Found 1 Presentation For Request "1527P"
1527P - Assessing clinical benefit of olaparib maintenance treatment in subgroups of patients with germline BRCA mutation (gBRCAm) and metastatic pancreatic cancer: Phase III POLO trial
- Daniel Hochhauser (London, United Kingdom)
Abstract
Background
The phase III POLO trial showed that in patients with metastatic pancreatic cancer (mPC) and a germline BRCA mutation (g
Methods
Participants had received first-line PBC for ≥ 16 weeks and were randomized 3:2 to maintenance olaparib 300 mg bid or placebo. The primary endpoint was PFS by blinded independent central review. Subgroup analyses assessed treatment effect consistency with the primary endpoint of PFS; multivariate analyses assessed impact of baseline factors; sensitivity analyses assessed evaluation time (scan frequency) and deviation (protocol deviation) biases.
Results
All pre-specified and
PFS analysis Olaparib, N Placebo, N HR 95% CI Primary 92 62 0.53 0.35, 0.82 ECOG status at baseline 65 38 0.61 0.38, 1.01 25 23 0.46 0.23, 0.91 Dose interruption 38 10 0.61 0.28, 1.53 No dose interruption 52 51 0.57 0.35, 0.93 Previous primary malignancy 29 12 0.61 0.28, 1.49 No previous primary malignancy 63 50 0.55 0.35, 0.87 Liver metastasis 61 48 0.61 0.39, 0.97 Europe 49 39 0.59 0.35, 1.00 Adjusted for 13 baseline factors 83 56 0.54 0.36, 0.82 Evaluation time bias 92 62 0.55 0.36, 0.85 Deviation bias 71 49 0.47 0.29, 0.76
Conclusions
Maintenance olaparib provided a consistent, significant PFS benefit versus placebo in patients with mPC and a g
Clinical trial identification
NCT02184195.
Editorial acknowledgement
Oxford PharmaGenesis, Oxford, UK.
Legal entity responsible for the study
AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Funding
AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Disclosure
D. Hochhauser: Research grant/Funding (self), research collaboration: Merck Serono. H. Kindler: Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: Astellas; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: BMS; Advisory/Consultancy, Research grant/Funding (institution): Deciphera; Advisory/Consultancy: Five Prime; Advisory/Consultancy, Research grant/Funding (institution): INHIBRx; Advisory/Consultancy: Inventiva; Advisory/Consultancy: Kyowa; Advisory/Consultancy: Merck; Advisory/Consultancy: Paredox; Research grant/Funding (institution): Aduro; Research grant/Funding (institution): Blueprint; Research grant/Funding (institution): Deciphera; Research grant/Funding (institution): Fibrogen; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Merck; Honoraria (institution): Polaris; Research grant/Funding (institution): Verastem. P. Hammel: Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Erytech; Honoraria (self): BMS; Honoraria (self): Servier. M. Reni: Advisory/Consultancy: Lilly; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Celgene; Advisory/Consultancy: Shire; Advisory/Consultancy: Baxter; Advisory/Consultancy: Novocure; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Baxalta; Advisory/Consultancy: Novartis; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Servier; Travel/Accommodation/Expenses: AstraZeneca. E. Van Cutsem: Honoraria (self): Array; Honoraria (self): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Bayer; Honoraria (self): Biocartis; Honoraria (self): Bristol Myers Squibb; Honoraria (self), Research grant/Funding (institution): Celgene; Honoraria (self): Daiichi; Honoraria (self): Halozyme; Honoraria (self): GSK; Honoraria (self): Incyte; Honoraria (self), Research grant/Funding (institution): Ipsen; Honoraria (self), Research grant/Funding (institution): Lilly; Honoraria (self), Research grant/Funding (institution): Merck Sharp & Dohme; Honoraria (self), Research grant/Funding (institution): Merck KGaA; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self): Pierre-Fabre; Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self), Research grant/Funding (institution): Servier; Honoraria (self): Sirtex and Taiho; Research grant/Funding (institution): Boehringer-Ingelheim. T. Macarulla: Advisory/Consultancy, Travel/Accommodation/Expenses: Shire Pharmaceuticals; Advisory/Consultancy: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Servier; Advisory/Consultancy: Baxter; Advisory/Consultancy, Travel/Accommodation/Expenses: Celgene; Advisory/Consultancy: QED Therapeutics; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Amgen; Advisory/Consultancy, Travel/Accommodation/Expenses: Incyte and H3 Biomedicine; Travel/Accommodation/Expenses: Sanofi. M.J. Hall: Non-remunerated activity/ies: Myriad Genetic Laboratories; Travel/Accommodation/Expenses, Non-remunerated activity/ies: Caris Life Science; Non-remunerated