Treatment of BRCA-mutated Ovarian Cancer After 2 or More Chemotherapies

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

BRCA-mutated cancer with ≥ 2 prior therapies

Patients Enrolled

106; median 2 prior therapies

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DoR, evaluated per RECIST

Biomarkers

BRCA1/2 MUT

Efficacy

ORR: 54% (9CR, 48PR, n=106)
DoR: 9.2 months (6.6-11.6)

Exploratory analysis Pt status:
Pt-S (n=79): ORR: 66%
Pt-R (n=20): ORR: 25%
Pt-Rf (n=7): ORR: 0%

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: anemia/decreased hemoglobin (25%)

Conclusion

Promising responses in BRCA MUT patients

Reference

Rubraca Prescribing Info, Version 04/2018
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209115s003lbl.pdf