A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors

Trial ID # NCT02734004
Phase I/II
Drug Class DNA Damage Repair Pathway Inhibitors:PARP
Drug Name Olaparib
Alternate Drug Names AZD2281, Lynparza
Drugs in Trial Durvalumab, Olaparib
Eligible Participant

Advanced solid tumors

Patients Enrolled

288 [32 ovarian gBRCA MUT; median 2 prior therapies (1-6)]

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, evaluated per RECIST

Biomarkers

gBRCA1/2

Efficacy

ORR: 72% (6CR,17PR, n=32)
DCR (3 months): 81% (6CR, 17PR, 3SD, n=32)

Exploratory analysis # of prior therapies:
1 prior therapy (n=13): ORR: 77%
2 prior therapies (n=9): ORR: 67%
3+ prior therapies (n=10): ORR: 70%

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: hypothyroidism (15%), anemia (12%), rash (12%)

Conclusion

Promising activity of non-chemotherapy combination in gBRCA MUT

Reference

Drew Y et al. An open-label, phase II basket study of olaparib and durvalumab (MEDIOLA): Results in germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed (PSR) ovarian cancer (OC). SGO (2018) late breaking abstract 4
https://sgo.confex.com/sgo/2018/meetingapp.cgi/Paper/11349