activity/ies: Foundation Medicine; Non-remunerated activity/ies: Invitae; Non-remunerated activity/ies: Ambr; Travel/Accommodation/Expenses: AstraZeneca; Research grant/Funding (institution): Merck. J.O. Park: Honoraria (self), Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Servier; Research grant/Funding (institution): MedPacto; Honoraria (self): AstraZeneca; Honoraria (self): Sanofi ; Honoraria (self): Merck Sereno. D. Arnold: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Non-remunerated activity/ies: Bayer; Advisory/Consultancy, Non-remunerated activity/ies: BMS; Advisory/Consultancy: Biocompatibles; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy, Non-remunerated activity/ies: MSD; Advisory/Consultancy, Non-remunerated activity/ies: Servier; Advisory/Consultancy, Non-remunerated activity/ies: Sanofi; Advisory/Consultancy, Non-remunerated activity/ies: Roche; Advisory/Consultancy, Non-remunerated activity/ies: Sirtex; Advisory/Consultancy: Terumo. D-Y. Oh: Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy, Research grant/Funding (self): Novartis; Advisory/Consultancy: Genentech/Roche; Advisory/Consultancy: Merck Serono; Advisory/Consultancy: Bayer; Advisory/Consultancy: Taiho; Advisory/Consultancy: ASLAN; Advisory/Consultancy: Halozyme; Advisory/Consultancy: Zymeworks ; Advisory/Consultancy: Celgene; Research grant/Funding (self): Array; Research grant/Funding (self): Eli Lilly. A. Reinacher-Schick: Research grant/Funding (institution): Alexion; Research grant/Funding (institution), Travel/Accommodation/Expenses: Amgen; Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Celgene; Research grant/Funding (institution), Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Mologen Berlin; Research grant/Funding (institution): AIO Studien GmbH; Research grant/Funding (institution): Pharma Consulting Group AB Schweden; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Research grant/Funding (institution): Servier ; Research grant/Funding (institution): Syneed medidata GmbH; Honoraria (self), Travel/Accommodation/Expenses: Merck-Serono; Travel/Accommodation/Expenses: onkowissen.de; Travel/Accommodation/Expenses: Pierre Fabre; Honoraria (self): Amgen, AstraZeneca, Baxalta; Honoraria (self): BMS; Honoraria (self), Travel/Accommodation/Expenses: MSD; Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Travel/Accommodation/Expenses: Sanofi Aventis ,Servier; Honoraria (self): Shire. G. Tortora: Honoraria (self): Celgene; Honoraria (self): AstraZeneca; Honoraria (self): BMS; Honoraria (self): Pfizer; Honoraria (self): Merck Serono ; Honoraria (self): Servier. H. Algül: Advisory/Consultancy: Servier, ; Advisory/Consultancy: Celgene; Advisory/Consultancy: Astra Zeneca; Advisory/Consultancy: MSD,; Research grant/Funding (self): Chugai; Non-remunerated activity/ies: Lilly ; Non-remunerated activity/ies: Revolution Medicine. E.M. O'Reilly: Advisory/Consultancy: Inovio, Jazz, OncoQuest; Advisory/Consultancy, Research grant/Funding (self): AstraZeneca, Agios, Array; Research grant/Funding (self): BMS, Polaris Puma; Advisory/Consultancy: Janssen, Kyowa Kirin; Advisory/Consultancy, Research grant/Funding (self): Casi,Celgene, Beigene,; Advisory/Consultancy: LAM, Merck ; Advisory/Consultancy: Loxo, Mina; Advisory/Consultancy, Research grant/Funding (self): Exelixis, Halozyme,Incyte; Advisory/Consultancy: Novella,Onxeo, OncoQuest; Advisory/Consultancy: 3DMed, PCI Biotech; Advisory/Consultancy: AlignMed, Pfizer; Advisory/Consultancy: Amgen, Pieris; Advisory/Consultancy: Antengene, RedHill; Advisory/Consultancy: Aptus,Sanofi; Advisory/Consultancy: Aslan, Servier; Advisory/Consultancy: Astellas, Silsenseed; Advisory/Consultancy: Bioline, SillaJen; Advisory/Consultancy: Boston Scientific, Sobi; Advisory/Consultancy: BridgeBio, Targovax; Advisory/Consultancy: CARsgen, Tekmira; Advisory/Consultancy: Cipla, TwoXAR; Advisory/Consultancy: CytomX, Vicus; Advisory/Consultancy: Daiichi,Yakult and Yiviva; Advisory/Consultancy: Debiopharm, Delcarth,Hengrul,; Advisory/Consultancy: Eisai, Genoscience,Ipsen; Research grant/Funding (self): QED, Roch; Advisory/Consultancy, Research grant/Funding (self): Bayer,Lilly; Research grant/Funding (self): Genetech; Research grant/Funding (self): MabVax; Research grant/Funding (self): Novartis. D. McGuinness: Full/Part-time employment, contractor: AstraZeneca. K. Cui, G. Locker: Full/Part-time employment: AstraZeneca. K. Schlienger: Full/Part-time employment: Merk. T. Golan: Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: AbbVie; Advisory/Consultancy: Teva; Advisory/Consultancy: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Merck/MSD; Speaker Bureau/Expert testimony: Bioline; Speaker Bureau/Expert testimony: Roche.