Publicaciones científicas
Phase II study to determine the anti-tumor activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in esophageal cancer
Hans Prenen 1 , Sanjeev Deva 2 , Bhumsuk Keam 3 , Colin R Lindsay 4 , Iwona Lugowska 5 , James C Yang 6 , Federico Longo 7 , Maria de Miguel 8 , Mariano Ponz-Sarvise 9 , Myung-Ju Ahn 10 , Mahmut Gumus 11 , Stephane Champiat 12 , Antoine Italiano 13 , Sebastien Salas 14 , Ruth Perets 15 , Cagatay Arslan 16 , Byoung C Cho 17 , Stefan Evers 18 , Christophe Boetsch 19 , Daniel Marbach 20 , David Dejardin 19 , Nassim Sleiman 21 , Caroline Ardeshir 22 , Muriel Richard 23 , Jehad Charo 24 , Anton Kraxner 19 , Nino Keshelava 25 , Volker Teichgräber 19 , Victor Moreno 26
Purpose: Reported here are results from the esophageal squamous cell carcinoma (SCC) cohort of a Phase II, non-comparative, basket study, evaluating the anti-tumor activity and safety of FAP-IL2v plus atezolizumab in patients with advanced/metastatic solid tumors (NCT03386721).
Experimental design: Eligible patients had an Eastern Cooperative Oncology Group performance status of 0-1; measurable metastatic, persistent, or recurrent esophageal SCC; progression on ≥1 prior therapy; and were checkpoint inhibitor naive. Patients received FAP-IL2v 10 mg plus atezolizumab 1200 mg intravenously every 3 weeks, or FAP-IL2v weekly for 4 weeks, then every 2 weeks, plus atezolizumab 840 mg intravenously every 2 weeks. Primary endpoint was investigator-assessed objective response rate (ORR).
Results: In the response-evaluable population (N=34), best confirmed ORR was 20.6% (95% confidence interval [CI]: 10.4-36.8) with a complete response (CR) seen in one patient and partial responses (PR) in six patients. Disease control rate was 44.1% (CR=2.9%; PR=17.6%; stable disease [SD]=23.5%) and median duration of response was 10.1 months (95% CI: 5.6-26.7). Median progression-free survival was 1.9 months (95% CI: 1.8-3.7). Analysis of response by PD-L1 expression (Ventana SP263) resulted in an ORR of 26.7 % for patients with PD-L1-positive tumors (tumor area positivity [TAP] cut-off ≥1%; n=15) and 7.1% for patients with PD-L1-negative tumors (TAP cut-off <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.
CITA DEL ARTÍCULO Clin Cancer Res. 2024 May 6. doi: 10.1158/1078-0432.CCR-23-2677
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