409P - Treatment of elderly patients (pts; > 75 years) with 1st-line ribociclib (RIB) + endocrine therapy (ET) or endocrine monotherapy in clinical routine: Real-world data from the RIBANNA study (5th interim analysis (IA))

Background

RIB+ET has demonstrated a statistically significant survival benefit across three phase 3 MONALEESA trials, irrespective of menopausal status, line of therapy, or combination partner. RIBANNA (CLEE011ADE03), a prospective, noninterventional study assessing the efficacy and safety of 1^st-line treatment options including RIB+ET in pre-, peri- and postmenopausal women with HR+, HER2– ABC is ongoing in Germany since October 2017. In this 5^th IA from RIBANNA, efficacy, safety, and tolerability for elderly pts will be presented.

Methods

Pts were included in accordance with the German tx guideline. For individual age subgroups (≤75 years; >75-80 years; >80 years) efficacy of RIB+ET vs. endocrine monotherapy will be compared by adjusting for baseline characteristics including Charlson comorbidity index. Furthermore, data for patient-reported outcomes (PRO) and treatment-emergent adverse events including time to onset, frequency, dose adjustment and outcome will be analyzed.

Results

At data cutoff Sep 6, 2022, for age subgroup ≤ 75 years, >75-80 years and for age subgroup >80 years data from n=1377 (RIB+ET) respectively n=109 (ET), n=281 (RIB+ET) respectively n=42 (ET), and n=153 (RIB+ET) respectively n=41 (ET) are available. The mean Charlson comorbidity index (standard deviation [SD]) increases with increasing age subgroup in the RIB+ET cohort (0.5 [1.2]; 0.8 [1.4]; 0.8 [1.3]) vs. ET cohort (0.6 [1.2]; 0.9 [1.5]; 0.9 [1.4]) respectively. Excluding interruptions, the mean daily RIB dose decreases with increasing age subgroups (527.7 mg vs. 504.8 mg vs. 471.3 mg). Most relevant differences in mPFS are seen in subgroup >75-80 (HR=0.555; 95% CI: 0.307-1.001; p=0.05). Overall number of treatment-emergent adverse events (all grade) in the RIB+ET cohort were similar between age subgroups (32.33% vs. 29.34% vs. 25.71%).

Conclusions

RIBANNA study showed diverse population characteristics among pts who received RIB tx in a real-world setting. For investigated age subgroups RIB+ET showed high efficacy over ET alone with manageable safety profile without new signals in the clinical routine.

Clinical trial identification

CLEE011ADE03.

Editorial acknowledgement

Legal entity responsible for the study

Novartis Pharma GmbH.

Funding

Novartis Pharma GmbH.

Disclosure

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 & 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, Pierre Fabre, 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, Advisory Board, Fees, 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. 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. 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.