441P - Real-world efficacy of ribociclib (RIB) + aromatase inhibitor (AI)/fulvestrant (FUL) in subgroups of special interest: 5th interim analysis (IA) of the RIBANNA study

Background

RIBANNA (CLEE011ADE03) is a prospective, noninterventional study assessing the efficacy and safety of RIB+AI/FUL, or endocrine therapy (ET) or chemotherapy (CT) in pre-, peri- and postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC) in a broad patient population. Real-world data on the efficacy of RIB in subgroups of special interest resulting from the 5^th IA from the RIBANNA study will be presented at the conference.

Methods

Efficacy outcomes in subgroups of special interest will be determined. Adjusted progression-free survival (PFS) for 1L RIB will be separately analyzed for patients with visceral vs. non-visceral metastases (lung, liver, central nervous system), pre- vs postmenopausal patients, patients receiving AI vs FUL as Ribociclib combination partner, de novo vs. recurrent and endocrine-resistant vs. -sensitive disease. In addition, conditional PFS (this is, the probability of survival without progression for further months given a previous survival for a defined number of months) will be analyzed for patients without progression at 6, 12, and 24 months in the overall study population.

Results

At data cutoff Sep 6, 2022, 2581 patients were enrolled in the study (RIB+AI/FUL, n = 2163; ET, n = 237; CT, n = 181). At baseline there were 189 pre/peri and 1605 postmenopausal patients and 750 patients with visceral metastases in the RIB cohort included in the study. 1566 patients received AI and 415 received FUL in the RIB cohort at baseline. At study start 381 de novo and 1765 recurrent patients were included over all treatment cohorts. The unadjusted KM estimate for median PFS was 32.2 months (95% CI, 29.3–34.8) in the RIB + AI/FUL cohort. Herein, efficacy data (PFS, conditional PFS) in the specified patient subgroups will be presented.

Conclusions

The RIBANNA study analyses the use of RIB in a diverse patient population in the clinical routine. RIB showed efficacy superiority over ET and CT in the overall patient population. Data on the real-world efficacy of specific patient subgroups will be presented at the conference.

Clinical trial identification

CLEE011ADE03.

Editorial acknowledgement

Legal entity responsible for the study

Novartis Pharma GmbH.

Funding

Novartis Pharma GmbH.

Disclosure

A. Woeckel: Financial Interests, Personal, Advisory Board: AstraZeneca, • Novartis, Pfizer, Roche, MSD; Financial Interests, Personal, Invited Speaker: Lilly, Novartis, Pfizer, Gilead, Daiichi Sanko. T. Decker: Financial Interests, Personal, Advisory Board: Novartis, IOMEDICO; Financial Interests, Personal, Invited Speaker: Novartis, Lilly. P. Fasching: Financial Interests, Personal, Advisory Board: Roche, Novartis, Pfizer, Daiichi Sankyo, Eisai, Merck, Sharp & Dohme, AstraZeneca, Hexal, Lilly, Pierre Fabre, Seagen, Agendia, Sanofi Aventis; Financial Interests, Personal, Invited Speaker: Novartis, Daiichi Sankyo, Eisai, Merck, Sharp & Dohme, AstraZeneca, Lilly, Seagen, Gilead; Financial Interests, Personal, Other, Medical Writing Support: Roche; Financial Interests, Institutional, Local PI: 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: AstraZeneca, Eigene, BMS, Ibsen, Johnson & Johnson, Janssen Oncology, Lilly, Novartis, Roche; Financial Interests, Institutional, Local PI: AstraZeneca, Eigene, BMS, Ibsen, Johnson , Janssen , Lilly, Novartis, Roche. A. Koehler: Financial Interests, Personal, Advisory Board: Roche, Novartis, Pfizer, Amgen, Daiichi Sankyo, MSD. K. Luedtke-Heckenkamp: Financial Interests, Personal, Advisory Board: Roche, Daiichi Sankyo, Lilly; Financial Interests, Personal, Invited Speaker: Novartis, Gilead, Pfizer, AstraZeneca; Financial Interests, Institutional, Local PI: Roche, Gilead, Daiichi Sankyo, Novartis, Pfizer, Seagen. D. 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. M. Van Mackelenbergh: Financial Interests, Personal, Advisory Board, Personal Fees, Honoraria or Travel grants: Amgen, AstraZeneca, Daiichi Sankyo, Genomic Health, Gilead, GSK, Lilly, Molecular Health, MSD, Mylan, Novartis, Pfizer, PierreFabre, Roche, 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; Financial Interests, Institutional, Advisory Board: Roche, Immunicom; Financial Interests, Institutional, Local PI: Roche, Novartis, Eisai, MSD, Vaccibody, GSK; Financial Interests, Institutional, Coordinating PI: AstraZeneca, Roche, Gilead/Immunomedics, German Breast Group, AGO Research GmbH; Financial Interests, Institutional, Funding: AstraZeneca, Lilly, Seagen. B. Rautenberg: Financial Interests, Personal, Other, Honoraria, congress/travel grants: Novartis, Roche, Daiichi Sankyo, Lilly, MSD. T. Reimer: Financial Interests, Personal, Invited Speaker: Novartis, Pfizer, Daiichi Sankyo, AstraZeneca, Roche; Financial Interests, Personal, Advisory Board: Pfizer. R. Weide: Financial Interests, Institutional, Funding: Amgen, Biotest, Celgene, CSL Behring, Daiichi Sankyo, Eisai, GSK, Hexal, Lilly, Medac, Mundipharma, Octapharma, Takeda. P. Wimberger: Financial Interests, Personal, Invited Speaker: AstraZeneca, Lilly GmbH, Roche GmbH, MSD, Eisai, GSK, Gilead, Pfizer, Novartis. S. Maslanka Figueroa: Financial Interests, Personal, Full or part-time Employment: Novartis. C. Roos: Financial Interests, Personal, Full or part-time Employment: Novartis Pharma GmbH. M. Schmidt: Financial Interests, Personal, Advisory Board: AstraZeneca, BioNTech, Daiichi Sankyo, Eisai, Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Roche, SeaGen; Financial Interests, Institutional, Local PI: AstraZeneca, Roche, Novartis, Pierre Fabre; Financial Interests, Personal, Trial Chair: Pfizer. All other authors have declared no conflicts of interest.