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Regorafenib-avelumab combination in patients with biliary tract cancer (REGOMUNE): a single-arm, open-label, phase II trial

dc.rights.licenseopenen_US
dc.contributor.authorCOUSIN, Sophie
dc.contributor.authorCANTAREL, Coralie
dc.contributor.authorGUEGAN, Jean-Philippe
dc.contributor.authorMAZARD, Thibault
dc.contributor.authorGOMEZ-ROCA, Carlos
dc.contributor.authorMETGES, Jean-Philippe
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBELLERA, Carine
dc.contributor.authorADENIS, Antoine
dc.contributor.authorKORAKIS, Iphigenie
dc.contributor.authorPOUREAU, Pierre-Guillaume
dc.contributor.authorBOURCIER, Kevin
dc.contributor.authorTOULMONDE, Maud
dc.contributor.authorKIND, Michele
dc.contributor.authorREY, Christophe
dc.contributor.authorAUZANNEAU, Celine
dc.contributor.authorBESSEDE, Alban
dc.contributor.authorSOUBEYRAN, Isabelle
dc.contributor.authorITALIANO, Antoine
dc.date.accessioned2022-07-15T10:26:55Z
dc.date.available2022-07-15T10:26:55Z
dc.date.issued2022-02
dc.identifier.issn1879-0852 (Electronic) 0959-8049 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/140503
dc.description.abstractEnBACKGROUND: Regorafenib has shown substantial clinical activity in patients with advanced biliary tract cancers (BTCs). Preclinical data suggested that this drug modulates antitumour immunity and is synergistic with immune checkpoint inhibition. PATIENTS AND METHODS: This is a single-arm, multicentric phase II trial. Regorafenib was given 3 weeks/4, 160 mg quaque die (once a day) (QD); avelumab 10 mg/kg IV was given every two weeks, beginning at C1D15 until progression or unacceptable toxicity. The primary end-point was the confirmed objective response rate under treatment, as per Response Evaluation Criteria in Solid Tumours 1.1. The secondary end-points included the following: 1-year non-progression rate; progression-free survival (PFS) and overall survival; safety and biomarkers studies performed on sequential tumour samples obtained at baseline and at cycle 2 day 1. RESULTS: Thirty-four patients were enrolled in four centres. Twenty-nine patients were assessable for efficacy after central radiological review. The best response was partial response for four patients (13.8%), stable disease for 11 patients (37.9%) and progressive disease for 14 patients (48.3%). The median PFS and overall survival were 2.5 months (95% confidence interval [CI] [1.9-5.5]) and 11.9 months (95%CI [6.2-NA]) respectively. The most common grade 3 or 4 clinical adverse events related to treatment were hypertension (17.6%), fatigue (14.7%) and maculopapular rash (11.8%). High baseline levels of programmed cell death ligand 1 and of indoleamine 2, 3-dioxygénase expression were associated with improved outcomes. CONCLUSIONS: Regorafenib combined with avelumab has antitumour activity in a subset of heavily pretreated biliary tract cancer population. Further investigations are needed in patients selected based on tumour microenvironment features. CLINICAL TRIAL REGISTRATION: NCT03475953.
dc.language.isoENen_US
dc.subject.enRegorafenib
dc.subject.enAvelumab
dc.subject.enBiliary tract cancer
dc.subject.enImmunotherapy
dc.subject.enCholangiocarcinoma
dc.title.enRegorafenib-avelumab combination in patients with biliary tract cancer (REGOMUNE): a single-arm, open-label, phase II trial
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.ejca.2021.11.012en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed34998048en_US
bordeaux.journalEuropean Journal of Canceren_US
bordeaux.page161-169en_US
bordeaux.volume162en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamEPICENE_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDInstitut Bergoniéen_US
hal.identifierhal-03723894
hal.version1
hal.date.transferred2022-07-15T10:27:03Z
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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