ATHENA (A Multicenter, Randomized, Double-Blind, Placebo- Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

Newly diagnosed stage III/IV ovarian cancer that responded to first-line platinum therapy

863

Maintenance

Double Blind, Randomized

PFS, OS, evaluated per RECIST

HRD status - FoundationOne CDx (BRCA MUT; BRCA WT/LOH high [LOH≥16%]; BRCA WT/LOH low [LOH<16%], BRCA WT/LOH indeterminate)

Ruc+Niv maint (n=436) vs Ruc+Placebo maint (n=427):

All patients (ITT):
PFS: 15.0 vs 20.2 months, HR: 1.29 (1.08-1.53)
OS: 49.4 vs 58.0 months, HR: 1.13 (0.93-1.38)

Exploratory analyses:
BRCA MUT: PFS: 28.9 vs 31.4 months, HR: 1.1 (0.9-1.5)
BRCA WT/LOH high: PFS: 17.3 vs 22.3 months, HR: 1.1 (0.7-1.5)
BRCA WT/LOH low: PFS: 11.0 vs 12.1 months, HR: 1.3 (1.0-1.7)
PD-L1≥5%: PFS: 22.8 vs 52.2 months, HR: 1.5 (0.9-2.4)
PD-L1≥1%: PFS: 18.3 vs 25.8 months, HR: 1.3 (1.0-1.7)

Ruc+Niv vs Ruc+Placebo:
Serious AE: AML, MDS (1.0 vs 0.9%)
Grade 3-4 AE: overall (74.6 vs 63.8%)

Nivolumab in combination with rucaparib does not add to the PFS benefit of rucaparib observed in ATHENA-MONO

Monk BJ et al. ATHENA-COMBO, a phase III, randomized trial comparing rucaparib (RUCA) + nivolumab (NIVO) combination therapy vs RUCA monotherapy as maintenance treatment in patients (pts) with newly diagnosed ovarian cancer (OC). Ann Oncol (2024) 35 (2) abstract LBA30
https://www.clearityfoundation.org/wp-content/uploads/2024/11/ATHENA-COMBO-abstract.pdf