Real-world efficacy of ribociclib (RIB) plus aromatase inhibitor (AI)/fulvestrant (FUL), or endocrine monotherapy (ET), or chemotherapy (CT) as first-line (1L) treatment (tx) in patients (pts) with hormone receptor–positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancer (ABC): Results of fourth interim analysis (IA) from RIBANNA.

person Diana Lüftner Charité University Hospital, Berlin, Germany info_outline Diana Lüftner, Cosima Brucker, Thomas Decker, Peter A. Fasching, Thomas Göhler, Christian Jackisch, Jan Janssen, Andreas Koehler, Kerstin Luedtke-Heckenkamp, Marion Van Mackelenbergh, Frederik Marmé, Arnd Nusch, Beate Rautenberg, Toralf Reimer, Marcus Schmidt, Rudolf Weide, Pauline Wimberger, Naiba Nabieva, Christian Roos, Achim Woeckel

Authors person Diana Lüftner Charité University Hospital, Berlin, Germany info_outline Diana Lüftner, Cosima Brucker, Thomas Decker, Peter A. Fasching, Thomas Göhler, Christian Jackisch, Jan Janssen, Andreas Koehler, Kerstin Luedtke-Heckenkamp, Marion Van Mackelenbergh, Frederik Marmé, Arnd Nusch, Beate Rautenberg, Toralf Reimer, Marcus Schmidt, Rudolf Weide, Pauline Wimberger, Naiba Nabieva, Christian Roos, Achim Woeckel Organizations Charité University Hospital, Berlin, Germany, Klinikum Nürnberg Nord, Nürnberg, Germany, Onkologie Ravensburg, Ravensburg, Germany, University Hospital Erlangen, Erlangen, Germany, Onkozentrum Dresden/Freiberg, Dresden, Germany, Sana Klinikum Offenbach, Offenbach, Germany, Medizinische Studiengesellschaft Nord-West GmbH, Westerstede, Germany, Practice for Hematology and Oncology, Langen, Germany, Department of Oncology and Hematology, Niels-Stensen-Kliniken, Georgsmarienhütte, Germany, Universitätsklinikum Schleswig-Holstein, Kiel, Germany, Med. Fakultät Mannheim der Universität Heidelberg, Mannheim, Germany, Practice for Hematology and Medical Oncology Velbert, Velbert, Germany, Universitätsklinikum Freiburg, Freiburg, Germany, University Hospital Rostock, Rostock, Germany, Universität Mainz, Klinik und Poliklinik für Geburtshilfe und Frauengesundheit, Mainz, Germany, InVO GbR, Koblenz, Germany, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany, Novartis Pharma GmbH, Nuernberg, Germany, University of Wuerzburg, Würzburg, Germany Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Background: RIBANNA is a real-world, noninterventional study conducted in Germany evaluating efficacy, safety, and tolerability of RIB in combination with AI/FUL aiming to gain insights into routine clinical practice for pts with HR+, HER2– ABC. Here, we present results of the fourth IA from RIBANNA. Methods: Pre-, peri- and postmenopausal pts who received 1L tx with RIB+AI/FUL, or ET or CT for HR+, HER2– ABC were included in accordance with the German tx guideline. The effect of baseline demographic characteristics, including histological grade, age, previous adjuvant tx, Eastern Cooperative Oncology Group-performance score (ECOG-PS), and metastatic sites on progression-free survival was evaluated using Cox regression model. Results: At data cutoff October 11, 2021, 2598 pts were enrolled in the study (RIB+AI/FUL, n = 2177; ET, n = 239; CT, n = 182). Data from 1L tx were available for 2492 pts (95.9%), second-line tx for 689 pts (26.5%), third-line tx for 263 pts (10.1%), and fourth-line tx for 94 pts (3.6%). Significant differences were observed in baseline mean age and metastatic sites for pts in RIB+AI/FUL cohort vs ET and CT cohorts (both < 0.001). At baseline, the mean (SD) ages of pts were 65.5 (11.6), 70.7 (11.5) and 61.6 (11.6) years in RIB+AI/FUL, ET, and CT cohorts, respectively. While comparing the performance status, 44.2% of pts in RIB+AI/FUL, 34.7% of pts in ET and 42.1% of pts in CT cohort were fully active with ECOG-PS = 0. CNS, liver, or lung metastases were recorded in 42.6% of pts in RIB+AI/FUL, 26.8% of pts in ET and 67.1% of pts in CT cohort. Bone only metastases were reported in 30.8%, 47.9% and 15.0% of pts in RIB+AI/FUL, ET, and CT cohorts, respectively. Overall, 32.1%, 37.7%, and 52.7% of pts discontinued the study in RIB+AI/FUL, ET, and CT cohorts, respectively, the most common reasons being deaths (16.1%,17.2%, and 31.9%, respectively) and lost to follow-up (5.9%, 8.8%, and 9.3%, respectively). The most common tx-emergent adverse event (grade 3 or 4) observed in RIB+AI/FUL cohort was neutropenia (14.8%), while 6.6% and 6.9% of pts in ET and CT cohorts, respectively, experienced neutropenia. The efficacy results from all 3 cohorts, including Kaplan-Meier curves, will be presented during ASCO 2022. Conclusions: RIBANNA study showed diverse population characteristics among pts who received RIB tx in a real-world setting. Overall higher number of pts were treated in 1L with RIB+AI/FUL followed by ET and CT. The differences in baseline characteristics on metastatic pattern, age, and ECOG-PS reflect different selection strategies for 1L tx decision. No new safety signals were identified. Clinical trial information: CLEE011ADE03.