drugset / Trial / NCT02477644
Platine, Avastin and OLAparib in 1st Line
Phase 3
Completed
806 enrolled
Arcagy Research
Arbeitsgemeinschaft Gynaekologische Onkologie Austria · collabArbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany · collabBelgian Gynaecological Oncology Group · collabGrupo Español de Investigación en Cáncer de Ovario · collabGynecologic Oncology Trial & Investigation Consortium · collabMario Negri Gynecologic Oncology group (MaNGO) · collabMulticenter Italian Trials in Ovarian cancer and gynecologic malignancies · collabNordic Society of Gynaecological Oncology - Clinical Trials Unit · collab
RandomizedParallel-groupTriple-blindTreatment
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
Outcome
Met primary endpoint
paper median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab PMID 31851799 ↗
paper (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P<0.001). PMID 31851799 ↗
release “PAOLA-1 met its primary endpoint, significantly reducing the risk of disease progression or death” merck.com ↗
release “The PAOLA-1 Phase III trial showed that Lynparza, in combination with bevacizumab maintenance treatment, reduced the risk of disease progression or death by 67%” astrazeneca.com ↗
release “PAOLA-1 Phase III trial showed that Lynparza , in combination with bevacizumab maintenance treatment, reduced the risk of disease progression” astrazeneca.com ↗
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaparib | Small molecule | 300 mg | Oral |