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Proffered Paper session

1O - Clinical outcomes in post-operative ctDNA-positive muscle-invasive urothelial carcinoma (MIUC) patients after atezolizumab adjuvant therapy


10 Dec 2020


Proffered Paper session


Thomas Powles


Annals of Oncology (2020) 31 (suppl_7): S1417-S1424. 10.1016/annonc/annonc389


T. Powles1, Z.J. Assaf2, N. Davarpanah2, M. Hussain3, S. Oudard4

Author affiliations

  • 1 Bart's Cancer Institute, London/GB
  • 2 Genentech, Inc., South San Francisco/US
  • 3 Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago/US
  • 4 Georges Pompidou European Hospital, University of Paris, Paris/FR


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Abstract 1O


MIUC carries a substantial risk for death; nearly 50% of patients (pts) develop recurrence within 2 years of cystectomy. IMvigor010, a global phase III trial, evaluated adjuvant treatment with atezolizumab (atezo) (anti-PD-L1) compared with observation (obs) in MIUC. Circulating tumor DNA (ctDNA) has been shown across multiple indications to be a strong predictor of recurrence. A ctDNA exploratory analysis was included prospectively to evaluate if: 1) atezo provides clinical benefit vs obs in pts with detectable ctDNA (ctDNA+) and 2) ctDNA clearance occurs at a higher rate with atezo vs obs.


Biomarker evaluable pts (BEP) had evaluable tissue whole exome sequencing (WES) and C1D1 plasma (median 11 weeks post-cystectomy) for ctDNA analysis by Natera’s Signatera assay (n=581; 72% of intent to treat population [ITT]). Baseline characteristics were similar between ITT and BEP. Tumor mutational burden (TMB) status and PD-L1 status were determined by WES and Ventana SP142 antibody.


Prevalence of ctDNA+ was 37% (n=214); positivity was associated with nodal status (p<0.001) and to a lesser extent tumor stage (p=0.09) but no other baseline factors. While IMvigor010 did not meet its primary endpoint of disease free survival (DFS) in the ITT, ctDNA+ pts showed substantial DFS benefit with atezo vs obs (HR=0.58 [95% CI 0.43 – 0.79]; p=0.0005). Interim analysis of overall survival (OS) also favored atezo in ctDNA+ pts (HR=0.59 [95% CI 0.41 – 0.86]; p=0.0059), with median OS 25.8 months with atezo vs 15.8 with obs. No benefit was noted for ctDNA→ pts. Within the ctDNA+ pts, additional survival benefit was derived for PD-L1-high pts (HR=0.52 [95% CI 0.331-0.82]; p=0.004), and TMB-high pts (HR=0.34 [95% CI 0.19-0.6]; p<0.0001]). The rate of ctDNA clearance from C1D1 to C3D1 was higher in atezo (18.2%) vs obs (3.8%) (p=0.0048).


Post-surgical ctDNA positivity, associated with high risk for recurrence and death, identified MIUC patients likely to benefit from adjuvant atezo. Detection of minimal residual disease in an adjuvant setting will allow personalized treatment selection for patients.

Clinical trial identification


Editorial acknowledgement

Medical writing assistance for this abstract was provided by Harbeen Grewal of Anshin BioSolutions Corp. and funded by F. Hoffmann-La Roche, Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche, Ltd.


