827P - First real-life data on olaparib in 1st line (1stL) maintenance BRCA1/2 mutated epithelial ovarian cancer (EOC) in France: Descriptive analysis of 201 patients (pts) enrolled in the cohort temporary authorization for use (ATUc)

Background

Olaparib (Ola), an oral PARP inhibitor, showed significant benefit, in terms of disease control and progression-free survival, with a manageable safety profile for BRCAm pts in the SOLO-1 study. ATUc is granted by French Health Authorities to allow the use of innovative drugs before Marketing Authorisation in a given indication.

Methods

Ola 300mg BID tablets was given as maintenance monotherapy to advanced BRCAm high-grade EOC pts who were in complete (CR) or partial (PR) response following completion of 1^stL platinum-based chemotherapy (CT). Germline (g) and somatic (s) BRCA testing was performed in routine practice, prior to ATUc inclusion. Clinical and safety data were collected on a monthly basis until the end of ATUc.

Results

From March 11^th, 2019 to January 16^th, 2020, 107 centres requested an inclusion for 238 pts; 201 requests were accepted, 28 excluded. Pts characteristics were: median age 62.5y, ovarian cancer (OC) 87.6%, FIGO stage: III 71.8%, IV 28.1%, high grade serous 93%, gBRCAm 38.4% sBRCAm 52.5%, g+sBRCAm 9.1%, surgery 83.6% (upfront surgery 31.9%, interval cytoreductive surgery 65.1%), complete resection: 90.8%, response after 1^stL CT: CR 83.8%, PR 16.2%, median time from CT end to ATUc inclusion 6.4 weeks. 194 pts received Ola, 126 pts (64.9%) experienced ≥1 adverse event (AE), 68 (35.0%) pts experienced ≥1 treatment related AE (ADR) including 24 (12.4%) pts with ≥1 serious ADR. 6 pts (3.1%) had AEs leading to Ola discontinuation: 2 anaemia, 2 asthenia, 1 dysgueusia, 1 fatigue, 1 dizziness and 1 hypersensibility. No myelodysplastic syndrome/acute myeloid leukemia was reported and no AE leading to death.

Conclusions

We present the first French real-life data through ATUc program with Ola in 1^stL BRCAm. All pts had a BRCA1/2 testing which is routinely performed in France. Olaparib was well tolerated and no new safety signals were observed in this real-life pts population. The enrolment of 201 pts in only 10 months highlights the strong unmet need for mBRCA EOC pts in 1^stL maintenance treatment.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

C. Bonnard, A. Lahrache, A. Debbache, A. Kacher-Damache, M. Delplanque, D. Suau, A-C. Richard, O. Brenner, A. Lahouegue, M. Urbieta: Full/Part-time employment: AstraZeneca. All other authors have declared no conflicts of interest.