Exposure to obinutuzumab does not affect outcomes of SARSCoV‐2 infection in vaccinated patients with newly diagnosed advanced‐stage follicular lymphoma

Author:

Pinto A.1ORCID,Caltagirone M.2,Battista M.3,Gazzoli G. C.4,Patti C.5,Pennese E.6,De Lorenzo S.7,Pavone V.8,Merli M.9ORCID,Chiarenza A.10,Gorgone A. G.11,Piazza F.12,Puccini B.13,Noto A.9,Arcaini L.1415ORCID,De Filippi R.16,Zinzani P. L.1718ORCID,Ferreri A. J. M.19,Ladetto M.20,Ferrari S.21,Gritti G.21

Affiliation:

1. Ematologia Oncologica Istituto Nazionale Tumori, Fondazione ‘G. Pascale’, IRCCS Naples Italy

2. Medical Affairs Roche S.p.A. Monza Italy

3. Clinical Operations Roche S.p.A. Monza Italy

4. International Patient Safety, Roche S.p.A. Monza Italy

5. Ospedali Riuniti Villa Sofia – Cervello Palermo Italy

6. Unità Operativa Complessa Ematologia Presidio Ospedaliero Pescara Pescara Italy

7. U.O.C. “Ematologia e TMO” AORN “S. G. Moscati” Avellino Italy

8. Unità Operativa Complessa di Ematologia e Trapianto di Cellule Staminali Emopoietiche, Azienda Ospedaliera Cardinale Panico Tricase Italy

9. Hematology Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Milan Italy

10. U.O.C. Ematologia Con TMO, Azienda Ospedaliero Universitaria Policlinico “G. Rodolico – San Marco” Catania Italy

11. UOC Ematologia ARNAS Garibaldi Catania Italy

12. UOC Ematologia, Azienda Ospedaliero‐Universitaria di Padova, University of Padova Padova Italy

13. Ematologia Azienda Ospedaliero‐Universitaria Careggi Florence Italy

14. Department of Molecular Medicine University of Pavia Pavia Italy

15. Division of Hematology, Fondazione IRCCS Policlinico San Matteo di Pavia University of Pavia Pavia Italy

16. Dipartimento di Medicina Clinica e Chirurgia Scuola di Medicina, Università Federico II Naples Italy

17. IRCCS Azienda Ospedaliero‐Universitaria di Bologna, Istituto di Ematologia “Seràgnoli” Bologna Italy

18. Dipartimento di Scienze Mediche e Chirurgiche Università di Bologna Bologna Italy

19. Lymphoma Unit IRCCS San Raffaele Scientific Institute and University Vita‐Salute San Raffaele Milan Italy

20. Dipartimento di Medicina Traslazionale Università del Piemonte Orientale SCDU Ematologia, AOU SS Antonio e Biagio e Cesare Arrigo Alessandria Italy

21. UOC Ematologia Ospedale Papa Giovanni XXIII Bergamo Italy

Abstract

SummaryURBAN is a multicentric, ambispective study evaluating the effectiveness and safety of obinutuzumab‐based immuno‐chemotherapy and maintenance in patients with untreated advanced follicular lymphoma (FL). The study began before the COVID‐19 emergency declaration in Italy. It is currently ongoing for follow‐up, and the enrolment timeline encompassed different stages of the pandemic, various vaccination roll‐out phases and prevalence of SARS‐CoV‐2 variants. Outcomes of interest of the present sub‐analysis included SARS‐CoV‐2 infection rates and COVID‐19‐related hospitalizations/deaths. At data cut‐off, 86 (28.8%) and 213 patients (71.2%) were treated before and during/after the COVID‐19 outbreak respectively; 294 (98.3%) completed the induction, 31 (10.4%) completed maintenance and 170 (56.9%) were still on maintenance. Overall, 245 patients (81.9%) received at least one SARS‐CoV‐2 vaccine dose: 13.5%, 31.4% and 55.1% received one, two and three doses respectively. We observed a substantial decrease in COVID‐19‐related mortality rates in pre‐ versus post‐vaccination phases, along with a reduction in COVID‐19‐related outcomes due to the shift from alpha/delta to omicron variant predominance. No differences emerged between patients given maintenance or not, although the schedule was modified in 65% of cases. To our knowledge, URBAN represents the largest dataset of COVID‐19‐related outcomes in FL patients extensively exposed to obinutuzumab. ClinicalTrials.gov identifier: NCT04034056.

Funder

Roche

Publisher

Wiley

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