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EFFECT OF ANTI-SPIKE NEUTRALIZING MONOCLONAL ANTIBODIES ON COVID-19 PROGRESSION AND TIME TO VIRAL CLEARANCE IN PATIENTS WITH HEMATOLOGICAL MALIGNANCIES AND SARS-COV-2 INFECTION: THE GIMEMA EXPERIENCE
Author(s): ,
Vincenzo Marasco
Affiliations:
Hematology and Bone Marrow Transplantation,Istituto Nazionale Dei Tumori di Milano,Milan,Italie;Hematology and Bone Marrow Transplantation,Istituto Nazionale Dei Tumori di Milano,Milan,Italien;Hematology and Bone Marrow Transplantation,Istituto Nazionale Dei Tumori di Milano,Milan,Italia;Hematology and Bone Marrow Transplantation,Istituto Nazionale Dei Tumori di Milano,Milan,Italy;Hematology and B
,
Anna Guidetti
Affiliations:
Hematology and Bone Marrow Transplantation,Istituto Nazionale Dei Tumori di Milano,Milan,Italie;Hematology and Bone Marrow Transplantation,Istituto Nazionale Dei Tumori di Milano,Milan,Italien;Hematology and Bone Marrow Transplantation,Istituto Nazionale Dei Tumori di Milano,Milan,Italia;Hematology and Bone Marrow Transplantation,Istituto Nazionale Dei Tumori di Milano,Milan,Italy;Hematology and B
,
Alfonso Piciocchi
Affiliations:
GIMEMA Foundation,Rome,Italie;GIMEMA Foundation,Rome,Italien;GIMEMA Foundation,Rome,Italia;GIMEMA Foundation,Rome,Italy;GIMEMA Foundation,Rome,Italia;GIMEMA Foundation,Rome,Italië;GIMEMA Foundation,Rome,Itália;GIMEMA Foundation,Rome,Италия;GIMEMA Foundation,Rome,Italien
,
Anna Candoni
Affiliations:
Dipartimento di Medicina Specialistica,University of Udine,Udine,Italie;Dipartimento di Medicina Specialistica,University of Udine,Udine,Italien;Dipartimento di Medicina Specialistica,University of Udine,Udine,Italia;Dipartimento di Medicina Specialistica,University of Udine,Udine,Italy;Dipartimento di Medicina Specialistica,University of Udine,Udine,Italia;Dipartimento di Medicina Specialistica,U
,
Monica Bocchia
Affiliations:
Hematology Unit,University of Siena, Azienda Ospedaliero Universitaria Senese,Siena,Italie;Hematology Unit,University of Siena, Azienda Ospedaliero Universitaria Senese,Siena,Italien;Hematology Unit,University of Siena, Azienda Ospedaliero Universitaria Senese,Siena,Italia;Hematology Unit,University of Siena, Azienda Ospedaliero Universitaria Senese,Siena,Italy;Hematology Unit,University of Siena,
,
Riccardo Bruna
Affiliations:
Division of Hematology, Department of Translational Medicine,University of Eastern Piedmont and Ospedale Maggiore della Carità,Novara,Italie;Division of Hematology, Department of Translational Medicine,University of Eastern Piedmont and Ospedale Maggiore della Carità,Novara,Italien;Division of Hematology, Department of Translational Medicine,University of Eastern Piedmont and Ospedale Maggiore del
,
Pellegrino Musto
Affiliations:
Department of Emergency and Organ Transplantation,"Aldo Moro" University School of Medicine and Unit of Hematology and Stem Cell Transplantation, AOU Consorziale Policlinico,Bari,Italie;Department of Emergency and Organ Transplantation,"Aldo Moro" University School of Medicine and Unit of Hematology and Stem Cell Transplantation, AOU Consorziale Policlinico,Bari,Italien;Department of Emergency and
,
Andrea Visentin
Affiliations:
