Phase III PAOLA-1/ENGOT-ov25 trial: Olaparib plus bevacizumab (bev) as maintenance therapy in patients (pts) with newly diagnosed, advanced ovarian cancer (OC) treated with platinum-based chemotherapy (PCh) plus bev

Background PAOLA-1/ENGOT-ov25 (NCT02477644) is the first Phase III trial to evaluate the efficacy and safety of a PARP inhibitor with bev as first-line (1L) maintenance therapy for advanced OC, regardless of BRCA1/2 mutation (BRCAm) status.

Methods PAOLA-1 is a randomized, double-blind, international Phase III trial. Eligible pts had newly diagnosed, FIGO stage III-IV, high-grade serous or endometrioid OC, fallopian tube or primary peritoneal cancer. Pts had received standard PCh plus bev and were in clinical complete or partial response. Pts were randomized (2:1) to olaparib tablets (300 mg bid for up to 24 months [m]) plus bev (15 mg/kg, d1, q3w, for 15 m including when combined with PCh) or placebo (pbo) plus bev, stratified by 1L treatment outcome and tumour BRCAm status. The primary endpoint was investigator-assessed progression-free survival in the intent-to-treat population (PFS; modified RECIST v1.1).

Results The primary endpoint in the intent-to-treat population showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS). The safety and tolerability profiles observed in PAOLA-1 were generally consistent with those known for each medicine.

Summary In patients with advanced primary ovarian cancer, maintenance Olaparib resulted in a statistically significant PFS improvement. This is the first time this was demonstrated regardless of BRCA mutation status.

Interessenkonflikt

Andreas Schnelzer: Vortragshonorare, Advisory Board, Travel support: Roche, AstraZeneca, Teva, Tesaro, Gedeon-Richter, Clovis, Tesaro Pharma, Philipp Harter: Honoraria: AstraZeneca, Roche, Sotio, Tesaro, Stryker, ASCO, Zai Lab, MSD; Advisory Board: AstraZeneca, Roche, Tesaro, Lilly, Clovis, Immunogen, MSD/Merck; Research Funding (Inst): AstraZeneca, Roche, Tesaro, Genmab, DFG, European Union, DKH, Genmab, Ulrich Canzler: Advisory Board: Roche, AstraZeneca; Vortragshonorare: Roche, AstraZeneca, Lilly, Nikolaus de Gregorio: Advisory/Consultancy: Roche, AstraZeneca, Tesaro, Clovis, MSD, PharmMar, Frederic Marmé: Honoraria: Roche/Genentech, Novartis, Pfizer, AstraZeneca, Tesaro, Clovis, Eisai, Celgene, Genomic Health, PharmaMar, Amgen, CureVac, MSD, Janssen-Cilag, Immunomedics; Consulting or Advisory Role: Tesaro, Pfizerm Novartis, Genomic Health, CureVac, Amgen, Celgene, Eisai, Jannsen, AstraZeneca, Roche, Vaccibody, Immunomedics; Research Funding: Roche/Genentech, Novartis, AstraZeneca, Eisai, Tesaro, Clovis, MSD, Vaccibody; Travel, Accommodations, Expenses: Roche, Pfizer, Novartis, PharmaMar, AstraZeneca, Martina Gropp-Meier: Vortragshonorar AstraZeneca, Barbara Schmalfeldt: Forschungsunterstützung: Roche, AstraZeneca, Tesaro, Pfizer; Vortragstätigkeit: Roche, AstraZeneca, Tesaro, Ethicon, PharmMar; Beratertätigkeit: Roche, AstraZeneca, Tesaro, Clovis, Novartis, Ethicon, Peter Hillemanns: Vortragshonorar AstraZeneca, Dominik Denschlag: Vortragshonorare bzw. Advisory Boards: Roche und AstraZeneca, Isabelle Ray-Coquard: Consulting fees and travel support from Roche and AstraZeneca, consulting fees from PharmaMar, Genmab, Pfizer, Tesaro, Clovis, and grant support and consulting fees from MSD. Alle anderen Autoren haben erklärt, dass kein Interessenkonflikt besteht.

Publication History

Article published online:
07 October 2020