Platine, Avastin and OLAparib in 1st Line

Summary

Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.

Timeline

Start

2015-05-06

Primary completion

2019-03-22

Completion

2022-03-22

Publications

• Results Ray-Coquard I, Pautier P, Pignata S, Perol D, Gonzalez-Martin A, Berger R, Fujiwara K, Vergote I, Colombo N, Maenpaa J, Selle F, Sehouli J, Lorusso D, Guerra Alia EM, Reinthaller A, Nagao S, Lefeuvre-Plesse C, Canzler U, Scambia G, Lortholary A, Marme F, Combe P, de Gregorio N, Rodrigues M, Buderath P, Dubot C, Burges A, You B, Pujade-Lauraine E, Harter P; PAOLA-1 Investigators. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361.
• Joly F, Anota A, Chabaud S, Cropet C, Priou F, Harter P, Pignata S, Palacio I, Petru E, Kobayashi H, Vergote I, Parma G, Maenpaa J, Raymond E, Ataseven B, Pisano C, Lainez N, Tsibulak I, Yonemori K, Vuylsteke P, Lapresa MT, Mirza MR, Bouchaert P, Buderath P, Lorusso D, Herrero A, Eberst L, Burges A, Scambia G, Ortega E, Guillemet C, Pujade-Lauraine E, Kurtz JE, Ray-Coquard I. Health-related quality of life in patients with newly diagnosed advanced ovarian cancer receiving maintenance olaparib plus bevacizumab (PAOLA-1/ENGOT-ov25). J Natl Cancer Inst. 2026 Apr 24:djag122. doi: 10.1093/jnci/djag122. Online ahead of print.
• Barnicle A, Ray-Coquard I, Rouleau E, Cadoo K, Simpkins F, Aghajanian C, Leary A, Poveda A, Lheureux S, Pujade-Lauraine E, You B, Ledermann J, Matulonis U, Gourley C, Timms KM, Lai Z, Hodgson DR, Elks CE, Dearden S, Egile C, Lao-Sirieix P, Harrington EA, Brown JS. Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib. Genome Med. 2024 Dec 18;16(1):145. doi: 10.1186/s13073-024-01413-5.
• Montegut C, Falandry C, Cinieri S, Cropet C, Montane L, Rousseau F, Joly F, Moubarak M, Mosconi AM, Guerra-Alia EM, Schauer C, Fujiwara H, Vergote I, Parma G, Lindahl G, Anota A, Canzler U, Marme F, Pujade-Lauraine E, Ray-Coquard I, Sabatier R. Safety and quality of life with maintenance olaparib plus bevacizumab in older patients with ovarian cancer: subgroup analysis of PAOLA-1/ENGOT-ov25. Oncologist. 2025 Jul 4;30(7):oyae322. doi: 10.1093/oncolo/oyae322.
• Harter P, Marth C, Mouret-Reynier MA, Cropet C, Lorusso D, Guerra-Alia EM, Matsumoto T, Vergote I, Colombo N, Maenpaa J, Lebreton C, de Gregorio N, Mosconi AM, Rubio-Perez MJ, Bourgeois H, Fasching PA, Cecere SC, Hardy-Bessard AC, Denschlag D, de Percin S, Hanker L, Favier L, Bauerschlag D, Desauw C, Hillemanns P, Largillier R, Sehouli J, Grenier J, Pujade-Lauraine E, Ray-Coquard I; PAOLA-1/ENGOT-ov25 investigators. Efficacy of subsequent therapies in patients with advanced ovarian cancer who relapse after first-line olaparib maintenance: results of the PAOLA-1/ENGOT-ov25 trial. Ann Oncol. 2025 Feb;36(2):185-196. doi: 10.1016/j.annonc.2024.10.828. Epub 2024 Nov 9.
• Lorusso D, Mouret-Reynier MA, Harter P, Cropet C, Caballero C, Wolfrum-Ristau P, Satoh T, Vergote I, Parma G, Nottrup TJ, Lebreton C, Fasching PA, Pisano C, Manso L, Bourgeois H, Runnebaum I, Zamagni C, Hardy-Bessard AC, Schnelzer A, Fabbro M, Schmalfeldt B, Berton D, Belau A, Lotz JP, Gropp-Meier M, Gladieff L, Luck HJ, Abadie-Lacourtoisie S, Pujade-Lauraine E, Ray-Coquard I. Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial. Int J Gynecol Cancer. 2024 Apr 1;34(4):550-558. doi: 10.1136/ijgc-2023-004995.
• Callens C, Rodrigues M, Briaux A, Frouin E, Eeckhoutte A, Pujade-Lauraine E, Renault V, Stoppa-Lyonnet D, Bieche I, Bataillon G, Karayan-Tapon L, Rochelle T, Heitz F, Cecere SC, Perez MJR, Grimm C, Nottrup TJ, Colombo N, Vergote I, Yonemori K, Ray-Coquard I, Stern MH, Popova T. Shallow whole genome sequencing approach to detect Homologous Recombination Deficiency in the PAOLA-1/ENGOT-OV25 phase-III trial. Oncogene. 2023 Nov;42(48):3556-3563. doi: 10.1038/s41388-023-02839-8. Epub 2023 Nov 9.
• Pujade-Lauraine E, Brown J, Barnicle A, Wessen J, Lao-Sirieix P, Criscione SW, du Bois A, Lorusso D, Romero I, Petru E, Yoshida H, Vergote I, Colombo N, Hietanen S, Provansal M, Schmalfeldt B, Pignata S, Martin Lorente C, Berton D, Runnebaum IB, Ray-Coquard I. Homologous Recombination Repair Gene Mutations to Predict Olaparib Plus Bevacizumab Efficacy in the First-Line Ovarian Cancer PAOLA-1/ENGOT-ov25 Trial. JCO Precis Oncol. 2023 Jan;7:e2200258. doi: 10.1200/PO.22.00258.
• Gonzalez-Martin A, Desauw C, Heitz F, Cropet C, Gargiulo P, Berger R, Ochi H, Vergote I, Colombo N, Mirza MR, Tazi Y, Canzler U, Zamagni C, Guerra-Alia EM, Levache CB, Marme F, Bazan F, de Gregorio N, Dohollou N, Fasching PA, Scambia G, Rubio-Perez MJ, Milenkova T, Costan C, Pautier P, Ray-Coquard I; PAOLA1/ENGOT-ov25 investigators. Maintenance olaparib plus bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: Main analysis of second progression-free survival in the phase III PAOLA-1/ENGOT-ov25 trial. Eur J Cancer. 2022 Oct;174:221-231. doi: 10.1016/j.ejca.2022.07.022. Epub 2022 Sep 5.
• Fujiwara K, Fujiwara H, Yoshida H, Satoh T, Yonemori K, Nagao S, Matsumoto T, Kobayashi H, Bourgeois H, Harter P, Mosconi AM, Vazquez IP, Reinthaller A, Fujita T, Rowe P, Pujade-Lauraine E, Ray-Coquard I. Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial. J Gynecol Oncol. 2021 Sep;32(5):e82. doi: 10.3802/jgo.2021.32.e82.

Drugs

Indications