Investigator

Vit Drochytek

Fakultní nemocnice Královské Vinohrady, Department of Gynaecology and Obstetrics

VDVit Drochytek
Papers(2)
Fertility sparing tre…Rucaparib maintenance…
Collaborators(9)
Bradley J. MonkC. ConnorD. DespainHung-Hsueh ChouLainie MartinM. BeinerOladapo O. YekuR. AgarwalRebecca Kristeleit
Institutions(9)
Charles UniversityFlorida Cancer Specia…Top Institute PharmaLinkou Chang Gung Mem…University of Pennsyl…Tel Aviv UniversityHarvard UniversityNorthampton General H…King's College London

Papers

Rucaparib maintenance for newly diagnosed advanced ovarian cancer: interim overall survival, progression-free survival, and safety at 5 years of follow-up from the phase III ATHENA-MONO/GOG-3020/ENGOT-ov45 study

We report the long-term efficacy and safety from the multicenter, randomized, double-blind, placebo-controlled, phase III ATHENA-MONO/GOG-3020/ENGOT-ov45 (NCT03522246) study of first-line rucaparib maintenance for advanced ovarian cancer. Patients were randomized 4 : 1 to oral rucaparib + intravenous (i.v.) placebo or oral + i.v. placebo. Stratification factors were homologous recombination deficiency (HRD; BRCA mutation and loss of heterozygosity status) classification, residual disease post-chemotherapy, and surgical timing. The primary endpoint was investigator-assessed progression-free survival (invPFS) in HRD and intent-to-treat (ITT) populations. Overall survival (OS) and safety were secondary endpoints. Second event of progression (PFS2) and time to first subsequent treatment (TFST) were exploratory. Interim OS and final safety analyses data cut-off was 9 March 2023. Updated invPFS, PFS2, and TFST analyses data cut-off was 5 May 2025. Median invPFS follow-up was ∼59 months for both rucaparib (HRD, n = 185; ITT, n = 427) and placebo (HRD, n = 49; ITT, n = 111). invPFS was significantly longer with rucaparib versus placebo in the HRD [31.4 versus 12.0 months; hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.35-0.76] and ITT (20.2 versus 9.2 months; HR 0.53, 95% CI 0.42-0.69) populations. Interim OS was immature (OS maturity: ITT 35%) with the median (95% CI) OS not reached with rucaparib and 46.2 (34.6-not reached) months with placebo for the ITT population (HR 0.83, 95% CI 0.58-1.17). ITT TFST (median 23.6 versus 12.1 months) and PFS2 (35.1 versus 26.9 months) were longer with rucaparib versus placebo. Overall, 34.6% of patients receiving rucaparib completed the 24-month treatment cap versus 17.3% receiving placebo. As of 5 May 2025, 40.0% of patients on rucaparib were still on study and in long-term follow-up. Safety remained consistent with the primary analysis. Rucaparib monotherapy provides significant and durable long-term benefit as first-line maintenance for patients with advanced ovarian cancer with and without HRD.

2Papers
9Collaborators
1Trials
AppendicitisCarcinoma, Ovarian EpithelialOvarian Neoplasms

Positions

2016–

Researcher

Fakultní nemocnice Královské Vinohrady · Department of Gynaecology and Obstetrics

2016–

Researcher

Charles University, Third Faculty of Medicine · Department of Gynaecology and Obstetrics

Education

2017

Charles University, Faculty of Medicine in Pilsen · Department of Gynaecology and Obstetrics

Country

CZ

Links & IDs
0000-0002-3391-1412

Researcher Id: F-6090-2018