dc.contributor
Institut Català de la Salut
dc.contributor
[Verlingue L] Gustave Roussy Institute of Oncology, Villejuif, France. [Italiano A] Institut Bergonié Cancer Center, Bordeaux, France. [Prenen H] Antwerp University Hospital, Edegem, Belgium. [Guerra Alia EM] Ramón y Cajal University Hospital, Madrid, Spain. [Tosi D] Montpellier Cancer Institute, Montpellier, France. [Perets R] Division of Oncology, Clinical Research Institute at Rambam, Rambam Medical Center, Haifa, Israel. [Oaknin A] Gynaecologic Cancer Programme, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Verlingue, Loic
dc.contributor.author
Prenen, Hans
dc.contributor.author
Guerra Alia, Eva Maria
dc.contributor.author
Tosi, Diego
dc.contributor.author
ITALIANO, ANTOINE
dc.contributor.author
Perets, Ruth
dc.contributor.author
OAKNIN, ANA
dc.date.issued
2024-11-26T13:51:49Z
dc.date.issued
2024-11-26T13:51:49Z
dc.identifier
Verlingue L, Italiano A, Prenen H, Guerra Alia EM, Tosi D, Perets R, et al. Phase 2 study of the antitumour activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in patients with recurrent and/or metastatic cervical squamous cell carcinoma. eBioMedicine. 2024 Nov;109:105374.
dc.identifier
https://hdl.handle.net/11351/12281
dc.identifier
10.1016/j.ebiom.2024.105374
dc.identifier
001342392900001
dc.description.abstract
Cervical cancer; Immunotherapy; Squamous cell carcinoma
dc.description.abstract
Cáncer de cuello uterino; Inmunoterapia; Carcinoma de células escamosas
dc.description.abstract
Càncer de coll uterí; Immunoteràpia; Carcinoma de cèl·lules escamoses
dc.description.abstract
Background
Simlukafusp alfa (FAP-IL2v) is an immune cytokine engineered to selectively promote immune responses in the tumour microenvironment. We evaluated the antitumour activity and safety of FAP-IL2v plus atezolizumab in recurrent and/or metastatic cervical squamous cell carcinoma (SCC) in a phase 2 basket study (NCT03386721).
Methods
Patients with confirmed metastatic, persistent or recurrent cervical SCC who had progressed on ≥1 anti-cancer therapy and had measurable disease were enrolled. FAP-IL2v 10 mg was administered once every 3 weeks (Q3W) or once weekly (QW) for 4 weeks then once every 2 weeks (Q2W) with the corresponding Q3W or Q2W atezolizumab regimens. The primary endpoint was objective response rate by investigator assessment.
Findings
Forty-eight patients were enrolled (Q3W: n = 47; QW/Q2W: n = 1). Among 45 response evaluable patients, objective responses occurred in 12 patients (27%; CI 16.0–41.0), including 3 complete and 9 partial responses. Responses occurred in 6/19 PD-L1 positive patients (32%; 95% CI 15.4–54.0) and 5/24 PD-L1 negative patients (21%; 95% CI 9.2–35.6). Median duration of response was 13.3 months (95% CI 7.6–NE). Median progression-free survival was 3.7 months (95% CI 3.3–9.0). Adverse events (AEs) were consistent with the known safety profile of each drug. AEs leading to withdrawal of either agent occurred in 6 patients (13%). Pronounced expansion and activation of natural killer and CD8 T cells in peripheral blood and increased tumour infiltration and inflammation were observed.
Interpretation
FAP-IL2v plus atezolizumab is clinically active and has manageable safety in patients with recurrent and/or metastatic cervical SCC.
dc.description.abstract
F. Hoffmann-La Roche Ltd.
dc.format
application/pdf
dc.relation
eBioMedicine;109
dc.relation
https://doi.org/10.1016/j.ebiom.2024.105374
dc.rights
Attribution-NonCommercial 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Quimioteràpia combinada
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Coll uterí - Càncer - Tractament
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Anticossos monoclonals - Ús terapèutic
dc.subject
DISEASES::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms, Female::Uterine Neoplasms::Uterine Cervical Neoplasms
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Other subheadings::Other subheadings::Other subheadings::/drug therapy
dc.subject
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
dc.subject
DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Carcinoma, Squamous Cell
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CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized
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ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales femeninos::neoplasias uterinas::neoplasias del cuello uterino
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Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
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TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
dc.subject
ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::carcinoma de células escamosas
dc.subject
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados
dc.title
Phase 2 study of the antitumour activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in patients with recurrent and/or metastatic cervical squamous cell carcinoma
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
