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Lunch and Poster Display session

216P - What is driving treatment decision following 1st line ribociclib (RIB) + aromatase inhibitor (AI)/fulvestrant (FUL) in clinical routine? Real-world data from the RIBANNA study (6th interim analysis (IA))

Date

16 May 2024

Session

Lunch and Poster Display session

Presenters

Diana Luftner

Citation

Annals of Oncology (2024) 9 (suppl_4): 1-47. 10.1016/esmoop/esmoop103200

Authors

D.I. Luftner1, C. Brucker2, L.S.M. Dawkins3, T. Decker4, A. Engel5, P.A. Fasching6, T. Göhler7, C. Jackisch8, J. Janssen9, A. Koehler10, K. Luedtke-Heckenkamp11, F. Marmé12, M. Van Mackelenbergh13, B. Rautenberg14, T. Reimer15, M. Schmidt16, N. Voronina17, R. Weide18, P. Wimberger19, A. Woeckel20

Author affiliations

  • 1 MHB - Brandenburg Medical School Theodor Fontane - Institute of Social Medicine and Epidemiology, Brandenburg an der Havel/DE
  • 2 Klinikum Nürnberg, Paracelsus Medical University, Nürnberg/DE
  • 3 Novartis Pharma GmbH, 90429 - Nürnberg/DE
  • 4 Onkologie Hamatologie Ravensburg, Ravensburg/DE
  • 5 Winicker Norimed GmbH, Nurnberg/DE
  • 6 University Hospital Erlangen, Erlangen/DE
  • 7 Onkozentrum Dresden/Freiberg - Gemeinschaftspraxis Fachärzte für Innere Medizin, Dresden/DE
  • 8 Evangelische Kliniken Essen-Mitte gGmbH (KEM), Essen/DE
  • 9 Haematologie und Internistische Onkologie Praxis Westerstede, Westerstede/DE
  • 10 Practice for Hematology and Oncology, Langen (Hessen)/DE
  • 11 Franziskus-Hospital Harderberg - Niels-Stensen-KlinikenGmbH, Georgsmarienhütte/DE
  • 12 UMM - Universitaetsklinikum Mannheim - Medizinische Fakultaet, Mannheim/DE
  • 13 UKSH - Universitätsklinikum Schleswig-Holstein - Campus Kiel, Kiel/DE
  • 14 Universitätsklinikum Freiburg - Klinik für Strahlenheilkunde, 79106 - Freiburg im Breisgau/DE
  • 15 Klinikum Südstadt Rostock, Rostock/DE
  • 16 Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz/DE
  • 17 Novartis Pharma GmbH, Nürnberg/DE
  • 18 Praxis für Hämatologie und Onkologie Koblenz, Koblenz/DE
  • 19 Universitaetsklinikum Carl Gustav Carus Dresden, Dresden/DE
  • 20 UKW - University Hospital Würzburg, Würzburg/DE

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Abstract 216P

Background

RIBANNA is a German prospective, non-interventional study assessing the efficacy and safety of RIB + AI/FUL, endocrine therapy (ET) or chemotherapy (CT) in 1st line (1L) and subsequent therapy lines in pre-, peri-and postmenopausal women with HR+, HER2- advanced breast cancer. Real-world data on treatment sequence resulting from the 6th IA will be presented.

Methods

Patients (Pts) were treated according to German treatment guidelines and data on 1L and subsequent therapy lines were collected. Parameters that influence treatment decision for second-line (2L) therapy following 1L RIB were analysed including: Baseline characteristics, the median progression-free survival (mPFS) in 1L and patient-reported outcomes (EORTC QLQ-C30/BR23).

Results

At data cutoff (9. Oct 2023), 2113 pts were enrolled in the study (RIB + AI/FUL, n = 1799; ET, n = 179; CT, n = 135) and overall, 843 pts progressed to 2L therapy (median follow-up 2.9 years). Out of 709 pts (39.4%) with 1L RIB + AI/FUL having progressed, 89 pts also received RIB + AI/FUL as 2L therapy, 280 ET, 290 CT and 50 other treatments. Decision on 2L treatment seemed to be associated by the time to 1st progression, as 58% of pts with a 1L progression ≤ 6 months were in the RIB(1L)-CT(2L) group, whereas 59.8% of pts that progressed in 1L > 24 months were in the RIB-RIB or RIB-ET group. PFS analysis in 1L demonstrated that pts receiving 2L CT had the shortest mPFS (RIB-RIB, PFS = 14.5 months; RIB-ET, PFS = 19.4 months; RIB-CT PFS = 12.2 months). Also, TFI (time from the end of adjuvant therapy to disease recurrence) influenced 2L therapy decisions (TFI ≤ 12 months; RIB-RIB = 28.1%; RIB-ET = 27.5%; RIB-CT = 36.6%), suggesting a shorter TFI led more frequently to 2L CT. ECOG performance status at baseline, EORTC QLQ-C30/BR23 scores and incidence of AEs during RIB + AI/FUL 1L therapy of pts seemed to not influence 2L therapy decision.

Conclusions

Current data suggest, that 2L treatment decisions were influenced by the time to 1st progression/PFS and the TFI duration. Pts with a rapid progression (enriched in this analysis) were more likely treated with CT, than ET or RIB. Data will be analysed in the future once all pts have progressed in 1L.

Clinical trial identification

CLEE011ADE03.

Legal entity responsible for the study

Novartis Pharma GmbH.

Funding

Novartis Pharma GmbH.

