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 Display session 2

1423 - Palbociclib plus fulvestrant as second- or later-line therapy for patients with locally advanced, inoperable or metastatic HR+/HER2- breast cancer in Germany: Interim results of the INGE-B phase 2 study

Date

29 Sep 2019

Session

Poster Display session 2

Topics

Tumour Site

Breast Cancer

Presenters

Diana Lüftner

Citation

Annals of Oncology (2019) 30 (suppl_5): v104-v142. 10.1093/annonc/mdz242

Authors

D. Lüftner1, M.K. Welslau2, R. Liersch3, M. Deryal4, C. Brucker5, J. Rauh6, A. Welt7, M. Zaiss8, J. Sahlmann9, L. Houet10, C. Vannier10, K. Potthoff10, N.W. Marschner10

Author affiliations

  • 1 Medizinische Klinik Iii, Charite, Campus Benjamin Franklin Medizinische Klinik III, 12200 - Berlin/DE
  • 2 Onkologie, Klinikum Aschaffenburg, 63739 - Aschaffenburg/DE
  • 3 Hämatologie Und Onkologie, Hämatologische-Onkologische Gemeinschaftspraxis, 48149 - Münster/DE
  • 4 Frauenklinik, Caritasklinik St. Theresia, 66113 - Saarbrücken/DE
  • 5 Frauenheilkunde, Klinik Viii, Klinikum Nürnberg, 20143 - Nürnberg/DE
  • 6 Innere Medizin, Gemeinschaftspraxis Innere Medizin, 58455 - Witten/DE
  • 7 Innere Klinik (tumorforschung), University Hospital Essen Westdeutsches Tumorzentrum, 45147 - Essen/DE
  • 8 Praxis Für Interdisziplinäre Onkologie, Praxis für Interdisziplinaere Onkologie, 79110 - Freiburg/DE
  • 9 Department Of Data Management, Statistics And Medical Informatics, iOMEDICO AG, 79106 - Freiburg im Breisgau/DE
  • 10 Medical Department, iOMEDICO AG, 79106 - Freiburg im Breisgau/DE

Resources

Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 1423

Background

In the PALOMA-3 trial, palbociclib plus fulvestrant demonstrated a clinically meaningful improvement in overall survival compared with fulvestrant plus placebo in patients (pts) with hormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer who had relapsed or progressed on prior endocrine therapy (Turner NC et al., NEJM 2018). Detailed analyses for first-line (1L) and second- or later- line (2L+) therapy are still limited.

Methods

The prospective, multicenter phase 2 INGE-B trial was designed to generate efficacy and safety data on the combination of palbociclib with letrozole (1L) or fulvestrant (1L, 2L+) in accordance with the PALOMA trials and to generate so far lacking trial data on the combination of palbociclib with anastrozole (1L), exemestane (1L) or letrozole (2L+). This pre-planned interim analysis was conducted to evaluate data on pts receiving palbociclib plus fulvestrant as 1L or 2L+ therapy. The primary endpoint was the clinical benefit rate (CBR) in pts with measurable disease according to RECIST v1.1. Key secondary endpoints included the overall response rate (ORR), the CBR for all pts, and safety. Data were analyzed with descriptive statistics.

Results

At the cut-off date of the interim analysis (Dec 17, 2018), 124 pts have been recruited from 03/2017 through 06/2018 at 47 sites across Germany to receive palbociclib plus fulvestrant (1L: 57 pts; 2L+: 67 pts). 57 of 67 pts treated in 2L+ were evaluable. Median age was 68.0 years, 91.2% (n = 52) of pts had an ECOG performance score of 0 or 1. 28.1% (n = 16) of pts presented with non-measurable bone-only disease. The CBR was 35% (n = 14) for the 40 pts with measurable disease (RECIST v1.1) and 51% (n = 29) for all pts (investigator assessment). The ORRs were 25% (n = 10) and 21% (n = 12), respectively. Grade 3/4 adverse events experienced by at least 10% of pts were neutropenia (n = 21, 36.8%) and leukopenia (n = 7, 12.3%).

Conclusions

This INGE-B interim analysis showed a remarkable clinical benefit for palbociclib plus fulvestrant as second- or later-line therapy for pts with HR+/HER2- advanced breast cancer. No new safety signals were detected.

Clinical trial identification

2015-001603-32.

Editorial acknowledgement

Legal entity responsible for the study

iOMEDICO AG.

Funding

Pfizer Pharma GmbH.

Disclosure

D. Lüftner: Advisory / Consultancy, Research grant / Funding (institution): Amgen; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Celgene; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Teva; Advisory / Consultancy: Tesaro; Advisory / Consultancy: L’Oréal; Advisory / Consultancy: MSD; Advisory / Consultancy: AstraZeneca. M.K. Welslau: Honoraria (self), Advisory / Consultancy: Amgen; Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: GILEAD; Honoraria (self), Advisory / Consultancy: HEXAL; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Medac; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self): Astellas; Honoraria (self): AstraZeneca. A. Welt: Advisory / Consultancy: Roche; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Eisai; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Amgen. M. Zaiss: Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Celgene; Advisory / Consultancy: Janssen; Advisory / Consultancy: Novartis. N.W. Marschner: Leadership role, Shareholder / Stockholder / Stock options: iOMEDICO AG; Research grant / Funding (institution): Pfizer. 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.