, 2021) by investigator assessment (INV) are reported. Results: In 733 randomised patients (niraparib, 487; placebo, 246), median PFS follow-up was 3.5 years. Median INV-PFS was 24.5 versus 11.2 months (hazard ratio, 0.52; 95% confidence interval [CI], 0.40–0.68) in the HRd population and 13.8 versus 8.2 months (hazard ratio, 0.66; 95% CI, 0.56–0.79) in the overall population for niraparib and placebo, respectively. In the HRp population, median INV-PFS was 8.4 versus 5.4 months (hazard ratio, 0.65; 95% CI, 0.49–0.87), respectively. Results were concordant with the primary analysis. Niraparib-treated patients were more likely to be free of progression or death at 4 years than placebo-treated patients (HRd, 38% versus 17%; overall, 24% versus 14%). The most common grade ≥ 3 treatment-emergent adverse events in niraparib patients were thrombocytopenia (39.7%), anaemia (31.6%), and neutropenia (21.3%). Myelodysplastic syndromes/acute myeloid leukaemia incidence rate (1.2%) was the same for niraparib- and placebo-treated patients. Overall survival remained immature. Conclusions: Niraparib maintained clinically significant improvements in PFS with 3.5 years of follow-up in patients with newly diagnosed advanced ovarian cancer at high risk of progression irrespective of HRD status. No new safety signals were identified.
KW - Advanced ovarian cancer
KW - Maintenance therapy
KW - Niraparib
KW - PARP inhibitor
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U2 - 10.1016/j.ejca.2023.04.024
DO - 10.1016/j.ejca.2023.04.024
M3 - Article
C2 - 37263896
AN - SCOPUS:85160724581
SN - 0959-8049
VL - 189
JO - European Journal of Cancer
JF - European Journal of Cancer
M1 - 112908
ER -