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, DoR, PFS, evaluated per RECIST

Biomarkers

gBRCA1/2

Efficacy

ORR: 71.9% (6CR,17PR, n=32)
DCR (7 months): 65.6%
PFS: 11.1 months
DoR: 10.2 months

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: anemia (17.6%), elevated lipase (11.8%)

Conclusion

Promising activity of non-chemotherapy combination in gBRCA MUT patients

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://www.sgo.org/wp-content/uploads/2018/03/Late-Breaking-Abstracts-2018-SGO-Annual-Meeting-on-Womens-Cancer.pdf

Drew Y et al. Phase II study of olaparib + durvalumab (MEDIOLA): Updated results in germline BRCA-mutated platinum-sensitive relapsed (PSR) ovarian cancer (OC). ESMO (2019) Abstr 1190PD
https://cslide.ctimeetingtech.com/esmo2019/attendee/confcal/presentation/list?q=mediola