802P - Real-world data of olaparib maintenance therapy in patients with BRCA-mutated platinum-sensitive relapsed ovarian cancer: Final results of the C-PATROL study

Background

Maintenance treatment with olaparib has demonstrated significant improvements in median progression-free survival (PFS) compared with placebo in patients with platinum-sensitive relapsed ovarian cancer (PSROC) who are in response to platinum-based chemotherapy (PBC). Olaparib was the first-in-class poly (ADP-ribose) polymerase inhibitor (PARPi) approved as monotherapy in the EU in 12/2014 (hard capsules, HC, 400 mg twice daily) in BRCA-mutated (BRCAm) PSROC. In addition, film-coated tablets (FT, 300 mg, twice daily) were approved in 05/2018 in PSROC regardless of BRCA status. After entering routine clinical practice, real-world data on olaparib were limited and this non-interventional study (NIS) was initiated. Here, final survival results are reported.

Methods

The prospective NIS C-PATROL (NCT02503436) was performed at 68 sites (50 hospitals, 18 office-based) in Germany. Routine clinical data were collected of BRCAm PSROC patients treated with olaparib according to label.

Results

Between 28 Oct 2015 and 30 Sep 2019, 282 patients were enrolled. Of these, 269 patients were included in the analysis (median age: 60 yrs; ECOG ≤1: 93%; ≥2 relapses: 32%; ≥3 prior PBC: 34%). 46 patients started with FT and 223 patients with HC; 70 patients switched from HC to FT. Median follow-up was 23.5 months (range 0.00 – 80.5) and median olaparib treatment duration was 13.6 months (0.1–80.9). 10% of patients received olaparib for ≥5 years. Median PFS was 14.3 months (95% CI 12.2–18.0). Median overall survival was 35.4 months (95% CI 29.2–47.1). 132 patients received at least one subsequent medication. Adverse events (AEs) were consistent with known tolerability profile of olaparib. 31 patients (11.3%, safety set: total n=274) discontinued olaparib treatment and 60 patients (21.9%) received reduced olaparib dose due to AEs.

Conclusions

This real-word study supports efficacy and tolerability of olaparib maintenance therapy after PBC in patients with BRCAm PSROC. Long-term exposure to olaparib was observed with no new safety signals.

Clinical trial identification

NCT02503436.

Editorial acknowledgement

Medical writing assistance was provided by Dr. Yvonne Holighaus and Dr. Katharina Bakhaus, Alcedis GmbH, Giessen, funded by AstraZeneca.

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

F. Marmé: Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK/Tesaro, Clovis, Pfizer, Lilly; Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Novartis, Roche, Gilead/immunomedics, EISAI, PharmaMar, GenomicHealth, Myriad, Seagen; Financial Interests, Institutional, Invited Speaker: Seagen, Daiichi Sankyo, GSK, AstraZeneca; Financial Interests, Institutional, Advisory Board: Roche, Immunicom; Financial Interests, Institutional, Local PI: Roche, Novartis, Eisai, MSD, Vaccibody, GSK; Financial Interests, Institutional, Coordinating PI: AstraZeneca, Roche, Gilead/Immunomedics, German Breast Group, AGO Research GmbH; Financial Interests, Institutional, Funding: AstraZeneca, Lilly, Seagen. F. Hilpert: Financial Interests, Personal, Advisory Board: AstraZeneca, Roche, MSD, PharmaMar; Financial Interests, Personal, Other, Honoraria: AstraZeneca, Roche, MSD, PharmaMar, Pfizer, Novartis. M. Welslau: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Bristol Myers Squibb, Celgene, GILEAD, HEXAL, AMGEN, Janssen, Lilly, Novartis, Roche, Astellas, Sanofi. J.P. Grabowski: Financial Interests, Institutional, Speaker, Consultant, Advisor: AstraZeneca, Tesaro/GSK, Clovis, Roche, Amgen, MSD, Pfizer, Riemser, Eisai. A. Schneeweiss: Financial Interests, Institutional, Research Grant: Celgene, Roche, AbbVie; Financial Interests, Personal, Other, Travel expenses: Celgene, Roche; Financial Interests, Personal, Other, Honoraria: Celgene, Pfizer, AstraZeneca, Novartis, MSD, Tesaro, Lilly, Seagen, Gilead, GSK, Bayer, Amgen, Pierre Fabre, Roche; Financial Interests, Personal, Other, Travel Expenses: AstraZeneca, Pfizer. A.D. Hartkopf: Financial Interests, Personal, Other, Honoraria: AstraZeneca, GSK, MSD, Clovis, Miltenyi, Roche. I. Runnebaum: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, GSK, PharmaMar, Clovis, Roche, Tesaro; Financial Interests, Personal, Advisory Board: AstraZeneca, GSK, PharmaMar, Fa. Martin, Tuttlingen, Fa. Caresyntax, Clovis, Tesaro, Roche; Financial Interests, Institutional, Coordinating PI: PharmaMar. P. Fasching: Financial Interests, Personal, Advisory Board: Roche, Novartis, Pfizer, Daiichi Sankyo, Eisai, Merck, Sharp & Dohme, AstraZeneca, Hexal, Lilly, Pierre Fabre, Seagen, Agendia, Sanofi Aventis; Financial Interests, Personal, Invited Speaker: Novartis, Daiichi Sankyo, Eisai, Merck, Sharp & Dohme, AstraZeneca, Lilly, Seagen, Gilead; Financial Interests, Personal, Other, Medical Writing Support: Roche; Financial Interests, Institutional, Local PI: BionTech, Cepheid; Non-Financial Interests, Member: ASCO, Arbeitsgemeinschaft für Gynäkologische Onkologie e.V., Translational Research in Oncology, Deutsche Gesellschaft für Senologie e.v. R. Glowik: Other, Personal, Sponsor/Funding, employee of AstraZeneca: AstraZeneca. J. Sehouli: Financial Interests, Institutional, Research Grant: GSK, Clovis, AstraZeneca, Roche, Bayer; Financial Interests, Personal, Speaker, Consultant, Advisor: MSD, AstraZeneca, Clovis, Roche, GSK, Tesaro, Novocure, PharmaMar, Eisai, Bayer, Merck. All other authors have declared no conflicts of interest.