Disclosure

D.I. Lüftner: Financial Interests, Personal, Advisory Board: AstraZeneca, Novartis, Pfizer, Daiichi Sankyo, Onkowissen, GSK; Financial Interests, Personal, Invited Speaker: Eli Lilly, Novartis, High5md, Loreal; Financial Interests, Institutional, Funding: Novartis. C. Brucker: Financial Interests, Personal, Advisory Board: Gedeon Richter ; Financial Interests, Personal, Other, Proctor: Intuitive Surgical. L.S.M. Dawkins: Financial Interests, Personal, Full or part-time Employment: Novartis. T. Decker: Financial Interests, Personal, Advisory Board: Novartis, IOMEDICO; Financial Interests, Personal, Invited Speaker: Novartis, Lilly. A. Engel: Financial Interests, Institutional, Full or part-time Employment, Contract Research Organisation: Winicker Norimed GmbH. P.A. Fasching: Financial Interests, Personal, Advisory Board: Roche, Novartis, Pfizer, Daiichi Sankyo, Eisai, Merck, Sharp & Dohme, AstraZeneca, Hexal, Lilly, Pierre Fabre, Seagen, Agendia, Sanofi Aventis, Medac, Menarini, Veracyte; Financial Interests, Personal, Invited Speaker: Novartis, Daiichi Sankyo, Eisai, Merck, Sharp & Dohme, AstraZeneca, Lilly, Seagen, Gilead, Mylan; Financial Interests, Personal, Other, Medical Writing Support: Roche; Financial Interests, Institutional, Invited Speaker: BionTech, Cepheid; Non-Financial Interests, Member: ASCO, Arbeitsgemeinschaft für Gynäkologische Onkologie e.V., Translational Research in Oncology, Deutsche Gesellschaft für Senologie e.v. C. Jackisch: Financial Interests, Personal, Invited Speaker: Roche, Exact Sciences, Gilead, Molecular Health; Financial Interests, Personal, Advisory Board: AstraZeneca, Novartis, Daiichi Sankyo, Pfizer. J. Janssen: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker, Speaker on DGHO Update and Advisory Board: Novartis; Financial Interests, Institutional, Invited Speaker: Novartis, Ipsen, Roche, BMS. A. Koehler: Financial Interests, Personal, Advisory Board: Roche, AbbVie, Daiichi Sankyo, Novartis, MSD, Amgen, Pfizer, Agendia; Financial Interests, Personal, Member of Board of Directors: Arbeitskreis Klinische Studien; Financial Interests, Institutional, Invited Speaker: Roche, Novartis, WSG. K. Luedtke-Heckenkamp: Financial Interests, Personal, Advisory Board: Roche, Daiichi Sankyo, Lilly; Financial Interests, Personal, Invited Speaker: Novartis, Gilead, Pfizer, AstraZeneca; Financial Interests, Institutional, Invited Speaker: Roche, Gilead, Daiichi Sankyo, Novartis, Pfizer, Seagen. F. Marmé: Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK/Tesaro, Clovis, Pfizer, Lilly; Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Novartis, Roche, Gilead/Immunomedics, Eisai, PharmaMar, GenomicHealth, Myriad, Seagen; Financial Interests, Institutional, Invited Speaker: Seagen, Daiichi Sankyo, GSK, AstraZeneca, Stemline Menarini, Roche, AstraZeneca, Novartis, Roche, Eisai, Gilead/Immunomedics, MSD, German Breast Group, AGO Research GmbH, Vaccibody, GSK; Financial Interests, Institutional, Advisory Board: Roche, Immunicom; Financial Interests, Institutional, Funding: AstraZeneca, Lilly, Seagen. M. Van Mackelenbergh: Financial Interests, Personal, Sponsor/Funding: AstraZeneca, Amgen, Daiichi Sankyo, Gilead, Eli Lilly, Molecular Health, Mylan, MSD, Novartis, Pfizer, Pierre Fabre, Roche, Seagen. B. Rautenberg: Financial Interests, Personal, Sponsor/Funding: Amgen, Novartis, Pfizer, Roche, Tesaro, Eli Lilly, MSD, Pierre Fabre. T. Reimer: Financial Interests, Personal, Invited Speaker: Novartis, Pfizer, Daiichi Sankyo, AstraZeneca, Roche; Financial Interests, Personal, Advisory Board: Pfizer. M. Schmidt: Financial Interests, Personal, Advisory Board: AstraZeneca, BioNTech, Daiichi Sankyo, Eisai, Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Roche, Seagen, Gilead; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Roche, Novartis, Pierre Fabre; Financial Interests, Personal, Invited Speaker: Pfizer. N. Voronina: Financial Interests, Personal, Full or part-time Employment: Novartis; Non-Financial Interests, Project Lead: Novartis. R. Weide: Financial Interests, Personal, Funding: AstraZeneca, BeiGene, Gilead, Incyte, Pierre Fabre, Roche, Seagen, Stemline, SOBI; Financial Interests, Personal and Institutional, Funding: Biotest, CSL Behring, Daiichi Sankyo, Eisai, Hexal, Medac, Takeda; Financial Interests, Institutional, Funding: Amgen, Celgene, GSK, Eli Lilly, Mundipharma, Octapharma. P. Wimberger: Financial Interests, Personal, Invited Speaker: AstraZeneca, Lilly GmbH, Roche GmbH, MSD, Eisai, GSK, Gilead, Pfizer, Novartis. A. Woeckel: Financial Interests, Personal, Advisory Board: AstraZeneca, • Novartis, Pfizer, Roche, MSD; Financial Interests, Personal, Invited Speaker: Lilly, Novartis, Pfizer, Gilead, Dajichi Sanko. All other authors have declared no conflicts of interest.

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