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Safety and efficacy of atezolizumab (atezo) in patients (pts) with autoimmune disease (AID): subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma

Date

30 Sep 2019

Session

Poster Display session 3

Presenters

Yohann Loriot

Citation

Annals of Oncology (2019) 30 (suppl_5): v356-v402. 10.1093/annonc/mdz249

Authors

Y. Loriot1, C.N. Sternberg2, D. Castellano Gauna3, H. Dumez4, R. Huddart5, K.M. Vianna6, T. Alonso Gordoa7, I.A. Skoneczna8, A. Fay9, C.S.P. Sacco10, F. Nole11, F. Massari12, B. Brasiuniene13, P. Maroto14, S.F. Oosting15, S. Fear16, F. Di Nucci17, S. De Ducla18, E. Choy19

Author affiliations

  • 1 Department Of Cancer Medicine And Inserm U981, Université Paris-Sud, Université Paris-Saclay, Gustave Roussy, 94805 - Villejuif/FR
  • 2 Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy and Weill Cornell Medicine, 10021 - New York/US
  • 3 Medical Oncology Service, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
  • 4 General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, 3000 - Leuven/BE
  • 5 Oncology, Royal Marsden Hospital NHS Trust, Sutton/GB
  • 6 Clinical Oncology, CIONC, Curitiba/BR
  • 7 Medical Oncology, Hospital Ramon y Cajal, 28031 - Madrid/ES
  • 8 Medical Oncology, Szpital św. Elżbiety, Mokotowskie Centrum Medyczne, 02-781 - Warsaw/PL
  • 9 Oncoclínicas Group, PUCRS School of Medicine, Porto Alegre/BR
  • 10 Medical Oncology, A.O. Universitaria Santa Maria Della Misericordia di Udine, 33100 - Udine/IT
  • 11 Medical Division Of Urogenital And Head & Neck Cancer, European Institute of Oncology, 20141 - Milan/IT
  • 12 Division Of Oncology, Sant’Orsola-Malpighi Hospital, 40138 - Bologna/IT
  • 13 Department Of Medical Oncology, National Cancer Institute, 08406 - Vilnius/LT
  • 14 Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona/ES
  • 15 Department Of Medical Oncology, University Medical Center Groningen, University of Groningen, 9700 RB - Groningen/NL
  • 16 Product Development Medical Affairs Statistics, F Hoffmann-La Roche Ltd, Basel/CH
  • 17 Pd Safety Science, Genentech, Inc, South San Francisco/US
  • 18 Product Development Medical Affairs, F Hoffmann-La Roche Ltd, 4002 - Basel/CH
  • 19 Create Centre, Section Of Rheumatology, Division Of Infection And Immunity, Cardiff University School of Medicine, Cardiff/GB
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Background

Atezo, a monoclonal antibody targeting PD-L1, is an approved therapy for locally advanced/metastatic urothelial cancer. The pivotal IMvigor210 and IMvigor211 phase II and III trials excluded pts with significant pre-existing AID. The SAUL study (NCT02928406) in pts more representative of real-world practice showed median overall survival (OS) of 8.7 mo and safety consistent with previous atezo trials [Sternberg, Eur Urol 2019]. We analysed outcomes in pts with a history of AID.

Methods

Pts with locally advanced/metastatic urinary tract carcinoma, including pts ineligible for IMvigor211, received atezo 1200 mg q3w until loss of clinical benefit or unacceptable toxicity. The primary endpoint was safety, including adverse events of special interest (AESIs) for atezo as defined in the protocol. OS was a secondary endpoint. Subgroup analyses of AID pts were prespecified.

Results

Of 1004 pts enrolled from Nov 2016 to Mar 2018, 997 received atezo. In 35 pts presenting with AID, the most common pre-existing conditions were psoriasis (n = 15), thyroid AID (n = 5) and rheumatoid arthritis (n = 4). Compared with non-AID pts, AID pts had numerically more AESIs (46% vs 30%; grade ≥3 14% vs 6%) and treatment-related grade 3/4 AEs (26% vs 12%), but there were no relevant increases in treatment-related deaths (0% vs 1%) or AEs leading to atezo discontinuation (9% vs 6%). Pre-existing AID worsened in 6 pts: flares subsequently improved or resolved in 4 pts (without stopping atezo in 3 pts) but were unresolved in 2 pts (rash in 1 pt continuing atezo, psoriasis in 1 pt who discontinued atezo). In the 962 non-AID pts, new immune-related AEs were infrequent (6% hypothyroidism, 4% hyperthyroidism, 2% pneumonitis, 1% colitis). Efficacy was similar in AID vs non-AID pts (median OS 8.2 vs 8.8 mo, respectively; 1-year OS 31% vs 42%; disease control 51% vs 39%; median PFS 4.4 vs 2.2 mo).