F. Hoffmann-La Roche, Ltd.


T.B. Powles: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy, Research grant/Funding (institution): Exelixis; Advisory/Consultancy: Incyte; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Research grant/Funding (institution): Merck; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution): Seattle Genetics; Advisory/Consultancy, Research grant/Funding (institution): Merck Serono (EMD Serono); Advisory/Consultancy, Research grant/Funding (institution): Astellas; Advisory/Consultancy, Research grant/Funding (institution): Johnson & Johnson; Advisory/Consultancy: Eisai; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche. Z.J. Assaf: Full/Part-time employment: Genentech; Full/Part-time employment, Previous Employment: Natera. N. Davarpanah: Full/Part-time employment: Genentech; Shareholder/Stockholder/Stock options: Roche. M. Hussain: Honoraria (self), Research grant/Funding (self), Research grant/Funding (institution), Honorarium for an educational lecture to Singapore GU Oncology Physicians: AstraZeneca; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Bayer; Advisory/Consultancy, Research grant/Funding (self): Genentech; Honoraria (self), Travel/Accommodation/Expenses: Astellas Pharma; Travel/Accommodation/Expenses: Genentech/Roche; Honoraria (self): Physicians' Education Resource; Honoraria (self), Served as a contributing faculty on a written educational chapter: Projects in Knowledge; Honoraria (self): Sanofi/Genzyme; Honoraria (self): Research to Practice; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Daiichi Sankyo; Licensing/Royalties: Systems and Methods For Tissue Imaging; Licensing/Royalties: Method of Treating Cancer; Licensing/Royalties: Dual Inhibition of MET and VEGF for the Treatment of Castration Resistant Prostate Cancer and Osteoblastic Bone Metastases. S. Oudard: Honoraria (self), Advisory/Consultancy: Astellas; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Eisai; Research grant/Funding (self): Ipsen; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Sanofi. J.E. Gschwend: Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: Janssen-Cilag; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Roche; Advisory/Consultancy: Bristol Myers Squibb. P. Albers: Honoraria (self), Advisory/Consultancy: MSD Oncology; Honoraria (self): Sanofi; Advisory/Consultancy: Roche/Genentech. D. Castellano: Advisory/Consultancy, Research grant/Funding (institution): Janssen Oncology; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche/Genentech; Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: Novartis; Advisory/Consultancy: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Bayer; Advisory/Consultancy: Lilly; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Boehringer Ingelheim; Travel/Accommodation/Expenses: AstraZeneca Spain. H. Nishiyama: Advisory/Consultancy: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Chugai Pharma; Advisory/Consultancy: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Astellas Pharma; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy: Bristol Myers Squibb; Research grant/Funding (institution): Ono Pharmaceutical. S. Daneshmand: Honoraria (self), Advisory/Consultancy: Ferring; Honoraria (self): MDxHealth; Honoraria (self): Olympus; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Photocure; Honoraria (self), Advisory/Consultancy: QED Therapeutics; Honoraria (self): Spectrum Pharmaceuticals; Honoraria (self): Pacific Edge; Advisory/Consultancy: Taris. P. Grivas: Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Research grant/Funding (institution), Non-remunerated activity/ies, Participation in educational program: Bristol Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Clovis Oncology; Advisory/Consultancy: Driver; Advisory/Consultancy: EMD Serono; Advisory/Consultancy: Exelixis; Advisory/Consultancy: Foundation Medicine; Advisory/Consultancy, Research grant/Funding (institution): GlaxoSmithKline; Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Advisory/Consultancy: Genzyme; Advisory/Consultancy: Heron Therapeutics; Advisory/Consultancy: Janssen; Advisory/Consultancy, Research grant/Funding (institution): Merck; Mirati Therapeutics; Pfizer; QED Therapeutics; Research grant/Funding (institution): Immunomedics; Research grant/Funding (institution): Kure It Cancer Research; Research grant/Funding (institution): Debiopharm; Advisory/Consultancy: Seattle Genetics; Research grant/Funding (institution): Oncogenex; Research grant/Funding (institution): Bavarian Nordic. S. Sharma: Full/Part-time employment: Natera. H. Sethi: Full/Part-time employment: Natera. A. Aleshin: Full/Part-time employment: Natera. J. Zhang: Full/Part-time employment: Hoffmann-La Roche Ltd. V. Degaonkar: Full/Part-time employment: Genentech; Shareholder/Stockholder/Stock options: Roche. C. Bais: Full/Part-time employment: Genentech. C.A. Carter: Full/Part-time employment: Genentech. J. Bellmunt: Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy: AstraZeneca/MedImmune; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Genentech; Advisory/Consultancy: Merck; Advisory/Consultancy: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: Pierre Fabre; Research grant/Funding (institution): Millennium; Research grant/Funding (institution): Sanofi; Travel/Accommodation/Expenses: MSD Oncology; Honoraria (self): UpToDate; Shareholder/Stockholder/Stock options: Rainier; Research grant/Funding (institution): Pfizer/EMD Serono; Travel/Accommodation/Expenses: Ipsen. S. Mariathasan: Full/Part-time employment: Genentech.

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