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Proffered Paper - GU, non prostate 1

698O - Patient-reported outcomes (PROs) from IMvigor130: A global, randomised, partially blinded phase III study of atezolizumab (atezo) + platinum-based chemotherapy (PBC) vs placebo (PBO) + PBC in previously untreated locally advanced or metastatic urothelial carcinoma (mUC)

Date

19 Sep 2020

Session

Proffered Paper - GU, non prostate 1

Presenters

Aristotelis Bamias

Citation

Annals of Oncology (2020) 31 (suppl_4): S550-S550. 10.1016/annonc/annonc274

Authors

A. Bamias1, M. De Santis2, J.Á. Arranz3, E. Grande4, M.D. Galsky5, E. Kikuchi6, S.H. Park7, U. De Giorgi8, X. Garcia del Muro9, M. Mencinger10, B. Alekseev11, J. Puente12, K. Izumi13, M. Gumus14, B. Mellado Gonzalez15, J. Li16, C. Quach17, B. Ding18, S. Bernhard19, I.D. Davis20

Author affiliations

  • 1 2nd Propaedeutic Department Of Internal Medicine, National & Kapodistrian University of Athens, 12462 - Athens/GR
  • 2 Department Of Urology, Charité University Hospital, 10117 - Berlin/DE
  • 3 Department Of Medical Oncology, Gregorio Maranon Hospital, Madrid/ES
  • 4 Head Of Medical Oncology Department, MD Anderson Cancer Center Madrid, 28033 - Madrid/ES
  • 5 Tisch Cancer Institute, Mount Sinai Hospital, New York/US
  • 6 Department Of Urology, St. Marianna University School of Medicine, Kawasaki/JP
  • 7 Division Of Hematology-oncology, Department Of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 06351 - Seoul/KR
  • 8 Department Of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, 47014 - Meldola/IT
  • 9 Department Of Medical Oncology, Catalan Institute of Oncology, IDIBELL, University of Barcelona, 08908 - Barcelona/ES
  • 10 Department Of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana/SI
  • 11 Oncourology, Research Oncology Institute,, Tomsk/RU
  • 12 Department Of Medical Oncology, Medical Oncology Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), CIBERONC, 28040 - Madrid/ES
  • 13 Integrative Cancer Therapy And Urology, Kanazawa University Hospital, Kanazawa/JP
  • 14 Medical Oncology, Istanbul Medeniyet University, Istanbul/TR
  • 15 Department Of Medical Oncology, Hospital Clínic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona/ES
  • 16 Department Of Surgery, Taichung Veterans General Hospital, Taichung City/TW
  • 17 Patient-centered Outcomes Research, Genentech, South San Francisco/US
  • 18 Usma, Genentech, Inc., South San Francisco/US
  • 19 Product Development Oncology, F. Hoffmann-La Roche, Ltd., Welwyn/GB
  • 20 Eastern Health Clinical School, Monash University, Victoria/AU
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Resources

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Abstract 698O

Background

IMvigor130 met its co-primary endpoint of PFS (HR, 0.82 [95% CI: 0.70, 0.96]) for Arm A (atezo + PBC) vs C (PBO + PBC; Grande ESMO 2019; Galsky Lancet 2020). Atezo + PBC was well tolerated. Here we present PROs (Arm A vs C) to better evaluate the overall treatment (tx) benefit of adding atezo to PBC.

Methods

1213 eligible patients (pts) were randomized to Arm A, B (atezo monotherapy) or C. Atezo or PBO was given 1200 mg IV on day (D) 1 of each 3-wk tx cycle; PBC included gemcitabine 1000 mg/m2 IV on D1 and 8 + carboplatin AUC 4.5 or cisplatin 70 mg/m2 IV on D1. EORTC QLQ-C30 was completed q3w during tx, at tx discontinuation and ≈ q3 mo during survival follow-up. Descriptive analyses of scale scores (range, 0-100) included change from baseline (BL) summaries and time to deterioration (TTD) in all-comers in Arm A (n = 451) and C (n = 400).

