Dr Kristeleit on 3-Year Follow-up Data for Rucaparib Maintenance in Ovarian Cancer

Rebecca Kristeleit, BSc, MBChB, MRCP, PhD, consultant medical oncologist and clinical senior lecturer, University College-London Cancer Institute, discusses key efficacy outcomes derived from 3-year follow-up data from newly diagnosed patients with advanced ovarian cancer treated in the phase 3 ATHENA-MONO trial (NCT01968213).

Findings presented at the 2024 SGO Annual Meeting on Women’s Cancer demonstrated that time to first subsequent therapy (TFST) and time to second progression (PFS2) data pointed to a continued benefit for single-agent rucaparib (Rubraca) compared with placebo.

Patients in the intent-to-treat (ITT) population treated with rucaparib plus a placebo for nivolumab (Opdivo; n = 427) experienced a median TFST of 23.3 months (95% CI, 19.3-26.8) compared with 12.1 months (95% CI, 10.1-16.1) for those given dual placebos (n = 111; HR, 0.52; 95% CI, 0.40-0.67). In patients with homologous recombination deficiency (HRD), the median TFST was 32.7 months (95% CI, 26.0–not reached [NR]) for the rucaparib arm (n = 185) vs 15.1 months (95% CI, 10.3-31.7) for the dual placebo arm (n = 49; HR, 0.50; 95% CI, 0.33-31.7).

Additionally, patients in the ITT population given rucaparib achieved a median PFS2 of 36.0 months (95% CI, 29.5-44.6) compared with 26.8 months (95% CI, 21.7-NR) for those given placebo. In the HRD-positive population, the median PFS2 was NR (95% CI, 39.0-NR) and 39.9 months (95% CI, 24.2-NR), respectively.

Based on these data, the clinical advantages of rucaparib persist beyond progression of ovarian cancer and completion of the two-year treatment course, Kristeleit says. Furthermore, Kristeleit explains that although overall survival (OS) data remain premature, a noteworthy trend favoring rucaparib has been observed. At data cutoff, OS data were at 35% maturity for the ITT population and 25% maturity for the HRD population.

These TFST and PFS2 findings extend the understanding of rucaparib's therapeutic benefits, positioning it as a viable option for maintenance therapy following first-line treatment in patients with advanced ovarian cancer, Kristeleit continues. The sustained efficacy of rucaparib in prolonging progression-free intervals suggests its utility in delaying disease progression and potentially improving long-term outcomes in this patient population, she adds.

These findings have significant clinical implications, suggesting that rucaparib may confer a survival benefit when used as first-line therapy in patients with ovarian cancer, Kristeleit adds. Further follow-up and analysis are warranted to validate these preliminary findings and elucidate the full extent of rucaparib's efficacy and safety profile in this patient population, she concludes.