411P - Therapy management and safety of 1st-line ribociclib (RIB) + aromatase inhibitor (AI)/fulvestrant (FUL) in clinical routine: Real-world data from the RIBANNA study (5th interim analysis (IA))

Background

RIBANNA (CLEE011ADE03) is a prospective, noninterventional study assessing the efficacy and safety of RIB+AI/FUL, endocrine therapy (ET) alone, or chemotherapy (CT) in 1L and subsequent therapy lines in pre-, peri- and postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer. Herein we present real-world data on therapy management for RIB, including therapy-related adverse events (AEs), dose adjustment, and efficacy outcomes in special subgroups resulting from the 5th IA from RIBANNA.

Methods

Pre-, peri- and postmenopausal patients within the study were treated according to German treatment guidelines. For the RIB cohort the number of dose adjustments, reason and time until dose adjustment and/or discontinuation will be presented. Effectiveness analysis for PFS in 1L will be performed for patients with and without dose adjustments. Safety analysis and the median time to toxicity will be explored, with focus on AEs of special interest (AESIs): liver toxicity, cardiac events and neutropenia.

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). The mean RIB exposure (standard deviation [SD]) in 1L was 597.7 [459.2] days with a mean daily dose of 280.7 [132.3] mg/day and 519.1 [117.4] mg/day including and excluding interruptions, respectively. The unadjusted KM estimate for median PFS was 32.2 months (95% CI, 29.3–34.8) in the RIB + AI/FUL cohort. Regarding the AESIs (all grade): an increased alanine- and aspartate-aminotransferase was recorded in 3.9% (78) and 3.8% (75) of patients, respectively. Similarly, 3.7% (73) of patients had a prolonged QT interval on the electrocardiogram. Neutropenia was documented for 25.8% (511) of the patients, being one of the most frequent treatment-emergent adverse events.

Conclusions

The RIBANNA study encompasses a diverse patient population receiving RIB therapy. Data on the 1L therapy management in real-world settings including dose adjustments, efficacy in special populations and safety 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

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. 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, Other, Personal Fees, Honoraria or Travel grants: Amgen, AstraZeneca, Daiichi Sankyo, Genomic Health, Gilead, GSK, Lilly, Molecular Health, MSD, Mylan, Novartis, Pfizer, PierreFabre, Roche, Seagen. B. Rautenberg: Financial Interests, Personal, Advisory Board, Honoraria, congress/travel grants: Novartis, Roche, Daiichi Sankyo, Lilly, MSD. 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. 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. A. Woeckel: Financial Interests, Personal, Advisory Board: AstraZeneca, Novartis, Pfizer, Roche, MSD; Financial Interests, Personal, Invited Speaker: Lilly, Novartis, Pfizer, Gilead, Daiichi Sanko. All other authors have declared no conflicts of interest.