Found 1 Presentation For Request "740P"
740P - Olaparib maintenance monotherapy for non-germline BRCA1/2-mutated (non-gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC): Exploratory biomarker analyses of the phase IIIb OPINION study
- Kristina Lindemann (Oslo, Norway)
Abstract
Background
Maintenance olaparib is a standard of care for PSR OC patients (pts), including those without a
Methods
279 pts were enrolled and received olaparib maintenance (tablets; 300 mg bid). Tumour tissue samples were analysed by Myriad MyChoice HRD Plus assay to determine homologous recombination repair gene mutation (non-BRCA HRRm; qualifying alteration detected in at least 1 of 13 prespecified HRR genes, excluding BRCAm) and
Results
12% of pts (34/279) had a non-BRCA HRRm ( CI, confidence interval; NE, not evaluable; PF, progression-free.
Subgroup Pts, n PFS events, n (%) PF at 12 mo, PF at 18 mo, 279 210 (75) 9.2 (7.6–10.9) 38.5 (32.7–44.3) 24.3 (19.2–29.7) HRRm Non HRRm 34 198 18 (53) 163 (82) 14.8 (10.8–NE) 7.6 (7.2–9.1) 60.1 (41.3–74.6) 29.7 (23.3–36.3) 43.5 (25.9–59.8) 17.5 (12.4–23.5) D ND WT 131 117 19 103 (79) 82 (70) 14 (74) 8.1 (7.2–10.3) 10.8 (8.1–13.7) 10.7 (7.2–13.6) 34.9 (26.7–43.3) 43.4 (34.1–52.3) 42.1 (20.4–62.5) 19.0 (12.5–26.6) 31.0 (22.5–39.8) 24.1 (7.8–45.1)
Conclusions
Despite limitations in subgroup size, clinical benefit with maintenance olaparib was observed in non-gBRCAm pts with PSR OC, irrespective of biomarker status. Pts with a non-BRCA HRRm achieved longer PFS benefit compared with the non HRRm subgroup.
Clinical trial identification
NCT03402841.
Editorial acknowledgement
Medical writing assistance was provided by Rachel Dodd, PhD, from Mudskipper Business Limited, funded by AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Disclosure
K. Lindemann: Financial Interests, Personal, Advisory Role, Consulting/advidory: AstraZeneca, GSK and Esai; Financial Interests, Personal, Research Grant: GSK. N. Colombo: Financial Interests, Personal, Advisory Role, Advisory/consulting: Roche, Pharmamar, AstraZeneca, MSD/Merk, Clovis Oncology, Tesaro, GSK, Novartis, Pfizer, Takeda, BIOCAD, Immunogen, Mersana, Eisai, Oncxerna. A. González-Martín: Financial Interests, Personal, Research Grant, Funding for ENGOT Ov41 trial /ANITA: ROCHE & GSK; Financial Interests, Personal, Advisory Role, Consulting: Alkermes, Amgen, AstraZeneca, Clovis, GSK, Genmab, Mersana, Roche, MSD, Inmunogen, Oncoinvent, Pharmamar, Sotio, Takeda; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Clovis, GSK, Roche, MSD; Financial Interests, Personal, Other, Travel grant: AstraZeneca, GSK, Roche, MSD, Pharmamar; Financial Interests, Personal, Leadership Role, Chairman: GEICO; Financial Interests, Personal, Leadership Role, Chairman (2018-2020): ENGOT. R. Davidson: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. C. Blakeley: Financial Interests, Personal, Full or part-time Employment, Recently retired: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. J. Bennett: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. A. Barnicle: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. A. Poveda: Financial Interests, Personal, Advisory Role, Consulting/advisory roles: AstraZeneca, Clovis Oncology, GlaxoSmithKline, Roche, Tesaro. All other authors have declared no conflicts of interest.