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Title: Avelumab in Combination Regimens for Relapsed/Refractory DLBCL: Results from the Phase Ib JAVELIN DLBCL Study.
Austin Authors: Hawkes, Eliza A ;Phillips, Tycel;Budde, Lihua Elizabeth;Santoro, Armando;Saba, Nakhle S;Roncolato, Fernando;Gregory, Gareth P;Verhoef, Gregor;Offner, Fritz;Quero, Cristina;Radford, John;Giannopoulos, Krzysztof;Stevens, Don;Thall, Aron;Huang, Bo;Laird, A Douglas;Sandner, Robin;Ansell, Stephen M
Affiliation: Pfizer Inc, Groton, CT, USA
Pfizer Inc, La Jolla, CA, USA
Pfizer Inc, Collegeville, PA, USA
University of Michigan Health System, Ann Arbor, MI, USA
City of Hope, Duarte, CA, USA
Mayo Clinic, Rochester, MN, USA
Section of Hematology and Medical Oncology, Deming Department of Medicine, Tulane University, New Orleans, LA, USA
Norton Cancer Institute, Louisville, KY, USA
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy
Humanitas Clinical and Research Center IRCCS, Rozzano-Milano, Italy
Olivia Newton-John Cancer Research Institute
St. George Hospital, Kogarah, NSW, Australia
School of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia
UZ Leuven, Leuven, Belgium
UZ Gent, Gent, Belgium
Hospital Universitario Virgen de la Victoria, Málaga, Spain
NIHR Manchester Clinical Research Facility, The Christie NHS Foundation Trust and University of Manchester, Manchester, UK
Experimental Hematooncology Department, St. John's Cancer Center, Medical University of Lublin, Lublin, Poland
Issue Date: 2021
Date: 2021-10-23
Publication information: Targeted oncology 2021; 16(6): 761-771
Abstract: Relapsed/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.
DOI: 10.1007/s11523-021-00849-8
Journal: Targeted Oncology
PubMed URL: 34687398
Type: Journal Article
Appears in Collections:Journal articles

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