Browsing by Author "Prenen, Hans"

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Citation - WoS: 5
Citation - Scopus: 4
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
(Elsevier, 2024) Verlingue, Loic; Italiano, Antoine; Prenen, Hans; Alia, Eva Maria Guerra; Tosi, Diego; Perets, Ruth; Lugowska, Iwona; Arslan, Cagatay
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 fi rmed metastatic, persistent or recurrent cervical SCC who had progressed on >= 1 anticancer 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), - 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) - 54.0) and 5/24 PD-L1 negative patients (21%; 95% CI 9.2-35.6). - 35.6). Median duration of response was 13.3 months (95% CI 7.6-NE). - NE). Median progression- free survival was 3.7 months (95% CI 3.3-9.0). - 9.0). Adverse events (AEs) were consistent with the known safety profile fi le 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 fi ltration and inflammation fl ammation were observed. Interpretation FAP-IL2v plus atezolizumab is clinically active and has manageable safety in patients with recurrent and/or metastatic cervical SCC.
Citation - WoS: 6
Citation - Scopus: 6
Phase Ii Study To Determine the Antitumor Activity and Safety of Simlukafusp Alfa (fap-Il2v) Combined With Atezolizumab in Esophageal Cancer
(Amer assoc cancer research, 2024) Prenen, Hans; Deva, Sanjeev; Keam, Bhumsuk; Lindsay, Colin R.; Lugowska, Iwona; Yang, James C.; Longo, Federico; Arslan, Cagatay
Purpose: In this study, we report the results from the esophageal squamous cell carcinoma (SCC) cohort of a phase II, noncomparative, basket study evaluating the antitumor activity and safety of fibroblast activation protein-IL2 variant (FAP-IL2v) plus atezolizumab in patients with advanced/metastatic solid tumors (NCT03386721). Patients and Methods: Eligible patients had an Eastern Cooperative Oncology Group performance status of 0 to 1; measurable metastatic, persistent, or recurrent esophageal SCC; progression on >= 1 prior therapy; and were checkpoint inhibitor-na & iuml;ve. Patients received FAP-IL2v 10 mg plus atezolizumab 1,200 mg intravenously every 3 weeks, or FAP-IL2v weekly for 4 weeks and then every 2 weeks plus atezolizumab 840 mg intravenously every 2 weeks. The primary endpoint was investigator-assessed objective response rate (ORR). Results: In the response-evaluable population (N = 34), the best confirmed ORR was 20.6% [95% confidence interval (CI), 10.4-36.8], with a complete response seen in 1 patient and partial responses in 6 patients. The disease control rate was 44.1% (complete response = 2.9%; partial response = 17.6%; stable disease = 23.5%), and the median duration of response was 10.1 mon/ths (95% CI, 5.6-26.7). The median progression-free survival was 1.9 months (95% CI, 1.8-3.7). Analysis of response by PDL1 expression (Ventana SP263) resulted in an ORR of 26.7% for patients with PDL1-positive tumors (tumor area positivity cutoff >= 1%; n = 15) and 7.1% for patients with PDL1-negative tumors (tumor area positivity cutoff <1%; n = 14). Overall, the treatment combination was tolerable, and adverse events were consistent with the known safety profiles of each drug. Conclusions: FAP-IL2v plus atezolizumab demonstrated clinical activity and was tolerable in patients with previously treated esophageal SCC.