Induction of natural killer antibody-dependent cell cytotoxicity and of clinical activity of cetuximab plus avelumab in non-small cell lung cancer.


Journal

ESMO open
ISSN: 2059-7029
Titre abrégé: ESMO Open
Pays: England
ID NLM: 101690685

Informations de publication

Date de publication:
09 2020
Historique:
received: 18 03 2020
revised: 25 05 2020
accepted: 28 05 2020
entrez: 11 9 2020
pubmed: 12 9 2020
medline: 19 8 2021
Statut: ppublish

Résumé

Antibody-dependent cell-mediated cytotoxicity (ADCC) may mediate antitumour activity of IgG1-isotype monoclonal antibody (mAb), suggesting as potential treatment combination of IgG1-mAbs, anti-epidermal growth factor receptor cetuximab and anti-programmed death-ligand-1 avelumab. We evaluated ADCC induction in lung cancer cells by lactate dehydrogenase (LDH) release assay. Antitumour activity and safety of cetuximab plus avelumab were explored in a single-arm proof-of-concept study in pre-treated non-small cell lung cancer (NSCLC) patients (pt) (Cetuximab-AVElumab-lung, CAVE-Lung). Search for predictive biomarkers of response was done. Avelumab plus cetuximab induced ADCC in NSCLC cells in vitro in presence of natural killers (NK) from healthy donors (HD) or NSCLC pt, as effectors. Sixteen relapsed NSCLC pt were treated with avelumab plus cetuximab. Antitumour activity was observed in 6/16 pt, defined by progression free survival (PFS) ≥8 months, with 4 of them still on treatment at data lock time (range, 14-19 months). Of note, 3/6 responders had received as previous line anti-programmed death-1 therapy. In responders, clinical benefit was accompanied by significant increase in LDH release over baseline at the first radiological evaluation (8 weeks) (p=0.01) and by early skin toxicity; while in the 10 non-responders, that had PFS ≤5 months, LDH release tends to reduce. Baseline circulating DNA levels were higher in non-responders compared with responders and HD (p=0.026) and decrease in responders during therapy. Mutations in DNA damage responsive family genes were found in responders. Cetuximab and avelumab activates NSCLC pt NK cells. Ex vivo evaluation of ADCC, circulating DNA levels and early skin toxicity may predict response to cetuximab plus avelumab in NSCLC.EUDRACT 2017-004195-58.

Sections du résumé

BACKGROUND
Antibody-dependent cell-mediated cytotoxicity (ADCC) may mediate antitumour activity of IgG1-isotype monoclonal antibody (mAb), suggesting as potential treatment combination of IgG1-mAbs, anti-epidermal growth factor receptor cetuximab and anti-programmed death-ligand-1 avelumab.
METHODS
We evaluated ADCC induction in lung cancer cells by lactate dehydrogenase (LDH) release assay. Antitumour activity and safety of cetuximab plus avelumab were explored in a single-arm proof-of-concept study in pre-treated non-small cell lung cancer (NSCLC) patients (pt) (Cetuximab-AVElumab-lung, CAVE-Lung). Search for predictive biomarkers of response was done.
RESULTS
Avelumab plus cetuximab induced ADCC in NSCLC cells in vitro in presence of natural killers (NK) from healthy donors (HD) or NSCLC pt, as effectors. Sixteen relapsed NSCLC pt were treated with avelumab plus cetuximab. Antitumour activity was observed in 6/16 pt, defined by progression free survival (PFS) ≥8 months, with 4 of them still on treatment at data lock time (range, 14-19 months). Of note, 3/6 responders had received as previous line anti-programmed death-1 therapy. In responders, clinical benefit was accompanied by significant increase in LDH release over baseline at the first radiological evaluation (8 weeks) (p=0.01) and by early skin toxicity; while in the 10 non-responders, that had PFS ≤5 months, LDH release tends to reduce. Baseline circulating DNA levels were higher in non-responders compared with responders and HD (p=0.026) and decrease in responders during therapy. Mutations in DNA damage responsive family genes were found in responders.
CONCLUSION
Cetuximab and avelumab activates NSCLC pt NK cells. Ex vivo evaluation of ADCC, circulating DNA levels and early skin toxicity may predict response to cetuximab plus avelumab in NSCLC.EUDRACT 2017-004195-58.

Identifiants

pubmed: 32912860
pii: S2059-7029(20)32693-4
doi: 10.1136/esmoopen-2020-000753
pmc: PMC7484864
pii:
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Immunoglobulin G 0
avelumab KXG2PJ551I
Cetuximab PQX0D8J21J

Banques de données

EudraCT
['2017-004195-58']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e000753

Informations de copyright

© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.

Déclaration de conflit d'intérêts

Competing interests: MF: family relation with Merck; AM: Consultancy and Advisory Boards: Roche, AstraZeneca, Boehringer, Pfizer, Takeda, BMS, MSD; EM: Consultancy and Advisory Boards: Eli Lilly, Sanofi, Cellgene, Servier; FC: Advisory Boards: Roche, Amgen, Merck, Pfizer, Sanofi, Bayer, Servier, BMS, Cellgene, Lilly; Institutional Research Grants: Bayer, Roche, Merck, Amgen, AstraZeneca, Ipsen; FM: Advisory Boards MSD, Lilly; Institutional Research Grants: AstraZeneca.

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Auteurs

Morena Fasano (M)

Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Napoli, Campania, Italy.

Carminia Maria Della Corte (CM)

Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Napoli, Campania, Italy.

Raimondo Di Liello (R)

Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Napoli, Campania, Italy.

Giusi Barra (G)

Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Napoli, Campania, Italy.

Francesca Sparano (F)

Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Napoli, Campania, Italy.

Giuseppe Viscardi (G)

Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Napoli, Campania, Italy.

Maria Lucia Iacovino (ML)

Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Napoli, Campania, Italy.

Fernando Paragliola (F)

Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Napoli, Campania, Italy.

Vincenzo Famiglietti (V)

Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Napoli, Campania, Italy.

Vincenza Ciaramella (V)

Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Napoli, Campania, Italy.

Flora Cimmino (F)

Department of Molecular Medicine and Biotechnologies, CEINGE Advanced Biotechnologies, Napoli, Campania, Italy.

Mario Capasso (M)

Department of Molecular Medicine and Biotechnologies, CEINGE Advanced Biotechnologies, Napoli, Campania, Italy.

Achille Iolascon (A)

Department of Molecular Medicine and Biotechnologies, CEINGE Advanced Biotechnologies, Napoli, Campania, Italy.

Vincenzo Sforza (V)

Department of Thoracic Oncology, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.

Alessandro Morabito (A)

Department of Thoracic Oncology, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.

Evaristo Maiello (E)

Medical Oncology and Immunotherapy Division, Istituto Toscano Tumori, Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

Fortunato Ciardiello (F)

Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Napoli, Campania, Italy.

Floriana Morgillo (F)

Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Napoli, Campania, Italy. Electronic address: floriana.morgillo@unicampania.it.

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Classifications MeSH