{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T22:08:19Z","timestamp":1793830099133,"version":"4.6.1"},"reference-count":37,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T00:00:00Z","timestamp":1775692800000},"content-version":"unspecified","delay-in-days":8,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004337","name":"F. Hoffmann-La Roche Ltd","doi-asserted-by":"crossref","award":["No grant number is applicable"],"award-info":[{"award-number":["No grant number is applicable"]}],"id":[{"id":"10.13039\/100004337","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2026,2,2]]},"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Simlukafusp alfa (FAP-IL2v) was engineered to preferentially activate CD8+ T\u2009and natural killer (NK) cells in tumor microenvironments overexpressing fibroblast activation protein (FAP). Checkpoint inhibitors combined with antiangiogenic agents are standard therapy for metastatic renal cell carcinoma (mRCC), which overexpresses FAP. Here, we explored the efficacy, safety, and pharmacodynamic effects of FAP-IL2v in combination with atezolizumab with or without bevacizumab in patients with mRCC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients with treatment-na\u00efve or pretreated clear cell and\/or sarcomatoid mRCC were eligible. Dose escalation explored FAP-IL2v every 2 weeks (Q2W) with atezolizumab Q2W (doublet, arm A), and with atezolizumab and bevacizumab Q2W (triplet, arm B) in patients treated with up to one prior systemic therapy. Dose extension explored in untreated patients the recommended FAP-IL2v dose administered Q2W (doublet, arm A; and triplet, arm B) or 3-weekly (doublet, arm C; and triplet, arm D). Primary objectives were the recommended FAP-IL2v dose and antitumor activity. Secondary objectives included safety, pharmacodynamics, and exploratory biomarkers in peripheral blood and paired biopsies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>By the data cut-off date (31 August, 2021), 66\u2009patients were enrolled. The median duration of treatment was 11.0\u2009months. Objective response rates (ORRs) were 25% for the doublet and 47% for the triplet, and median progression-free survival was 6.3 and 18.3\u2009months, respectively. Safety profiles were consistent with the individual drugs, including expected interleukin-2 (IL-2) class-specific adverse events (AEs). Two deaths were recorded caused by AEs related to study treatment (acute kidney injury, n=1; pancytopenia, n=1). Expansion and activation of NK and T cells, but not regulatory T cells, was observed in peripheral blood, leading to increased tumor infiltration and inflammation in paired biopsies. The addition of bevacizumab led to a reduced angiogenesis signature score and reduced vessel density.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The combination of FAP-IL2v plus atezolizumab with or without bevacizumab was consistent with the known safety profile of the individual drugs. The maximum tolerated dose was not reached, with a recommended FAP-IL2v dose of 10\u2009mg. ORR was higher among patients receiving the triplet therapy compared with the doublet. Pharmacodynamic results were consistent with the mechanism of action of IL-2, supporting further research in this field.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/jitc-2025-012466","type":"journal-article","created":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T16:15:26Z","timestamp":1775751326000},"page":"e012466","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Simlukafusp alfa (FAP-IL2v) plus atezolizumab with or without bevacizumab in unresectable, metastatic renal cell carcinoma: a randomized, open-label phase Ib study"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct03063762","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4941-9075","authenticated-orcid":false,"given":"Jose Luis","family":"Perez-Gracia","sequence":"first","affiliation":[{"name":"Department of Oncology, Clinica Universidad de Navarra, Pamplona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bego\u00f1a","family":"Mellado","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hospital Clinic de Barcelona, Barcelona, Spain"},{"name":"Translational Genomics and Targeted Therapies in Solid Tumors, IDIBAPS, Barcelona, Spain"},{"name":"Department of Medicine, University of Barcelona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2363-8707","authenticated-orcid":false,"given":"Aaron Richard","family":"Hansen","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada"},{"name":"Department of Medical Oncology, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa","family":"Alonso-Gordoa","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Hospital Universitario Ramon y Cajal, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8043-2529","authenticated-orcid":false,"given":"Carlos","family":"Gomez-Roca","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Institut Claudius Regaud, Toulouse, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rikke","family":"L\u00f8vendahl Eefsen","sequence":"additional","affiliation":[{"name":"Department of Oncology, Copenhagen University Hospital Rigshospitalet, Herlev, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvie","family":"Negrier","sequence":"additional","affiliation":[{"name":"Centre L\u00e9on B\u00e9rard, University of Lyon, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Su\u00e1rez","sequence":"additional","affiliation":[{"name":"Medical Oncology, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d\u2019Hebron, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jae-Lyun","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Oncology and Internal Medicine, Asan Medical Center, Songpa-gu, Korea (the Republic of)"},{"name":"Division of Oncology, Department of Internal Medicine, University of Ulsan College of Medicine, Songpa-gu, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arif","family":"Hussain","sequence":"additional","affiliation":[{"name":"University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Pedrazzoli","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Therapy, University of Pavia, Pavia, Italy"},{"name":"Department of Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6099-4236","authenticated-orcid":false,"given":"Victor","family":"Moreno","sequence":"additional","affiliation":[{"name":"START Madrid-FJD, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alejo","family":"Rodriguez-Vida","sequence":"additional","affiliation":[{"name":"CIBERONC, Hospital del Mar, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey Alan","family":"Sosman","sequence":"additional","affiliation":[{"name":"Department of Medicine, Robert H. 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