Results

Completion rates were 86% at BL and > 70% until wk 66 in both arms; BL PRO scores were comparable. TTD was similar for most function/quality of life (QOL; Table) and symptom scales. HRs for symptom scales (nausea/vomiting, insomnia, appetite loss, diarrhoea, pain, constipation, fatigue, dyspnoea) ranged from 0.74 (95% CI: 0.57, 0.96; nausea/vomiting) to 1.16 (95% CI: 0.89, 1.51; dyspnoea). 12-mo deterioration-free rates favoured Arm A for nausea/vomiting, appetite loss, role function and social function. Change from BL summaries suggested similar changes (stable or marginal improvement) for both arms in most symptom, function and QOL domains through wk 51 (23% pts eligible for PRO assessments). Arm A pts sustained improved QOL above BL until wk 117 (wk 69 in Arm C). Table: 698O

IMvigor130 Arms A vs C TTD

Scale Stratified HR 95% CI
Role function 0.82 0.66, 1.02
QOL 0.87 0.68, 1.11
Social function 0.88 0.70, 1.10
Emotional function 0.95 0.70, 1.28
Cognitive function 0.97 0.76, 1.25
Physical function 1.05 0.84, 1.33

Stratification factors: PD-L1 status, Bajorin risk factors and/or liver metastases, investigator-specified PBC, enrolment stage. TTD refers to first ≥ 10-point score deterioration from BL.

Conclusions

Atezo + PBC improved PFS vs PBO + PBC without compromising pt function or QOL. Collectively, prolonged PFS, a satisfactory safety profile and these PROs reinforce atezo + PBC as an important new 1L mUC tx option.

Clinical trial identification

NCT02807636.

Editorial acknowledgement

Medical writing support for this abstract was provided by Madhubrata Ghosh, PhD, of Health Interactions, and funded by F. Hoffmann-La Roche, Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche, Ltd.

