{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T14:58:34Z","timestamp":1790521114531,"version":"4.1.0"},"reference-count":30,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2022,7,19]],"date-time":"2022-07-19T00:00:00Z","timestamp":1658188800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006436","name":"Celgene","doi-asserted-by":"publisher","award":["NCT02733042"],"award-info":[{"award-number":["NCT02733042"]}],"id":[{"id":"10.13039\/100006436","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Reports"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Studies suggest that immune checkpoint inhibitors may represent a promising strategy for boosting immune responses and improving the antitumor activity of standard therapies in patients with relapsed\/refractory hematologic malignancies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>Phase 1\/2 FUSION NHL 001 was designed to determine the safety and efficacy of durvalumab, an anti\u2010programmed death ligand 1 (PD\u2010L1) antibody, combined with standard\u2010of\u2010care therapies for lymphoma or chronic lymphocytic leukemia (CLL).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and Results<\/jats:title><jats:p>The primary endpoints were to determine the recommended phase 2 dose of the drugs used in combination with durvalumab (durvalumab was administered at the previously recommended dose of 1500\u2009mg every 4\u2009weeks) and to assess safety and tolerability. Patients were enrolled into one of four arms: durvalumab monotherapy (Arm D) or durvalumab in combination with lenalidomide \u00b1 rituximab (Arm A), ibrutinib (Arm B), or rituximab \u00b1 bendamustine (Arm C). A total of 106 patients with relapsed\/refractory lymphoma were enrolled. All but two patients experienced at least one treatment\u2010emergent adverse event (TEAE); those not experiencing a TEAE were in Arm C (diffuse large B\u2010cell lymphoma [DLBCL]) and Arm D (DLBCL during the durvalumab monotherapy treatment period). No new safety signals were identified, and TEAEs were consistent with the respective safety profiles for each study treatment. Across the study, patients with follicular lymphoma (FL; <jats:italic>n<\/jats:italic>\u00a0=\u200923) had an overall response rate (ORR) of 59%; ORR among DLBCL patients (<jats:italic>n<\/jats:italic>\u00a0=\u200937) was 18%. Exploratory biomarker analysis showed that response to durvalumab monotherapy or combination therapy was associated with higher interferon\u2010\u03b3 signature scores in patients with FL (<jats:italic>p<\/jats:italic>\u00a0=\u2009.02).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Durvalumab as monotherapy or in combination is tolerable but requires close monitoring. The high rate of TEAEs during this study may reflect on the difficulty in combining durvalumab with full doses of other agents. Durvalumab alone or in combination appeared to add limited benefit to therapy.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cnr2.1662","type":"journal-article","created":{"date-parts":[[2022,7,19]],"date-time":"2022-07-19T07:14:19Z","timestamp":1658214859000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Durvalumab as monotherapy and in combination therapy in patients with lymphoma or chronic lymphocytic leukemia: The <scp>FUSION NHL<\/scp> 001 trial"],"prefix":"10.1002","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4998-9932","authenticated-orcid":false,"given":"Carla","family":"Casulo","sequence":"first","affiliation":[{"name":"University of Rochester Medical Center Wilmot Cancer Institute  Rochester New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Armando","family":"Santoro","sequence":"additional","affiliation":[{"name":"Humanitas University and Humanitas Clinical and 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