Phase II Study to Determine the Antitumor Activity and Safety of Simlukafusp Alfa (FAP-IL2v) Combined with Atezolizumab in Esophageal Cancer.
Journal
Clinical cancer research : an official journal of the American Association for Cancer Research
Journal Volume
30
Journal Issue
14
Start Page
2945
End Page
2953
ISSN
1557-3265
Date Issued
2024-07-15
Author(s)
Prenen, Hans
Deva, Sanjeev
Keam, Bhumsuk
Lindsay, Colin R
Lugowska, Iwona
Longo, Federico
de Miguel, Maria
Ponz-Sarvise, Mariano
Ahn, Myung-Ju
Gumus, Mahmut
Champiat, Stephane
Italiano, Antoine
Salas, Sébastien
Perets, Ruth
Arslan, Cagatay
Cho, Byoung C
Evers, Stefan
Boetsch, Christophe
Marbach, Daniel
Dejardin, David
Sleiman, Nassim
Ardeshir, Caroline
Richard, Muriel
Charo, Jehad
Kraxner, Anton
Keshelava, Nino
Teichgräber, Volker
Moreno, Victor
Abstract
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).
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-naïve. 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).
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.
FAP-IL2v plus atezolizumab demonstrated clinical activity and was tolerable in patients with previously treated esophageal SCC.
SDGs
Type
journal article