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    Avelumab in combination regimens for relapsed/refractory DLBCL: results from the Phase Ib JAVELIN DLBCL study

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    Authors
    Hawkes, E. A.
    Phillips, T.
    Budde, L. E.
    Santoro, A.
    Saba, N. S.
    Roncolato, F.
    Gregory, G. P.
    Verhoef, G.
    Offner, F.
    Quero, C.
    Radford, John A
    Giannopoulos, K.
    Stevens, D.
    Thall, A.
    Huang, B.
    Laird, A. D.
    Sandner, R.
    Ansell, S. M.
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    Affiliation
    Olivia Newton-John Cancer Research Institute, Austin Health, 145 Studley Road, Heidelberg, VIC, Australia.
    Issue Date
    2021
    
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    Abstract
    Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: The low level of clinical activity suggests that PD-L1 inhibitor activity may be limited in R/R DLBCL. CLINICALTRIALS.
    Citation
    Hawkes EA, Phillips T, Budde LE, Santoro A, Saba NS, Roncolato F, et al. Avelumab in Combination Regimens for Relapsed/Refractory DLBCL: Results from the Phase Ib JAVELIN DLBCL Study [Internet]. Vol. 16, Targeted Oncology. Springer Science and Business Media LLC; 2021. p. 761–71.
    Journal
    Targeted Oncology
    URI
    http://hdl.handle.net/10541/624766
    DOI
    10.1007/s11523-021-00849-8
    PubMed ID
    34687398
    Additional Links
    https://dx.doi.org/10.1007/s11523-021-00849-8
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1007/s11523-021-00849-8
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