PROMS

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,7David 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

Presented on: ESMO, October 19-23, 2018, Munich, Germany

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

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 subpopulationHope S. Rugo,1 Johannes Ettl,2 Ruben G.W. Quek,3 Sara A. Hurvitz,4 Helen Bhattacharyya,5 Alison L. Hannah,2 Jennifer Keating Litton61

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

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

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

Numerical Trend Favored Ribociclib ArmFor Global HRQoL

Presented on: ESMO, October 19-23, 2018, Munich, Germany

MONALEESA 3

NR, not reached. aPatients censored at progression.

Global HRQoL Improved/Maintained Vs BaselineWhile On Treatment In Both Arms

Presented on: ESMO, October 19-23, 2018, Munich, Germany

MONALEESA 3

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.

HRQoL Worsened At EOT

Presented on: ESMO, October 19-23, 2018, Munich, Germany

MONALEESA 3

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.21. Slamon DJ et al. J Clin Oncol 2018;36:2465-2472;2. Osoba D et al. J Clin Oncol 1998;16:139-144.

Conclusions

Presented on: ESMO, October 19-23, 2018, Munich, Germany

• 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

MONALEESA 3

PRO, patient-reported outcomes.1. Slamon DJ et al. J Clin Oncol 2018;36:2465-2472.

TTD ≥10% In Global HRQoL Was DelayedWith Ribociclib Vs Placebo

Presented on: ESMO, October 19-23, 2018, Munich, Germany

MONALEESA 7

aPatients censored at progression; bSimilar results obtained with TTD ≥5%, ≥10%, and ≥15%.

Global HRQoL Improved/Maintained VsBaseline While On Treatment In Both Arms

Presented on: ESMO, October 19-23, 2018, Munich, Germany

MONALEESA 7

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.

Conclusions

Presented on: ESMO, October 19-23, 2018, Munich, Germany

• 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

MONALEESA 7

PRO, patient-reported outcomes.1. Tripathy D et al. Lancet Oncol 2018;19:904-915.

Time To Definitive Clinically Meaningful Deteriorationa

EORTC QLQ-C30 GHS/QoL (TNBC PRO Evaluable Subgroup)

Presented on: ESMO, October 19-23, 2018, Munich, Germany

aPost hoc subgroup analyses.

Conclusions

Presented on: ESMO, October 19-23, 2018, Munich, Germany

• 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 risk-benefit 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

EMBRACA

aHurvitz SA et al. Breast. 2018;41:S27-S28. bPost hoc subgroup anlyses.