A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)

Trial ID # NCT01891344; ARIEL2
Phase II
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Rucaparib
Alternate Drug Names Rubraca, CO-338, PF 01367338, AG-014699
Drugs in Trial Rucaparib
Eligible Participant

Platinum sensitive ovarian cancer at first recurrence (ARIEL2, Part 1)

Patients Enrolled

204

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, PFS, evaluated per RECIST

Biomarkers

Exploratory: BRCA1/2; LOH (by FoundationFocus CDx BRCA LOH)

Efficacy

Data from ARIEL2, Part 1:
BRCA MUT (n=40) vs BRCA WT LOH high (n=82) vs BRCA WT LOH low (n=70):

ORR: 80 vs 29 vs 10%
PFS: 12.8 vs 5.7 vs 5.2 months, HR: 0.27 (0.16-0.44, p<0.0001); HR: 0.62 (0.42-0.90, p=0.011)

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: anemia or decreased hemoglobin (22%), elevated liver enzymes (13%)

Conclusion

Improved ORR and PFS with rucaparib treatment in BRCA MUT patients

Reference

Swisher EM et al. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol (2017) 18(1):75-87
https://www.ncbi.nlm.nih.gov/pubmed/27908594

Swisher EM et al. Characterization of patients (pts) with long-term responses to rucaparib in recurrent ovarian cancer (OC). J Clin Oncol (2020) 38: (suppl; abstr 6015)
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.6015

Swisher EM et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2020/07/Rucaparib-long-term-responders-ARIEL-2-ASCO-2020.pdf

Swisher EM et al. Molecular and clinical determinants of response and resistance to rucaparib for recurrent ovarian cancer treatment in ARIEL2 (Parts 1 and 2). Nat Commun (2021) 12(1):2487
https://pubmed.ncbi.nlm.nih.gov/33941784/

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