781P - Olaparib maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer (PSROC) and a BRCA mutation (C-PATROL): Overall survival (OS) in predefined subgroups

Background

In patients with PSROC who were in response to platinum-based chemotherapy (PBC), maintenance monotherapy with PARP-inhibitor (PARPi), olaparib has previously shown good effectiveness and tolerability within the C-PATROL study. Main outcome data were initially presented at ESMO Congress 2023 (Poster No.: 802P). Here we present the OS in subgroups of interest.

Methods

The prospective German non-interventional study C-PATROL (NCT02503436) captured routine clinical data of olaparib maintenance after response to current PBC according to label in patients with BRCA-mutated PSROC. The primary endpoint was PFS, relevant secondary endpoints included OS and safety. Only descriptive statistics were used for analyses.

Results

277 patients were enrolled between 10/2015 and 10/2019 of whom 267 patients were included in ITT set (study selection criteria fulfilled). Median duration of olaparib treatment was 13.6 months (0.1–80.9) and median follow-up was 23.5 months (range 0.0–80.5). Patient`s characteristics were median age: 60 yrs; ECOG ≤1: 93%; ≥2 relapses: 32%; ≥3 prior PBC: 29%. Median OS in ITT was 35.4 months (95% CI 29.2–49.9). The longest median OS was observed in patients with a complete response (CR) to the current PBC (median; 95% CI not reached [nr]) vs partial response (27.7; 24.44–33.68), a complete debulking after the surgery (DBS) at current relapse (median: nr; 95% CI 60.76–nr) vs non-MTF/no surgery (27.37; 24.44–33.55) and a BRCA2 mutation (median: 72.34; 95% CI 53.42–nr) vs BRCA1 mutation (30; 26.48–36.22). OS data related to age, treatment line, comorbidities at baseline, comedication at baseline and during study, capsule or tablet as 1^st dose of olaparib, treatment-free interval after penultimate PBC will be presented at the congress. Adverse events (AEs) were consistent with the known tolerability profile of olaparib.

Conclusions

Olaparib is effective and safe in the BRCA-mutated PSROC real-world setting and reflects the data observed within clinical trials. In this study some expected predefined subgroup-characteristics (like CR to PBC, no residual tumor after DBS, earlier line of therapy, lack of comorbidities) showed beneficial OS prognosis.

Clinical trial identification

NCT02503436.

Editorial acknowledgement

Medical writing assistance provided by Dr. Yvonne Holighaus, Alcedis GmbH, Giessen, also funded by AstraZeneca.

Legal entity responsible for the study

This study is funded by AstraZeneca and is part of an alliance between AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

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, Stemline Menarini; 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: MSD, ImmunoGen; Financial Interests, Personal, Invited Speaker: MSD, GSK, AstraZeneca, Novartis. M.K. Welslau: Financial Interests, Advisory Board: Amgen, Bristol Myers Squibb, Celgene, Gilead, Hexal, Janssen, Lilly, Medac, Novartis, Roche, Sanofi; Financial Interests, Other, Honoraria: Amgen, Astellas, AstraZeneca, Celgene, Gilead, Hexal, Janssen, Novartis, Roche, Sanofi. J.P. Grabowski: Financial Interests, Advisory Board: AstraZeneca, GSK, MSD, Eisai, Esteve; Financial Interests, Research Grant: AstraZeneca, GSK, MSD, Esteve; Financial Interests, Speaker’s Bureau: AstraZeneca, GSK, MSD, Esteve, Eisei; Financial Interests, Other, Honoraria: AstraZeneca, GSK, MSD, Eisai; Financial Interests, Other, Travel Expenses: AstraZeneca, GSK, Eisai, Esteve; Financial Interests, Other, Travel expenses: MSD. A. Schneeweiss: Financial Interests, Research Grant: Celgene, Roche, AbbVie; Financial Interests, Other, Travel expenses: Celgene, Roche, Pfizer; Financial Interests, Other, Honoraria: Roche, Celgene, Pfizer, AstraZeneca, Novartis, MSD, Tesaro, Lilly, Lilly, Seagen, Gilead, GSK, Bayer, Amgen, Pierre Fabre; Financial Interests, Other, Travel Expenses: AstraZeneca. A.D. Hartkopf: Financial Interests, Advisory Board: Roche, Novartis, MSD, AstraZeneca, GSK, ExactScience, Riemser, Teva, Onkowissen, Gilead, Menarini Stemline, Pfizer; Financial Interests, Other, Honoraria: Roche, Novartis, Lilly, MSD, AstraZeneca, Seagen, GSK, ExactScience, Riemser, Teva, Onkowissen, Gilead, Menarini Stemline; Financial Interests, Speaker’s Bureau: Roche, Novartis, Lilly, AstraZeneca, MSD, Daichii Sankyo, Seagen, GSK, ExactScience, Gilead, Menarini Stemline, Pfizer, Eisai; Financial Interests, Other, Travel expenses: Roche, Novartis, Lilly, AstraZeneca, GSK, ExactScience, Gilead, Menarini Stemline, Pfizer, Daichii Sankyo. S. Becker: Financial Interests, Invited Speaker: Roche, Novartis, AstraZeneca, MSD, Pfizer. D. Bauerschlag: Financial Interests, Advisory Board: AstraZeneca, Eisai, MSD, Roche, Novartis; Financial Interests, Speaker’s Bureau: AstraZeneca; Financial Interests, Other, Honoraria: AstraZeneca, Eisai, MSD, Roche, Novartis; Financial Interests, Other, travel, accommodations, expenses: AstraZeneca, Eisai, MSD, Roche, Novartis. P.A. Fasching: Financial Interests, Personal, Advisory Board: Roche, Novartis, Pfizer, Daiichi Sankyo, Eisai, Merck, Sharp & Dohme, AstraZeneca, Hexal, Lilly, Pierre Fabre, Seagen, Agendia, Sanofi Aventis, Medac, Menarini, Veracyte; Financial Interests, Personal, Invited Speaker: Novartis, Daiichi Sankyo, Eisai, Merck, Sharp & Dohme, AstraZeneca, Lilly, Seagen, Gilead, Mylan; 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.M. Glowik: Financial Interests, Full or part-time Employment: AstraZeneca. J. Sehouli: Financial Interests, Personal, Advisory Board: Roche, GSK, AstraZeneca, MSD, Tesaro, ImmunoGen, Tubulis, Novocure, Incyte; Financial Interests, Personal, Invited Speaker: Eisei; Financial Interests, Institutional, Funding: Roche, GSK, AstraZeneca; Financial Interests, Institutional, Coordinating PI: Novocure; Non-Financial Interests, Institutional, Proprietary Information: ENGOT/NOGGO; Non-Financial Interests, Leadership Role, Council Member: ESGO; Non-Financial Interests, Leadership Role: North-Eastern German Society of Gynecological Oncology (NOGGO), Arbeitsgemeinschaft für Gynäkologische Onkologie (AGO), Pab-Arabian Research Society of Gynecological Oncology (PARSGO). All other authors have declared no conflicts of interest.