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

Advanced solid tumors

Patients Enrolled

288 [32 ovarian Pt-S gBRCA MUT, median 2 prior therapies (1-6); 63 ovarian Pt-S non-gBRCA MUT, median 1 prior (1-2)]

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

CBR, ORR, DCR, DoR, PFS, evaluated per RECIST

Biomarkers

gBRCA1/2

Efficacy

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

Ola+Dur, non-gBRCA MUT (n=32)
ORR: 34%
CBR: 28%
DoR: 6.5 months
PFS: 5.5 months

Ola+Dur+Bev, non-gBRCA MUT (n=31)
ORR: 87%
CBR: 77%
DoR: 11 months
PFS: 14.7 months

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 platinum-sensitive patients

Reference

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

Drew Y et al. Phase II study of olaparib (O) plus durvalumab (D) and bevacizumab (B) (MEDIOLA): Initial results in patients (pts) with non-germline BRCA-mutated (non-gBRCAm) platinum sensitive relapsed (PSR) ovarian cancer (OC). Annals Oncol (2020) 31 (suppl_4): abstract 814MO
https://www.clearityfoundation.org/wp-content/uploads/2020/10/MEDIOLA-ESMO-2020.pdf

MEDIOLA Examines Triplet Therapy in Ovarian Cancer — New cohort adds bevacizumab to olaparib /durvalumab combo, MedPage today 10/7/2020 
https://www.medpagetoday.com/meetingcoverage/esmovideopearls/88997?xid=nl_mpt_DHE_2020-10-08&eun=g1150291d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202020-10-08&utm_term=NL_Daily_DHE_dual-gmail-definition