A Phase II, Open Label, Non Randomised, Non Comparative, Multicentre Study to Assess the Efficacy and Safety of Olaparib Given Orally Twice Daily in Patients With Advanced Cancers Who Have a Confirmed Genetic BRCA 1 and/or BRCA2 Mutation (Study 42)

Trial ID # NCT01078662; Study 42
Phase II
Drug Class DNA Damage Repair Pathway Inhibitors:PARP
Drug Name Olaparib
Alternate Drug Names AZD2281, Lynparza
Drugs in Trial Olaparib
Eligible Participant

Advanced gBRCA-mutated cancer with ≥ 3 prior therapies

Patients Enrolled

299; median 5 prior therapies (1-14)

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DoR, PFS, evaluated per RECIST

Biomarkers

gBRCA1/2 MUT

Efficacy

ORR: 34% (2CR, 44PR, n=137)
DoR: 7.9 months (5.6-9.6)

Exploratory analysis Pt status:
Pt-S: ORR: 46% (n=39); DoR: 8.2 months (5.6-13.5, n=18); PFS: 9.4 months (6.7-11.4)
Pt-R: ORR: 30% (n=81); DoR: 8.0 months (4.8-14.8, n=24); PFS: 5.5 months (4.2-6.7)
Pt-Rf: ORR: 14% (n=14); DoR: 6.4 months (5.4-7.4, n=2)

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: any (30%), anemia (19%)

Conclusion

Promising responses in heavily pretreated gBRCA MUT patients

Reference

Domchek et al. Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol (2016) 140: 199-203
https://www.ncbi.nlm.nih.gov/pubmed/26723501