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dc.contributor.authorHawkes, Eliza A-
dc.contributor.authorPhillips, Tycel-
dc.contributor.authorBudde, Lihua Elizabeth-
dc.contributor.authorSantoro, Armando-
dc.contributor.authorSaba, Nakhle S-
dc.contributor.authorRoncolato, Fernando-
dc.contributor.authorGregory, Gareth P-
dc.contributor.authorVerhoef, Gregor-
dc.contributor.authorOffner, Fritz-
dc.contributor.authorQuero, Cristina-
dc.contributor.authorRadford, John-
dc.contributor.authorGiannopoulos, Krzysztof-
dc.contributor.authorStevens, Don-
dc.contributor.authorThall, Aron-
dc.contributor.authorHuang, Bo-
dc.contributor.authorLaird, A Douglas-
dc.contributor.authorSandner, Robin-
dc.contributor.authorAnsell, Stephen M-
dc.identifier.citationTargeted oncology 2021; 16(6): 761-771en
dc.description.abstractRelapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) is associated with a poor prognosis despite the availability of multiple treatment options. Preliminary evidence suggests that DLBCL may be responsive to programmed death ligand 1 (PD-L1)/programmed death 1 inhibitors. The JAVELIN DLBCL study was conducted to assess whether a combination of agents could augment and sustain the antitumor immunity of avelumab, an anti-PD-L1 antibody, in R/R DLBCL. This was a multicenter, randomized, open-label, parallel-arm study with a phase Ib and a phase III component. Reported here are the results from the phase Ib study, wherein 29 adult patients with DLBCL were randomized 1:1:1 to receive avelumab in combination with utomilumab (an immunoglobulin G2 4-1BB agonist) and rituximab (arm A), avelumab in combination with utomilumab and azacitidine (arm B), or avelumab in combination with bendamustine and rituximab (arm C). The primary endpoints were dose-limiting toxicities and objective response as assessed by the investigator per Lugano Response Classification criteria. Of the seven patients in arm A, one (14.3%) experienced two grade 3 dose-limiting toxicities (herpes zoster and ophthalmic herpes zoster); no dose-limiting toxicities were reported in arms B or C. No new safety concerns emerged for avelumab. One partial response was reported in arm A, three complete responses in arm C, and no responses in arm B. Given the insufficient antitumor activity in arms A and B and the infeasibility of expanding arm C, the study was discontinued before initiation of the phase III component. The low level of clinical activity suggests that PD-L1 inhibitor activity may be limited in R/R DLBCL. CLINICALTRIALS. NCT02951156.en
dc.titleAvelumab in Combination Regimens for Relapsed/Refractory DLBCL: Results from the Phase Ib JAVELIN DLBCL Study.en
dc.typeJournal Articleen
dc.identifier.journaltitleTargeted Oncologyen
dc.identifier.affiliationPfizer Inc, Groton, CT, USAen
dc.identifier.affiliationPfizer Inc, La Jolla, CA, USAen
dc.identifier.affiliationPfizer Inc, Collegeville, PA, USAen
dc.identifier.affiliationUniversity of Michigan Health System, Ann Arbor, MI, USAen
dc.identifier.affiliationCity of Hope, Duarte, CA, USAen
dc.identifier.affiliationMayo Clinic, Rochester, MN, USAen
dc.identifier.affiliationSection of Hematology and Medical Oncology, Deming Department of Medicine, Tulane University, New Orleans, LA, USAen
dc.identifier.affiliationNorton Cancer Institute, Louisville, KY, USAen
dc.identifier.affiliationDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italyen
dc.identifier.affiliationHumanitas Clinical and Research Center IRCCS, Rozzano-Milano, Italyen
dc.identifier.affiliationOlivia Newton-John Cancer Research Instituteen
dc.identifier.affiliationSt. George Hospital, Kogarah, NSW, Australiaen
dc.identifier.affiliationSchool of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australiaen
dc.identifier.affiliationUZ Leuven, Leuven, Belgiumen
dc.identifier.affiliationUZ Gent, Gent, Belgiumen
dc.identifier.affiliationHospital Universitario Virgen de la Victoria, Málaga, Spainen
dc.identifier.affiliationNIHR Manchester Clinical Research Facility, The Christie NHS Foundation Trust and University of Manchester, Manchester, UKen
dc.identifier.affiliationExperimental Hematooncology Department, St. John's Cancer Center, Medical University of Lublin, Lublin, Polanden
dc.identifier.pubmedid34687398-, Eliza A
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
item.languageiso639-1en- Haematology- Newton-John Cancer Wellness and Research Centre- Newton-John Cancer Research Institute-
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