Phase II study to determine the anti-tumor activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in esophageal cancer
Prenen, H. Deva, S. Keam, B. Lindsay, Colin R Lugowska, I. Yang, J. C. Longo, F. de Miguel, M. Ponz-Sarvise, M. Ahn, M. J.
Prenen, H.
Deva, S.
Keam, B.
Lindsay, Colin R
Lugowska, I.
Yang, J. C.
Longo, F.
de Miguel, M.
Ponz-Sarvise, M.
Ahn, M. J.
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Abstract
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.
Authors
Prenen, H.
Deva, S.
Keam, B.
Lindsay, Colin R
Lugowska, I.
Yang, J. C.
Longo, F.
de Miguel, M.
Ponz-Sarvise, M.
Ahn, M. J.
Gumus, M.
Champiat, S.
Italiano, A.
Salas, S.
Perets, R.
Arslan, C.
Cho, B. C.
Evers, S.
Boetsch, C.
Marbach, D.
Dejardin, D.
Sleiman, N.
Ardeshir, C.
Richard, M.
Charo, J.
Kraxner, A.
Keshelava, N.
Teichgräber, V.
Moreno, V.
Deva, S.
Keam, B.
Lindsay, Colin R
Lugowska, I.
Yang, J. C.
Longo, F.
de Miguel, M.
Ponz-Sarvise, M.
Ahn, M. J.
Gumus, M.
Champiat, S.
Italiano, A.
Salas, S.
Perets, R.
Arslan, C.
Cho, B. C.
Evers, S.
Boetsch, C.
Marbach, D.
Dejardin, D.
Sleiman, N.
Ardeshir, C.
Richard, M.
Charo, J.
Kraxner, A.
Keshelava, N.
Teichgräber, V.
Moreno, V.
Description
Date
2024
Publisher
Collections
Keywords
Type
Article
Citation
Prenen H, Deva S, Keam B, Lindsay CR, Lugowska I, Yang JC, et al. Phase II study to determine the anti-tumor activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in esophageal cancer. Clinical cancer research : an official journal of the American Association for Cancer Research. 2024 May 6. PubMed PMID: 38709220. Epub 2024/05/06. eng.