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Poster display session

2269 - A GINECO phase II study of Navitoclax (ABT 263) in women with platinum resistant/refractory recurrent ovarian cancer (ROC)

Date

09 Sep 2017

Session

Poster display session

Topics

Clinical Research;  Ovarian Cancer

Presenters

Pierre Emmanuel Brachet

Citation

Annals of Oncology (2017) 28 (suppl_5): v330-v354. 10.1093/annonc/mdx372

Authors

P.E. Brachet1, M. Fabbro2, A. Leary3, J. Medioni4, P. Follana5, A. Lesoin6, J. Frenel7, S. Abadie Lacourtoisie8, A. Floquet9, L. Gladieff10, B. You11, C. Gavoille12, E. Kalbacher13, M. Briand14, P. Just15, C. Blanc-Fournier16, A. Leconte17, J. Lequesne17, L. Poulain14, F. Joly Lobbedez1

Author affiliations

  • 1 Medical Oncology & Clinical Research & Inserm U1086 “anticipe” (interdisciplinary Research Unit For Cancers Prevention And Treatment, Axis Bioticla “biology And Innovative Therapeutics For Ovarian Cancers”),, UNICANCER, Centre François Baclesse & Normandie Univ, UNICAEN, 14076 - CAEN/FR
  • 2 Medical Oncology, UNICANCER, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR
  • 3 Medical Oncology, UNICANCER, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 4 Medical Oncology, AP-HP, Hopital European George Pompidou, 75015 - Paris/FR
  • 5 Medical Oncology, UNICANCER, Centre Antoine Lacassagne, 6100 - Nice/FR
  • 6 Medical Oncology, UNICANCER, Centre Oscar Lambret, 59020 - Lille/FR
  • 7 Medical Oncology, UNICANCER, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 8 Medical Oncology, UNICANCER, Institut de Cancérologie de l'Ouest site Paul Papin, 49100 - Angers/FR
  • 9 Medical Oncology, UNICANCER,, Institute Bergonié, 33076 - Bordeaux/FR
  • 10 Medical Oncology, UNICANCER, Institut Claudius Regaud- IUCT-Oncopole, 31059 - Toulouse/FR
  • 11 Medical Oncology, Centre Hospitalier Lyon Sud, 69495 - Pierre Bénite/FR
  • 12 Medical Oncology, UNICANCER, Institut de Cancérologie de Lorraine - Alexis Vautrin, 54519 - Vandoeuvre les Nancy/FR
  • 13 Medical Oncology, CHU Besançon, Hôpital Jean Minjoz, 25030 - Besançon/FR
  • 14 Inserm U1086 “anticipe” (interdisciplinary Research Unit For Cancers Prevention And Treatment, Axis Bioticla “biology And Innovative Therapeutics For Ovarian Cancers”),, UNICANCER, Centre François Baclesse & Normandie Univ, UNICAEN, 14076 - CAEN/FR
  • 15 Service De Pathologie, APHP, site Cochin, 75014 - PARIS/FR
  • 16 Department Of Anatomo-pathology & Inserm U1086 “anticipe” (interdisciplinary Research Unit For Cancers Prevention And Treatment, Axis Bioticla “biology And Innovative Therapeutics For Ovarian Cancers”),, UNICANCER, Centre François Baclesse & Normandie Univ, UNICAEN, 14076 - CAEN/FR
  • 17 Department Of Clinical Research, UNICANCER, Centre François Baclesse, 14076 - CAEN/FR
More

Resources

Abstract 2269

Background

Among ovarian cancer patients with early relapse after platinum chemotherapy, there is no convincing active treatment. In preclinical studies, we previously demonstrated promising activity of Navitoclax (ABT-263), an anti-apoptotic inhibitor of Bcl-2 family, in ROC tumors, suggesting a potential action in platinum resistant patients. In this prospective multicentric phase II study, we evaluated the efficacy of Navitoclax monotherapy in heavily pretreated ROC patients.

Methods

This study included high grade serous patients with platinum resistance. Navitoclax was orally administered at 150 mg/day during a lead in period (7 to 14 days) and then increased to 250 mg in the absence of dose-limiting thrombocytopenia (

Results

From January to September 2016, 47 patients were included in 13 institutions and 46 patients were analysed: 44 ovarian carcinomas, 1 peritoneal carcinoma and 1 fallopian tube, median age 63 (38-80); BRCA1/2 mutations (n = 7), negative (n = 25) and unknown (n = 14). The median number of prior treatment lines was 4 (2-12). PFS was 50 days [6-234] with 1 partial response (PR), 15 stable diseases (SD). Thrombocytopenia was the major expected side effect, with G3 (n = 11) and G4 (n = 1) leading to maintain the dose at 150 mg for 8 patients and to treatment discontinuation for 3 patients. Neither significant bleeding nor toxic death was observed. 26 patients were treated after progression, 23 with chemotherapy (10 receiving platinum agent): among the 21 evaluable patients, 1 PR and 8 SD were observed, including 6 patients treated with platinum, with 3 long responders (7 to 9 months). No BRCA mutation was observed among the responders.

Conclusions

Navitoclax monotherapy had modest activity without unacceptable toxicity. However, as shown by response to treatment after progression, Navitoclax may reverse platinum resistance in ROC patients. Complementary biological data in progress may help select patients who could benefit from Navitoclax.

Clinical trial identification

EudraCT number: 2015-000193-35 Clinical Trial Number: N° NCT02591095

Legal entity responsible for the study

Centre François Baclesse - CAEN

Funding

The French Cancer Research Hospital Program in 2011 & the Mariapia Bressan award in GINEGEPS 2014 Drug supply has been provided by Abbvie Laboratory

Disclosure

All authors have declared no conflicts of interest.

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