| Trial ID # | NCT02855944; ARIEL4 |
| Phase | III |
| Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
| Drug Name | Rucaparib |
| Alternate Drug Names | AG-014699, PF 01367338, CO-338, Rubraca |
| Drugs in Trial | Carboplatin, Cisplatin, Paclitaxel, Rucaparib, Gemcitabine |
| Eligible Participant | Recurrent BRCA MUT ovarian cancer |
| Patients Enrolled | 349; median 2 prior therapies; 21% Pt-S. 28% Part-Pt-S, 51% Pt-R; 6.6% w/ BRCA reversion mutation |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Randomized |
| Endpoints | ORR, DoR, PFS, OS, evaluated per RECIST |
| Biomarkers | BRCA status |
| Efficacy | Ruc (n=205) vs Treatment of Physician's Choice (TPC) (n=105) (Monotherapy platinum (cisplatin or carboplatin) or platinum-based doublet chemotherapy (carboplatin/paclitaxel, carboplatin/gemcitabine, or cisplatin/gemcitabine or single agent paclitaxel): ORR: 40.3 vs 32.3%, p=0.13 Exploratory analysis: w/ BRCA reversion mutation, Pt-status |
| Clinically Significant Adverse Events | Ruc vs TPC: |
| Conclusion | Recurrent BRCA MUT patients, including those who are platinum sensitive or platinum resistant, receive benefit with rucaparib treatment when compared to chemotherapy; the presence of a BRCA reversion mutation predicts for primary resistance to rucaparib |
| Reference | Kristeleit R et al. Rucaparib versus standard-of-care chemotherapy in patients with relapsed ovarian cancer and a deleterious BRCA1 or BRCA2 mutation (ARIEL4): an international, open-label, randomised, phase 3 trial. Lancet Oncol (2022) 23(4):465-478 |