Funding

F. Hoffmann-La Roche, Ltd.

Disclosure

A. Bamias: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): BMS; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Honoraria (self): Debiopharm; Research grant/Funding (self): Pfizer; Research grant/Funding (self): Novartis; Research grant/Funding (institution): Pierre-Fabre; Research grant/Funding (institution): GSK. M. De Santis: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas Pharma; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer; Honoraria (self): Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pierre Fabre; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche/Genentech; Advisory/Consultancy: Amgen; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Basilea; Advisory/Consultancy: BioClin Therapeutics; Advisory/Consultancy: BioSyn Healthy Pharma Co; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy: Ferring; Advisory/Consultancy: GlaxoSmithKline; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Sandoz-Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: Synthon; Advisory/Consultancy: Takeda. J.Á. Arranz: Honoraria (self), Advisory/Consultancy: Astellas Pharma; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: EUSA Pharma; Honoraria (self), Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen-Cilag; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD Oncology; Honoraria (self): Roche Pharma AG; Honoraria (self): Sanofi; Advisory/Consultancy: Amgen; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bayer; Advisory/Consultancy: Eisai; Advisory/Consultancy: Merck; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Research grant/Funding (institution): Pierre Fabre; Travel/Accommodation/Expenses: Roche. E. Grande: Honoraria (self): Adacap; Honoraria (self): Astellas Pharma; Honoraria (self), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self): Celgene; Honoraria (self): Eisai; Honoraria (self): Eusa Pharma; Honoraria (self): Genzyme; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Ipsen; Honoraria (self), Travel/Accommodation/Expenses: Janssen-Cilag; Honoraria (self): Lexicon; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self): Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Honoraria (self): Pierre Fabre; Honoraria (self), Research grant/Funding (institution): Roche; Research grant/Funding (institution): Molecular Templates; Research grant/Funding (institution): AstraZeneca ; Travel/Accommodation/Expenses: Roche/Genentech. M.D. Galsky: Shareholder/Stockholder/Stock options: Rappta Therapeutics; Advisory/Consultancy: Aileron Therapeutics; Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: BioMotiv; Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Dendreon; Advisory/Consultancy: Dracen; Advisory/Consultancy: EMD Serono; Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Advisory/Consultancy: GlaxoSmithKline; Advisory/Consultancy: Incyte; Advisory/Consultancy: Inovio Pharmaceuticals; Advisory/Consultancy, Research grant/Funding (institution): Janssen; Advisory/Consultancy: Lilly; Advisory/Consultancy, Research grant/Funding (institution): Merck; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Seattle Genetics; Licensing/Royalties: Methods and compositions for treating cancer and related methods. Mount sinai school of medicine July 2012 Application number: 20120322792. E. Kikuchi: Honoraria (self), Research grant/Funding (institution): Astellas; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self): Bristol; Honoraria (self), Research grant/Funding (institution): Chugai; Honoraria (self): Fuso; Honoraria (self): Janssen; Research grant/Funding (institution): Kissei; Honoraria (self), Research grant/Funding (institution): Kyorin; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): Nippon Kayaku; Research grant/Funding (institution): Nippon Shinyaku; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Ono; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Taiho; Honoraria (self), Research grant/Funding (institution): Takeda. S.H. Park: Honoraria (self): Merck Sharp & Dohme; Honoraria (self): Sanofi/Aventis; Advisory/Consultancy: Janssen Oncology; Advisory/Consultancy: Lilly; Research grant/Funding (institution): Kura Oncology, Inc; Research grant/Funding (institution): Ono Pharmaceutical. U. De Giorgi: Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy: Bayer; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy: Merck; Advisory/Consultancy: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): AstraZeneca ; Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche. X. Garcia del Muro: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy: Eusa Pharma; Advisory/Consultancy, Speaker Bureau/Expert testimony: Ipsen; Advisory/Consultancy: Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: PharmaMar; Advisory/Consultancy: Roche; Research grant/Funding (institution): AstraZeneca. M. Mencinger: Honoraria (self): Roche; Honoraria (self): Swiss Pharma; Advisory/Consultancy: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Travel/Accommodation/Expenses: Astellas Pharma; Travel/Accommodation/Expenses: Pfizer. B. Alekseev: Speaker Bureau/Expert testimony: Astellas; Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Bayer; Speaker Bureau/Expert testimony: BMS; Speaker Bureau/Expert testimony: Eisai; Speaker Bureau/Expert testimony: Ferring; Speaker Bureau/Expert testimony: Janssen; Speaker Bureau/Expert testimony: Ipsen; Speaker Bureau/Expert testimony: MSD; Speaker Bureau/Expert testimony: Pfizer; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Sanofi. J. Puente: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Astellas Pharma; Honoraria (self): AstraZeneca; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Eisai; Honoraria (self): EUSA Pharma; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen-Cilag; Honoraria (self), Travel/Accommodation/Expenses: MSD Oncology; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Honoraria (self): Pierre Fabre; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy: Sanofi; Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy: Merck Sharp & Dohme. K. Izumi: Research grant/Funding (institution): Chugai Pharmaceutical. M. Gumus: Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (institution): Novartis; Honoraria (institution): BMS; Honoraria (institution): MSD; Honoraria (institution): Amgen; Honoraria (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: Gen İlac; Advisory/Consultancy: Astellas. B. Mellado Gonzalez: Speaker Bureau/Expert testimony, Research grant/Funding (institution): Astellas Pharma; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Bayer; Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Ipsen; Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Janssen; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Sanofi. J-R. Li: Honoraria (self): Amgen; Honoraria (self): Astellas Pharma; Honoraria (self): AstraZeneca; Honoraria (self): Bayer ; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Ipsen; Honoraria (self): Johnson & Johnson; Honoraria (self): MSD; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Pfizer; Honoraria (self): Roche. C. Quach: Shareholder/Stockholder/Stock options, Full/Part-time employment: Genentech. B. Ding: Shareholder/Stockholder/Stock options, Full/Part-time employment: Roche/Genentech. S. Bernhard: Full/Part-time employment: Roche. I.D. Davis: Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Astellas Pharma; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Janssen Oncology; Research grant/Funding (institution): MSD Oncology; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Roche/Genentech; Licensing/Royalties: International Patent Application No: PCT /US2004/032147 (NY-ESO-1) through Ludwig Institute for Cancer Research.

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