Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Discussion – Gynaecological cancers

4350 - Time to second progression (PFS2) and second subsequent therapy (TSST) for patients (pts) with newly diagnosed, advanced ovarian cancer (OC) and a BRCA mutation (BRCAm) treated with maintenance (mt) olaparib (ola) – Phase III SOLO1 trial

Date

29 Sep 2019

Session

Poster Discussion – Gynaecological cancers

Presenters

Ana Oaknin

Citation

Annals of Oncology (2019) 30 (suppl_5): v403-v434. 10.1093/annonc/mdz250

Authors

A. Oaknin1, K. Moore2, N. Colombo3, G. Scambia4, B. Kim5, M. Friedlander6, A. Lisyanskaya7, A. Floquet8, A. Leary9, G.S. Sonke10, C. Gourley11, S. Banerjee12, A.M. Oza13, A. González-Martín14, C. Aghajanian15, W. Bradley16, E.S. Lowe17, R. Bloomfield18, P. DiSilvestro19

Author affiliations

  • 1 Medical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), 08035 - Barcelona/ES
  • 2 Section Of Gynecologic Oncology, Stephenson Oklahoma Cancer Center, - - Oklahoma/US
  • 3 Gynecologic Oncology, University of Milan-Bicocca and Istituto Europeo di Oncologia, 20141 - Milan/IT
  • 4 Gynecologic Oncology Unit, Università Cattolica del Sacro Curoe-Fondazione Policlinico A. Gemelli, IRCCS, Rome/IT
  • 5 Department Of Medical Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul/KR
  • 6 Department Of Medicine, University of New South Wales Clinical School, Prince of Wales Hospital, Sydney/AU
  • 7 Department Of Medical Oncology, St Petersburg City Oncology Dispensary, St Petersburg/RU
  • 8 Department Of Medical Oncology, Institut Bergonié, Comprehensive Cancer Centre and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, 33076 - Bordeaux/FR
  • 9 Gynecologic Unit, Gustave Roussy Cancer Center and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Villejuif/FR
  • 10 Department Of Medical Oncology, The Netherlands Cancer Institute, 1066 CX - Amsterdam/NL
  • 11 Nicola Murray Centre For Ovarian Cancer Research, Cancer Research UK Edinburgh Centre, University of Edinburgh, EH4 2XR - Edinburgh/GB
  • 12 Department Of Gynaecology, The Royal Marsden Hospital NHS Foundation Trust and Institute of Cancer Research, SW3 6JJ - London/GB
  • 13 Division Of Medical Oncology And Hematology, Princess Margaret Cancer Centre, Toronto/CA
  • 14 Department Of Medical Oncology, Clínica Universidad de Navarra, Madrid/ES
  • 15 Department Of Medical Oncology, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
  • 16 Department Of Medical Oncology, Froedtert and the Medical College of Wisconsin, Milwaukee/US
  • 17 Drug Development Department, AstraZeneca, Gaithersburg/US
  • 18 Drug Development Department, AstraZeneca, Cambridge/GB
  • 19 Department Of Medical Oncology, Women & Infants Hospital, Providence/US
More

Resources

Abstract 4350

Background

SOLO1 (NCT01844986; GOG-3004) pts with newly diagnosed, advanced OC and a BRCAm treated with mt ola had a substantial progression-free survival benefit vs placebo (pbo) (HR 0.30 [95% CI 0.23–0.41], P < 0.001; Moore et al. NEJM 2018). The impact of first line use of PARP inhibitors (PARPi) on subsequent therapy is of clinical interest. Secondary objectives included PFS2 and TSST, which indicate the effect of treatment beyond first progression.

Methods

Pts were randomized 2:1 to ola 300 mg bid or pbo for up to 2 years or until disease progression. After first progression, PFS2 was assessed every 12 weeks (radiological, CA125 or clinical progression).

