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

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.