Hematology and Clinical Immunology unit, Department of Medicine,University of Padova,Padova,Italie;Hematology and Clinical Immunology unit, Department of Medicine,University of Padova,Padova,Italien;Hematology and Clinical Immunology unit, Department of Medicine,University of Padova,Padova,Italia;Hematology and Clinical Immunology unit, Department of Medicine,University of Padova,Padova,Italy;Hema
,
Mauro Turrini
Affiliations:
Hematology,Ospedale Valduce,Napoli,Italie;Hematology,Ospedale Valduce,Napoli,Italien;Hematology,Ospedale Valduce,Napoli,Italia;Hematology,Ospedale Valduce,Napoli,Italy;Hematology,Ospedale Valduce,Napoli,Italia;Hematology,Ospedale Valduce,Napoli,Italië;Hematology,Ospedale Valduce,Napoli,Itália;Hematology,Ospedale Valduce,Napoli,Италия;Hematology,Ospedale Valduce,Napoli,Italien
,
Alessandra Tucci
Affiliations:
Department of Hematology,ASST Spedali Civili di Brescia,Brescia,Italie;Department of Hematology,ASST Spedali Civili di Brescia,Brescia,Italien;Department of Hematology,ASST Spedali Civili di Brescia,Brescia,Italia;Department of Hematology,ASST Spedali Civili di Brescia,Brescia,Italy;Department of Hematology,ASST Spedali Civili di Brescia,Brescia,Italia;Department of Hematology,ASST Spedali Civili
,
Carmine Selleri
Affiliations:
Hematology,Ospedale San Giovanni di Dio e Ruggi D'Aragona,Salerno,Italie;Hematology,Ospedale San Giovanni di Dio e Ruggi D'Aragona,Salerno,Italien;Hematology,Ospedale San Giovanni di Dio e Ruggi D'Aragona,Salerno,Italia;Hematology,Ospedale San Giovanni di Dio e Ruggi D'Aragona,Salerno,Italy;Hematology,Ospedale San Giovanni di Dio e Ruggi D'Aragona,Salerno,Italia;Hematology,Ospedale San Giovanni di
,
Enrico Crea
Affiliations:
GIMEMA Foundation,Rome,Italie;GIMEMA Foundation,Rome,Italien;GIMEMA Foundation,Rome,Italia;GIMEMA Foundation,Rome,Italy;GIMEMA Foundation,Rome,Italia;GIMEMA Foundation,Rome,Italië;GIMEMA Foundation,Rome,Itália;GIMEMA Foundation,Rome,Италия;GIMEMA Foundation,Rome,Italien
,
Paola Fazi
Affiliations:
GIMEMA Foundation,Rome,Italie;GIMEMA Foundation,Rome,Italien;GIMEMA Foundation,Rome,Italia;GIMEMA Foundation,Rome,Italy;GIMEMA Foundation,Rome,Italia;GIMEMA Foundation,Rome,Italië;GIMEMA Foundation,Rome,Itália;GIMEMA Foundation,Rome,Италия;GIMEMA Foundation,Rome,Italien
,
Francesco Passamonti
Affiliations:
Department of Medicine and Surgery,niversity of Insubria and ASST Sette Laghi, Ospedale di Circolo of Varese,Varese,Italie;Department of Medicine and Surgery,niversity of Insubria and ASST Sette Laghi, Ospedale di Circolo of Varese,Varese,Italien;Department of Medicine and Surgery,niversity of Insubria and ASST Sette Laghi, Ospedale di Circolo of Varese,Varese,Italia;Department of Medicine and Sur
Paolo Corradini
Affiliations:
Hematology and Bone Marrow Transplantation,Istituto Nazionale Dei Tumori di Milano,Milan,Italie;Hematology and Bone Marrow Transplantation,Istituto Nazionale Dei Tumori di Milano,Milan,Italien;Hematology and Bone Marrow Transplantation,Istituto Nazionale Dei Tumori di Milano,Milan,Italia;Hematology and Bone Marrow Transplantation,Istituto Nazionale Dei Tumori di Milano,Milan,Italy;Hematology and B
(Abstract release date: 05/12/22) EHA Library. Marasco V. 06/12/22; 357108; S244
Vincenzo Marasco
Vincenzo Marasco
Contributions
Abstract
Presentation during EHA2022: All Oral presentations will be presented between Friday, June 10 and Sunday, June 12 and will be accessible for on-demand viewing from Monday, June 20 until Monday, August 15, 2022 on the Congress platform.

