KEY TAKEAWAYS
- The ATHENA-MONO phase 3 trial aimed to investigate the sustained PFS benefit of RUC in pts with advanced OC following 1L treatment.
- Researchers observed sustained PFS improvement with RUC, regardless of risk, with no new safety issues.
RUC provided a sustained PFS benefit in pts with newly diagnosed advanced ovarian cancer (OC) after first-line (1L) treatment.
Rebecca Kristeleit and the team aimed to assess the long-term efficacy and safety of rucaparib (RUC) in this patient population.
They performed an inclusive analysis of patients (pts) with high-grade, FIGO stage III-IV OC who responded to 1L treatment. They were randomized 4:1 to receive either 600 mg BID RUC (N = 427) or placebo (N = 111) for up to 2 years. The study conducted an exploratory analysis to evaluate updated investigator-assessed progression-free survival (PFS) (INV), encompassing primary populations (homologous recombination deficiency [HRD] and intent to treat [ITT]), non-nested HRD subgroups, and stratifications based on FIGO stage, surgical outcomes, and timing of surgery. For pts in complete response (CR) at baseline, recurrence-free survival (RFS) was defined as the time from randomization to disease recurrence (new lesions on imaging) or death.
After a median follow-up of 4.0 and 3.5 years, with additional 1.9 and 1.6 years respectively, median PFS was consistently longer or not reached (NR) in pts treated with RUC compared to placebo in both the ITT populations and across HRD and non-nested HRD subgroups. In the higher-risk subgroup, 27.7% of RUC-treated pts versus 8.6% of placebo-treated pts remained progression-free at 4 years. In the lower-risk subgroup, 41.9% versus 37.2% of pts, respectively, were progression-free at this time point.
Among pts in CR at baseline, RUC reduced the risk of disease recurrence or death by 51%. The safety profile of RUC remained consistent with the primary analysis. Three new cases of myelodysplastic syndrome or acute myeloid leukemia were reported post-primary analysis, with incidence rates similar in both RUC and placebo arms (<1%).
The study concluded that RUC demonstrated sustained, clinically significant improvement in PFS over 4.0 years of follow-up in pts with newly diagnosed advanced OC, irrespective of risk stratification. Additionally, no new safety signals were identified.
THe study was sponsored by the pharmaand GmbH.
Source: https://cslide.ctimeetingtech.com/gynae24hybrid/attendee/confcal/show/session/4
Clinical Trial: https://clinicaltrials.gov/study/NCT03522246
Kristeleit R, O’Malley D, Lim M.C., et al. (2024). “Updated progression-free survival (PFS) in patients (pts) with newly diagnosed advanced ovarian cancer (OC) treated with rucaparib (RUC) in ATHENA-MONO.” Presented at ESMO-GU 2024 (Abstract 49MO).
