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Regorafenib plus avelumab in advanced gastroenteropancreatic neuroendocrine neoplasms: a phase 2 trial and correlative analysis

dc.rights.licenseopenen_US
dc.contributor.authorCOUSIN, Sophie
dc.contributor.authorGUEGAN, Jean-Philippe
dc.contributor.authorPALMIERI, Lola Jade
dc.contributor.authorMETGES, Jean Philippe
dc.contributor.authorPERNOT, Simon
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBELLERA, Carine A
dc.contributor.authorASSENAT, Eric
dc.contributor.authorKORAKIS, Iphigenie
dc.contributor.authorCASSIER, Philippe Alexandre
dc.contributor.authorHOLLEBECQUE, Antoine
dc.contributor.authorCANTAREL, Coralie
dc.contributor.authorKIND, Michele
dc.contributor.authorSOUBEYRAN, Isabelle
dc.contributor.authorSOKOL, Harry
dc.contributor.authorVANHERSECKE, Lucile
dc.contributor.authorBESSEDE, Alban
dc.contributor.authorITALIANO, Antoine
dc.date.accessioned2025-05-27T09:36:50Z
dc.date.available2025-05-27T09:36:50Z
dc.date.issued2025-04-01
dc.identifier.issn2662-1347en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/206744
dc.description.abstractEnGastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) are heterogeneous tumors with limited treatment options. This phase 2 Bayesian study evaluated the combination of regorafenib, a multikinase inhibitor, and avelumab, a programmed death 1 (PD1) ligand 1 inhibitor, in advanced grade 2-grade 3 well-differentiated GEP neuroendocrine tumors or grade 3 GEP neuroendocrine carcinomas after progression on prior therapies. A total of 47 participants were enrolled and 42 were evaluable for efficacy. Participants received regorafenib (160 mg per day) and avelumab (10 mg kg-1 biweekly) in 28-day cycles. The primary endpoint, 6-month objective response rate per the response evaluation criteria in solid tumors version 1.1, was 18% (95% confidence interval (CI): 8-31%), with a median progression-free survival of 5.5 months (95% CI: 3.6-8). Durable responses were noted (16.6 months; 95% CI: 3.7-no response). Treatment-related adverse events were manageable, with fatigue, diarrhea and palmar-plantar erythrodysesthesia being most common. Exploratory biomarker analysis identified PD1 and indoleamine 2,3-dioxygenase 1 expression and activity as potential resistance markers. These findings highlight the clinical potential of regorafenib and avelumab in GEP-NENs, emphasizing the need for predictive biomarkers and validation in future randomized trials. Clinical Trial registration:NCT03475953.
dc.language.isoENen_US
dc.title.enRegorafenib plus avelumab in advanced gastroenteropancreatic neuroendocrine neoplasms: a phase 2 trial and correlative analysis
dc.title.alternativeNat Canceren_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1038/s43018-025-00916-3en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed40204996en_US
bordeaux.journalNature Canceren_US
bordeaux.page584-594en_US
bordeaux.volume6en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue4en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamEPICENE_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-05086448
hal.version1
hal.date.transferred2025-05-27T09:36:52Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Nature%20Cancer&rft.date=2025-04-01&rft.volume=6&rft.issue=4&rft.spage=584-594&rft.epage=584-594&rft.eissn=2662-1347&rft.issn=2662-1347&rft.au=COUSIN,%20Sophie&GUEGAN,%20Jean-Philippe&PALMIERI,%20Lola%20Jade&METGES,%20Jean%20Philippe&PERNOT,%20Simon&rft.genre=article


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