Abstract: S244

Type: Oral Presentation

Session title: Immune response and infection in hematology - Clinical

Background

Patients with hematological malignancies (HM) infected with SARS-CoV-2 have a higher risk of developing severe coronavirus disease (COVID-19) with consequent death, due to immune system impairment. Anti-spike Neutralizing Monoclonal Antibodies (nMoAbs) are indicated for the treatment of paucisymptomatic COVID-19 patients, but evidence of safety and efficacy among HM subjects is still lacking.

Aims

To assess the efficacy of different nMoAbs approved by Agenzia Italiana del Farmaco (AIFA)  on HM patients affected by paucisymptomatic SARS-COV-2.

Methods
Multicenter retrospective observational study at ten sites in Italy, which enrolled consecutive patients with SARS-CoV-2 infection and treated with nMoAbs from February 2020 to December 2021. Only HM subjects on treatment or in disease remission within 6 months from treatment discontinuation with paucisymptomatic SARS-COV-2 infection were included. nMoAbs approved by AIFA include Bamlanivimab, Bamlanivimab/Etesevimab, Casirivimab/Imdevimab, Sotrovimab, and Regdanvimab. The primary endpoint was to assess the time to SARS-CoV-2 molecular swab negativization. A comparison  to an historical control not receiving nMoAbs was assessed. Secondary endpoints consisted in evaluation of hospitalization rate due to COVID-19, including intensive care unit (ICU) admission rate due to respiratory failure, and safety assessment.

Results
Overall 51 HM patients (median age 62 years; 35% women) were evaluated. Seventeen of them had non-Hodgkin lymphomas, 9 multiple myeloma, 6 chronic lymphocytic leukemia, 6 acute myeloid leukemia, 3 Hodgkin lymphoma, 2 acute lymphoblastic leukemia, 2 myeloproliferative neoplasm, 1 Waldenstrom macroglobulinemia and 5 had other HM diagnosis. Thirty-six patients were on active treatment, whereas 11 had completed their therapies within 6 months from nMoAbs administration, for 4 patients data were missing. In 7 subjects the last treatment was chemotherapy, in 19 immunotherapy with or without chemotherapy, in 9 target therapy, in 4 autologous stem cell transplantation, in 2 allogeneic stem cell transplantation, for 4 patients data were missing. Detailed description of patients’ characteristics is reported in table 1. Twenty-six patients were treated with Bamlanivimab/Etesevimab, 17 with Casirivimab/Imdevimab, 3 with Bamlanivimab, and 2 with Sotrovimab, for 3 patients data were missing. Median time to SARS-CoV-2 molecular swab negativization was evaluable in 41 subjects and was 17 days (min 5, IQR 12-26, max 174). This result compared well with the previous finding of 28 days  reported in an historical group of  HM patients not treated with nMoAbs. We did not find any subpopulation, according to age, diagnosis, period of infection or type of nMoAbs who achieved a major benefit from nMoAbs treatment. The rate of hospitalization due to COVID-19 progression was 19% (10/51), with an extremely low percentage of patients requiring ICU admission due to sever COVID-19 (2%,1/51). Most frequent side effects included chills (8%), diarrhea (6%), headache (2%), nausea (2%) and vomiting (2%).

Conclusion
Among paucisymptomatic  SARS-CoV-2 positive HM patients on active treatment or in disease remission within 6 months from  treatment discontinuation, the administration of nMoAbs substantially reduced the time to swab negativization compared to an historical control of HM subjects. This treatment was also able to reduce the rate of hospitalization and death due to COVID-19 progression in this high risk group.

