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
Verlingue, L. Italiano, A. Prenen, H. Guerra Alia, E. M. Tosi, D. Perets, R. Lugowska, I. Moiseyenko, V. Gumus, M. Arslan, C.
Verlingue, L.
Italiano, A.
Prenen, H.
Guerra Alia, E. M.
Tosi, D.
Perets, R.
Lugowska, I.
Moiseyenko, V.
Gumus, M.
Arslan, C.
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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. FUNDING: F. Hoffmann-La Roche Ltd.
Authors
Verlingue, L.
Italiano, A.
Prenen, H.
Guerra Alia, E. M.
Tosi, D.
Perets, R.
Lugowska, I.
Moiseyenko, V.
Gumus, M.
Arslan, C.
Lindsay, Colin R
Deva, S.
Taus, Á.
Oaknin, A.
Rottey, S.
Cicin, I.
Goksu, S. S.
Smolin, A.
Roselló-Keränen, S.
Habigt, C.
Marbach, D.
Boetsch, C.
Dejardin, D.
Sleiman, N.
Evers, S.
Richard, M.
Ardeshir, C.
Charo, J.
Kraxner, A.
Teichgräber, V.
Keshelava, N.
Dziadziuszko, R.
Italiano, A.
Prenen, H.
Guerra Alia, E. M.
Tosi, D.
Perets, R.
Lugowska, I.
Moiseyenko, V.
Gumus, M.
Arslan, C.
Lindsay, Colin R
Deva, S.
Taus, Á.
Oaknin, A.
Rottey, S.
Cicin, I.
Goksu, S. S.
Smolin, A.
Roselló-Keränen, S.
Habigt, C.
Marbach, D.
Boetsch, C.
Dejardin, D.
Sleiman, N.
Evers, S.
Richard, M.
Ardeshir, C.
Charo, J.
Kraxner, A.
Teichgräber, V.
Keshelava, N.
Dziadziuszko, R.
Description
Date
2024
Publisher
Collections
Keywords
Type
Article
Citation
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. PubMed PMID: 39395231. Epub 2024/10/12 21:47. eng.