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Pembrolizumab in soft-tissue sarcomas with tertiary lymphoid structures: a phase 2 PEMBROSARC trial cohort

dc.rights.licenseopenen_US
dc.contributor.authorITALIANO, Antoine
dc.contributor.authorBESSEDE, Alban
dc.contributor.authorPULIDO, Marina
dc.contributor.authorBOMPAS, Emmanuelle
dc.contributor.authorPIPERNO-NEUMANN, Sophie
dc.contributor.authorCHEVREAU, Christine
dc.contributor.authorPENEL, Nicolas
dc.contributor.authorBERTUCCI, Francois
dc.contributor.authorTOULMONDE, Maud
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBELLERA, Carine
dc.contributor.authorGUEGAN, Jean Philippe
dc.contributor.authorREY, C.
dc.contributor.authorSAUTES-FRIDMAN, Catherine
dc.contributor.authorBOUGOUIN, Antoine
dc.contributor.authorCANTAREL, Coralie
dc.contributor.authorKIND, Michele
dc.contributor.authorSPALATO, M.
dc.contributor.authorDADONE-MONTAUDIE, B.
dc.contributor.authorLE LOARER, Francois
dc.contributor.authorBLAY, Jean Yves
dc.contributor.authorFRIDMAN, Wolf H.
dc.date.accessioned2022-07-12T13:53:45Z
dc.date.available2022-07-12T13:53:45Z
dc.date.issued2022-06
dc.identifier.issn1546-170X (Electronic) 1078-8956 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/140447
dc.description.abstractEnImmune checkpoint inhibitors (ICIs) show limited clinical activity in patients with advanced soft-tissue sarcomas (STSs). Retrospective analysis suggests that intratumoral tertiary lymphoid structures (TLSs) are associated with improved outcome in these patients. PEMBROSARC is a multicohort phase 2 study of pembrolizumab combined with low-dose cyclophosphamide in patients with advanced STS (NCT02406781). The primary endpoint was the 6-month non-progression rate (NPR). Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and safety. The 6-month NPR and ORRs for cohorts in this trial enrolling all comers were previously reported; here, we report the results of a cohort enrolling patients selected based on the presence of TLSs (n = 30). The 6-month NPR was 40% (95% confidence interval (CI), 22.7-59.4), so the primary endpoint was met. The ORR was 30% (95% CI, 14.7-49.4). In comparison, the 6-month NPR and ORR were 4.9% (95% CI, 0.6-16.5) and 2.4% (95% CI, 0.1-12.9), respectively, in the all-comer cohorts. The most frequent toxicities were grade 1 or 2 fatigue, nausea, dysthyroidism, diarrhea and anemia. Exploratory analyses revealed that the abundance of intratumoral plasma cells (PCs) was significantly associated with improved outcome. These results suggest that TLS presence in advanced STS is a potential predictive biomarker to improve patients' selection for pembrolizumab treatment.
dc.language.isoENen_US
dc.title.enPembrolizumab in soft-tissue sarcomas with tertiary lymphoid structures: a phase 2 PEMBROSARC trial cohort
dc.typeArticle de revueen_US
dc.identifier.doi10.1038/s41591-022-01821-3en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed35618839en_US
bordeaux.journalNature Medicineen_US
bordeaux.page1199-1206en_US
bordeaux.volume28en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue6en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamEPICENE_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03721377
hal.version1
hal.date.transferred2022-07-12T13:53:53Z
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%20Medicine&rft.date=2022-06&rft.volume=28&rft.issue=6&rft.spage=1199-1206&rft.epage=1199-1206&rft.eissn=1546-170X%20(Electronic)%201078-8956%20(Linking)&rft.issn=1546-170X%20(Electronic)%201078-8956%20(Linking)&rft.au=ITALIANO,%20Antoine&BESSEDE,%20Alban&PULIDO,%20Marina&BOMPAS,%20Emmanuelle&PIPERNO-NEUMANN,%20Sophie&rft.genre=article


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