Keyword(s): COVID-19, Hematological malignancy, Immunodeficiency, Monoclonal antibody

Presentation during EHA2022: All Oral presentations will be presented between Friday, June 10 and Sunday, June 12 and will be accessible for on-demand viewing from Monday, June 20 until Monday, August 15, 2022 on the Congress platform.

Abstract: S244

Type: Oral Presentation

Session title: Immune response and infection in hematology - Clinical

Background

Patients with hematological malignancies (HM) infected with SARS-CoV-2 have a higher risk of developing severe coronavirus disease (COVID-19) with consequent death, due to immune system impairment. Anti-spike Neutralizing Monoclonal Antibodies (nMoAbs) are indicated for the treatment of paucisymptomatic COVID-19 patients, but evidence of safety and efficacy among HM subjects is still lacking.

Aims

To assess the efficacy of different nMoAbs approved by Agenzia Italiana del Farmaco (AIFA)  on HM patients affected by paucisymptomatic SARS-COV-2.

Methods
Multicenter retrospective observational study at ten sites in Italy, which enrolled consecutive patients with SARS-CoV-2 infection and treated with nMoAbs from February 2020 to December 2021. Only HM subjects on treatment or in disease remission within 6 months from treatment discontinuation with paucisymptomatic SARS-COV-2 infection were included. nMoAbs approved by AIFA include Bamlanivimab, Bamlanivimab/Etesevimab, Casirivimab/Imdevimab, Sotrovimab, and Regdanvimab. The primary endpoint was to assess the time to SARS-CoV-2 molecular swab negativization. A comparison  to an historical control not receiving nMoAbs was assessed. Secondary endpoints consisted in evaluation of hospitalization rate due to COVID-19, including intensive care unit (ICU) admission rate due to respiratory failure, and safety assessment.

Results
Overall 51 HM patients (median age 62 years; 35% women) were evaluated. Seventeen of them had non-Hodgkin lymphomas, 9 multiple myeloma, 6 chronic lymphocytic leukemia, 6 acute myeloid leukemia, 3 Hodgkin lymphoma, 2 acute lymphoblastic leukemia, 2 myeloproliferative neoplasm, 1 Waldenstrom macroglobulinemia and 5 had other HM diagnosis. Thirty-six patients were on active treatment, whereas 11 had completed their therapies within 6 months from nMoAbs administration, for 4 patients data were missing. In 7 subjects the last treatment was chemotherapy, in 19 immunotherapy with or without chemotherapy, in 9 target therapy, in 4 autologous stem cell transplantation, in 2 allogeneic stem cell transplantation, for 4 patients data were missing. Detailed description of patients’ characteristics is reported in table 1. Twenty-six patients were treated with Bamlanivimab/Etesevimab, 17 with Casirivimab/Imdevimab, 3 with Bamlanivimab, and 2 with Sotrovimab, for 3 patients data were missing. Median time to SARS-CoV-2 molecular swab negativization was evaluable in 41 subjects and was 17 days (min 5, IQR 12-26, max 174). This result compared well with the previous finding of 28 days  reported in an historical group of  HM patients not treated with nMoAbs. We did not find any subpopulation, according to age, diagnosis, period of infection or type of nMoAbs who achieved a major benefit from nMoAbs treatment. The rate of hospitalization due to COVID-19 progression was 19% (10/51), with an extremely low percentage of patients requiring ICU admission due to sever COVID-19 (2%,1/51). Most frequent side effects included chills (8%), diarrhea (6%), headache (2%), nausea (2%) and vomiting (2%).

Conclusion
Among paucisymptomatic  SARS-CoV-2 positive HM patients on active treatment or in disease remission within 6 months from  treatment discontinuation, the administration of nMoAbs substantially reduced the time to swab negativization compared to an historical control of HM subjects. This treatment was also able to reduce the rate of hospitalization and death due to COVID-19 progression in this high risk group.

Keyword(s): COVID-19, Hematological malignancy, Immunodeficiency, Monoclonal antibody

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