Patient-reported outcomes in advanced breast cancer treated with Ribociclib + Fulvestrant: results from MONALEESA-3

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1 PROMS Patient-reported outcomes in advanced breast cancer treated with Ribociclib + Fulvestrant: results from MONALEESA-3 Peter A. Fasching,1 Francisco J. Esteva,2 Xavier Pivot,3 Arnd Nusch,4 J. Thaddeus Beck,5 Arlene Chan,6 Asanthi Pieris Gunatilaka,7 Yingbo Wang,8 Brad Lanoue,7 David Chandiwana,7 Patrick Neven9 1University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany; 2NYU Langone Health, New York, NY, USA; 3Institut Régional du Cancer, Strasbourg, France; 4Practice for Haematology and Internal Oncology, Velbert, Germany; 5Highlands Oncology Group, Fayetteville, AR, USA; 6Breast Cancer Research Centre WA, Nedlands, Australia; 7Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 8Novartis Pharma AG, Basel, Switzerland; 9Multidisciplinary Breast Centre, Universitair Ziekenhuis Leuven, Leuven, Belgium Ribociclib + Tamoxifen or a non-steroidal aromatase inhibitor in premenopausal patients with hormone receptor-positive, HER2-negative advanced breast cancer: MONALEESA-7 patient-reported outcomes Nadia Harbeck,1 Rafael Villanueva Vázquez,2 Fábio Franke,3 Govind Babu,4 Paul Wheatley-Price,5 Young-Hyuck Im,6 Kadri Altundag,7 Brad Lanoue,8 Jahangir Alam,8 David Chandiwana,8 Marco Colleoni9 1Breast Center, Department of Gynecology and Obstetrics, University of Munich (LMU), Munich, Germany; 2Institut Català d Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain; 3Hospital de Caridade de Ijuí, CACON, Ijuí, Brasil; 4HCG Curie Centre of Oncology and Kidwai Memorial Institute of Oncology, Bangalore, India; 5University of Ottawa, Ottawa, ON, Canada; 6Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 7Department of Medical Oncology, Hacettepe University Faculty of Medicine, Ankara, Turkey; 8Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 9Division of Medical Senology Istituto Europeo di Oncologia, Milan, Italy Patient-reported outcomes in patients with advanced breast cancer and a germline BRCA1/2 mutation receiving Talazoparib vs physician s choice chemotherapy treatment: A focus on the EMBRACA triple-negative subpopulation Hope S. Rugo,1 Johannes Ettl,2 Ruben G.W. Quek,3 Sara A. Hurvitz,4 Helen Bhattacharyya,5 Alison L. Hannah,2 Jennifer Keating Litton6 1 UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA; 2Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technische Universität München, München, Germany; 3Pfizer Inc., San Francisco, CA, USA; 4University of California, Los Angeles, Los Angeles, CA, USA; 5Pfizer Inc., New York, NY, USA; 6The University of Texas MD Anderson Cancer Center, Houston, TX, USA

2 Numerical Trend Favored Ribociclib Arm For Global HRQoL NR, not reached. apatients censored at progression. MONALEESA 3

S, screening; SEM, standard error of the mean.

3 Global HRQoL Improved/Maintained Vs Baseline While On Treatment In Both Arms C, cycle; D, day; LS, least squares; S, screening; SEM, standard error of the mean. aeot assessment occurred within 15 days from last dose of study drug. MONALEESA 3

HRQoL Worsened At EOT Analysis only includes patients with EOT assessments (occured within 15 days from last dose of study drug). p-value based on paired t-test.

