Three-year follow-up data of maintenance therapy with rucaparib/rucaparib in patients with ovarian cancer

Clinical Discussion Key efficacy results from 3-year follow-up data for patients with newly diagnosed advanced ovarian cancer treated in the Phase 3 ATHENA-MONO trial (NCT01968213). Results presented at the 2024 SGO Women's Cancer Annual Meeting showed that time to first subsequent treatment (TFST) and time to second progression (PFS2) data demonstrated sustained benefit for single-agent rucaparib compared with placebo.

Patients who received rucaparib plus placebo nivolumab in the intention-to-treat (ITT) population experienced a median TFST of 23.3 months (95%C I, 19.3-26.8), compared with 12.1 months (95% CI, 10.1-16.1) among patients who received double placebo (n = 111; HR, 0.52; 95% CI, 0.40-0.67). Among patients with homologous recombination deficiency (HRD), the median TFST was 32.7 months (95% CI, 26.0 – not reached [NR]) in the rucaparib group (n = 185) compared with the double placebo group (n = 49 HR, 0.50; 95% CI, 0.33-31.7).

In addition, the median PFS2 for ITT patients who received rucapanib was 36.0 months (95% CI, 29.5-44.6), compared with 26.8 months (95% CI, 21.7-NR) for patients who received placebo. In the HRD-positive population, the median PFS2 were NR (95% CI, 39.0-NR) and 39.9 months (95% CI, 24.2-NR).

Based on these data, the clinical benefit of rucaparib persists beyond ovarian cancer progression and the end of two years of treatment. Although overall survival (OS) data are still immature, a significant trend in favor of rucaparib was observed. At the time of data cutoff, the OS data maturity of the ITT population was 35%, and the maturity of the HRD population was 25%. These TFST and PFS2 findings expand the understanding of the therapeutic benefits of rucaparib, positioning it as a viable option for maintenance therapy after first-line therapy in patients with advanced ovarian cancer. The sustained efficacy of rucapanib in prolonging the progression-free interval suggests its utility in delaying disease progression and may improve long-term outcomes in this patient population.

These findings have important clinical implications and suggest that rucaparib may provide a survival benefit when used as first-line treatment for patients with ovarian cancer. Further follow-up and analysis are needed to validate these preliminary findings and elucidate the full efficacy and safety of rucaparib in this patient population.