Results

There were 121 PFS2 events (HR 0.50, 95% CI 0.35–0.72, median PFS2 was not reached (NR) [ola] vs 41.9 months [m; pbo]). Median TSST was NR (ola) vs 40.7 m (pbo; HR 0.45, 95% CI 0.32–0.63). Based on Kaplan-Meier estimates, at 36 m, the proportions of ola pts free from second progression or second therapy were 15 and 18 percentage points higher respectively, than the proportions of pbo pts (Table).Table: 995PD

Kaplan-Meier estimates of pts free from second disease progression (%)Kaplan-Meier estimates of pts free from second subsequent therapy (%)
Time from randomization (m)Olaparib n = 260Placebo n = 131Olaparib n = 260Placebo n = 131
1296959795
2486778569
3675607456

Of 198 pts who progressed, 91/102 in the ola arm and 94/96 in the pbo arm had a subsequent therapy or therapies: the most common therapies were platinum (plat)-based chemotherapy (chemo) (n = 58 [64%] vs n = 50 [53%]), including plat with bevacizumab (bev) (n = 22 [24%] vs n = 15 [16%]); PARPi, including plat followed by PARPi (n = 20 [22%] vs n = 49 [52%]); and non-plat chemo (excluding regimens with bev) (n = 35 [38%] vs n = 26 [28%]). In the ola arm, 10 pts had ola as part of their first subsequent therapy (9 had ola as mt following plat-based chemo) and 3 progressed for a second time. In the pbo arm, 44 (47%) pts who had subsequent therapy had ola outside the study.

Conclusions

Mt ola increases both PFS2 and TSST vs pbo. The benefit of mt ola in newly diagnosed OC continues beyond first progression.

Clinical trial identification

NCT01844986.

Editorial acknowledgement

Laura Smart, from Mudskipper Business, Ltd, funded by AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, U.S.A. (MSD).

Legal entity responsible for the study

AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, U.S.A. (MSD).

Funding

AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, U.S.A. (MSD).

Disclosure

A. Oaknin: Advisory / Consultancy: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Pharmamar; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Immunogen; Advisory / Consultancy: Genmab. K. Moore: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Advaxis; Advisory / Consultancy: Clovis; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Genentech/Roche; Advisory / Consultancy: Immunogen; Advisory / Consultancy: VBL Therapeutics; Advisory / Consultancy: Merck; Advisory / Consultancy: Janssen; Advisory / Consultancy: Aravive; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Eisai; Advisory / Consultancy: Samumed; Advisory / Consultancy: Oncomed. N. Colombo: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Tesaro; Honoraria (self), Advisory / Consultancy: PharmaMar; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Pfizer. M. Friedlander: Honoraria (self), Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: MSD; Advisory / Consultancy: Lilly; Advisory / Consultancy: Takeda; Non-remunerated activity/ies: AbbVie. A. Floquet: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Clovis Oncology; Honoraria (self): Roche; Honoraria (self): PharmaMar; Honoraria (self), Advisory / Consultancy: Tesaro. A. Leary: Honoraria (self), Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Biocad; Advisory / Consultancy: Seattle Genetics. G.S. Sonke: Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): Roche; Research grant / Funding (self): Merck; Research grant / Funding (self): Novartis. C. Gourley: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Tesaro; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Nucana; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Clovis Oncology; Honoraria (self), Advisory / Consultancy: Foundation One; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Sierra Oncology; Research grant / Funding (self): Novartis; Research grant / Funding (self): Aprea. S. Banerjee: Honoraria (self), Research grant / Funding (self): AstraZeneca; Honoraria (self): Tesaro; Honoraria (self): Clovis Oncology; Honoraria (self): Merck; Honoraria (self): PharmaMar; Honoraria (self): Roche; Honoraria (self): Seattle Genetics; Honoraria (self): Nucana. A.M. Oza: Non-remunerated activity/ies, Steering committee: AstraZeneca; Non-remunerated activity/ies, Steering committee: Clovis Oncology; Non-remunerated activity/ies, Steering committee: Tesaro. A. González-Martín: Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Tesaro; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Immunogen; Advisory / Consultancy: Genmab; Advisory / Consultancy: MSD; Advisory / Consultancy: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: PharmaMar. C. Aghajanian: Honoraria (self): Tesaro; Honoraria (self): ImmunoGen; Honoraria (self): Clovis Oncology. E.S. Lowe: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. R. Bloomfield: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. P. DiSilvestro: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Tesaro. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.