4 HRQoL Worsened At EOT Analysis only includes patients with EOT assessments (occured within 15 days from last dose of study drug). p-value based on paired t-test. >5-point change in HRQoL score considered clinically meaningful.2 1. Slamon DJ et al. J Clin Oncol 2018;36: ;2. Osoba D et al. J Clin Oncol 1998;16: MONALEESA 3

5 Conclusions Ribociclib + fulvestrant significantly prolonged PFS vs placebo + fulvestrant in postmenopausal women with HR+, HER2- ABC1 PRO data from MONALEESA-3 show that ribociclib + fulvestrant maintains HRQoL - Numerical trend favored ribociclib vs placebo for TTD 10% in global HRQoL - Global HRQoL was improved/maintained vs baseline while on treatment, but worsened when treatment was stopped in both arms Supports the importance of delaying disease progression to maintain patients quality of life Delayed disease progression experienced with ribociclib is associated with maintained HRQoL - AEs associated with ribociclib do not substantially impact HRQoL PRO, patient-reported outcomes. 1. Slamon DJ et al. J Clin Oncol 2018;36: MONALEESA 3

6 TTD 10% In Global HRQoL Was Delayed With Ribociclib Vs Placebo apatients censored at progression; bsimilar results obtained with TTD 5%, 10%, and 15%. MONALEESA 7

7 Global HRQoL Improved/Maintained Vs Baseline While On Treatment In Both Arms C, cycle; D, day; LS, least squares; S, screening; SEM, standard error of the mean. aeot assessment occurred within 15 days from last dose of study drug. MONALEESA 7

8 Conclusions In MONALEESA-7, ribociclib + ET significantly prolonged PFS vs placebo + ET in premenopausal women with HR+, HER2- ABC1 PRO data reveal that ribociclib + ET maintains or improves HRQoL in this setting - Ribociclib + ET delayed TTD 10% in global HRQoL compared with placebo + ET - Pain and fatigue were improved or maintained with ribociclib + ET vs placebo + ET during treatment - Diarrhea and nausea/vomiting were rare with ribociclib and did not negatively impact HRQoL - Activity and work productivity were similar between the ribociclib and placebo arms Activity and work productivity are important considerations for premenopausal patients Delayed disease progression experienced with ribociclib is associated with improved/maintained HRQoL - AEs associated with ribociclib do not substantially impact HRQoL PRO, patient-reported outcomes. 1. Tripathy D et al. Lancet Oncol 2018;19: MONALEESA 7

9 Time To Definitive Clinically Meaningful Deteriorationa EORTC QLQ-C30 GHS/QoL (TNBC PRO Evaluable Subgroup) apost hoc subgroup analyses.

10 Conclusions As part of this post hoc subgroup analysis of EMBRACA patients with locally advanced/metastatic TNBC and gbrca mutation, significant overall differences favouring talazoparib were observed in the patient-reported: - GHS/QoL - Functions: physical, role, social functioning, and body image - Symptoms: fatigue, pain, appetite loss, and breast and arm symptoms A significant delay in time to definitive clinically meaningful deterioration was observed in patient-reported: - GHS/QoL - Functions: physical, role, emotional, cognitive, social functioning, and body image - Symptoms: fatigue, pain, insomnia, appetite loss, systemic therapy side effects, and arm symptoms Notably, when comparing arms, none of the analyses yielded statistically significant PRO results favouring PCT Similar findings were seen in the HR+/HER2- population8 Among patients with locally advanced/metastatic TNBC and gbrca mutation, these PRO results further support the positive riskbenefit profile of talazoparib On October 16, 2018, the US Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.) for adult patients with deleterious or suspected deleterious germline BRCA-mutated, HER2 negative locally advanced or metastatic breast cancer9 The European Medicines Agency has accepted regulatory submission for review of talazoparib10 ahurvitz SA et al. Breast. 2018;41:S27-S28. bpost hoc subgroup anlyses. EMBRACA

290O - Patient-reported outcomes (PROs) in advanced breast cancer (ABC) treated with ribociclib + fulvestrant: results from MONALEESA-3

290O - Patient-reported outcomes (PROs) in advanced breast cancer (ABC) treated with ribociclib + fulvestrant: results from MONALEESA-3 Presentation Number: 290O Lecture Time: 11:18-11:33 Speakers: Peter