Sistema de Salut de Catalunya
Institut Català de la Salut
[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
Vall d'Hebron Barcelona Hospital Campus
2024-11-26T13:51:49Z
2024-11-26T13:51:49Z
2024-11
Cervical cancer; Immunotherapy; Squamous cell carcinoma
Cáncer de cuello uterino; Inmunoterapia; Carcinoma de células escamosas
Càncer de coll uterí; Immunoteràpia; Carcinoma de cèl·lules escamoses
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.
F. Hoffmann-La Roche Ltd.
Article
Published version
English
Quimioteràpia combinada; Coll uterí - Càncer - Tractament; Anticossos monoclonals - Ús terapèutic; DISEASES::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms, Female::Uterine Neoplasms::Uterine Cervical Neoplasms; Other subheadings::Other subheadings::Other subheadings::/drug therapy; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols; DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Carcinoma, Squamous Cell; CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized; ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales femeninos::neoplasias uterinas::neoplasias del cuello uterino; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada; ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::carcinoma de células escamosas; COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados
Elsevier
eBioMedicine;109
https://doi.org/10.1016/j.ebiom.2024.105374
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