Conclusions

In 35 atezo-treated pts with pre-existing AID, incidences of AESIs and treatment-related AEs appeared acceptable. AEs were manageable and rarely led to atezo discontinuation. Treating these pts requires caution but AID is not a barrier to atezo therapy per se.

Clinical trial identification

NCT02928406.

Editorial acknowledgement

Jennifer Kelly (Medi-Kelsey Ltd), funded by F Hoffmann-La Roche.

Legal entity responsible for the study

F Hoffmann-La Roche.

Funding

F Hoffmann-La Roche.

Disclosure

Y. Loriot: Honoraria (self), Honoraria (institution), Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Honoraria (institution), Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Honoraria (institution): Astellas; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: Janssen; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Honoraria (institution): BMS; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: Seattle Genetics; Honoraria (self), Honoraria (institution), Research grant / Funding (institution): Sanofi; Honoraria (self), Honoraria (institution): Clovis; Honoraria (institution): Incyte; Honoraria (self), Honoraria (institution): Pfizer; Licensing / Royalties, Pending patent (USA 62/455211, Europe 17209098.7): n/a. C.N. Sternberg: Advisory / Consultancy: MSD; Advisory / Consultancy: Clovis; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Incyte; Advisory / Consultancy: AstraZeneca; Research grant / Funding (institution): Janssen; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Pfizer. D. Castellano Gauna: Advisory / Consultancy: Bayer; Advisory / Consultancy: Roche; Advisory / Consultancy: Astellas; Advisory / Consultancy: Janssen; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD; Advisory / Consultancy: Merck Serono; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BMS; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Exelisis; Advisory / Consultancy: Lilly. H. Dumez: Advisory / Consultancy: Janssen; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Bayer; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: Jansen-Cilag; Travel / Accommodation / Expenses: Pfizer. R. Huddart: Honoraria (self), Travel / Accommodation / Expenses: Janssen; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Nektar; Research grant / Funding (institution): Cancer Research UK. K.M. Vianna: Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy: Novartis; Advisory / Consultancy: Bayer; Advisory / Consultancy: Pfizer; Speaker Bureau / Expert testimony: Roche; Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: BMS. T. Alonso Gordoa: Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony: IPSEN; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Speaker Bureau / Expert testimony: Janssen; Speaker Bureau / Expert testimony: Novartis. I.A. Skoneczna: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astellas; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Janssen; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self): Pfizer; Speaker Bureau / Expert testimony: IPSEN; Speaker Bureau / Expert testimony: BMS. A. Fay: Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self): Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Merck Sharp & Dohme. P. Maroto: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Novartis; Advisory / Consultancy: Janssen; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Bayer; Advisory / Consultancy: Bristol-Myers Squibb. S.F. Oosting: Research grant / Funding (institution): Celldex; Research grant / Funding (institution): Novartis. S. Fear: Full / Part-time employment: F. Hoffmann-La Roche. F. Di Nucci: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/ Genentech. S. De Ducla: Shareholder / Stockholder / Stock options, Full / Part-time employment: F. Hoffmann-La Roche. E. Choy: Honoraria (self): AbbVie; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Honoraria (self): ObsEva; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pfizer; Honoraria (self): Merck Serono; Honoraria (self), Speaker Bureau / Expert testimony: Regeneron; Honoraria (self), Advisory / Consultancy: Roche/Genentech; Honoraria (self): R-Pharm; Honoraria (self): SynAct Pharma; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Sanofi; Advisory / Consultancy: Sanofi/Regeneron; Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Speaker Bureau / Expert testimony: Janssen; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Speaker Bureau / Expert testimony: UCB; Research grant / Funding (institution): Bio-Cancer Treatment International; Research grant / Funding (institution): Biogen. All other authors have declared no conflicts of interest.

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