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 Pt-R 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