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Regomune: A phase II study of regorafenib plus avelumab in solid tumors - Results of the advanced or metastatic gastrointestinal stromal tumors (mGIST) cohort

dc.rights.licenseopenen_US
dc.contributor.authorCOUSIN, S.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBELLERA, Carine
dc.contributor.authorGUEGAN, Jean Philippe
dc.contributor.authorVALENTIN, T.
dc.contributor.authorVERRET, B.
dc.contributor.authorMETGES, J. P.
dc.contributor.authorADENIS, A.
dc.contributor.authorCASSIER, P.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBOUTEILLER, Fanny
dc.contributor.authorCERUSO, M. S.
dc.contributor.authorKORAKIS, I.
dc.contributor.authorHOLLEBECQUE, A.
dc.contributor.authorPOUREAU, P. G.
dc.contributor.authorPALUSSIERE, J.
dc.contributor.authorKIND, M.
dc.contributor.authorSOUBEYRAN, I.
dc.contributor.authorBESSEDE, A.
dc.contributor.authorITALIANO, A.
dc.date.accessioned2024-01-22T10:29:19Z
dc.date.available2024-01-22T10:29:19Z
dc.date.issued2023-10
dc.date.conference2023-10-20
dc.identifier.issn0923-7534en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/187362
dc.description.abstractEnBackground Regorafenib (R) has been approved as 3d line in mGIST patients (pts), with a median progression-free survival (mPFS) of 4.9 months (GRID study). R can alleviate the immunosuppressive GIST tumor micro environment by several mechanisms such as modifying the polarization of tumor-associated macrophages, reducing T regs infiltration. Thus, combining anti-PD1/PDL1 agents with anti-angiogenics appears promising in this population. Methods This is a single-arm open-label multicentric phase II trial assessing the efficacy and safety of R (160 mg QD 3weeks/4) + Avelumab (A) (10 mg/kg every 2 weeks) combination in pts with mGIST. The primary endpoint was the 6-month progression-free rate (6-month PFR) based on RECIST 1.1 criteria after central review. Secondary endpoints included: 6-month objective response, 1-year PFS, 1-year overall survival (OS), and safety using NCI-CTCAE v5.0. Correlative studies were planned from pts tumor samples obtained at baseline. Results Between November 2018 to July 2022, 50 pts were enrolled in 6 centers. Median age was 64 (range: 26-82). Median follow-up was 28.6 months (95% CI: 15.5 – 35.2). Median number of previous treatment lines was: 2 (range: 1-4). 42 (84%) pts experienced at least 1 dose modification or treatment interruption due to R and/or A. The most common grade 3/4 adverse events were: Palma-plantar erythrodysesthesia syndrome (18% of pts), hypertension (14%), diarrhea and maculopapular rash (12% each). No death was related to the treatment. Among the 46 assessable pts, 6-month PFR is 37% (N=17): 3 (6.5%) had partial response, 14 (30.4%) a stable disease, 23 (50%) a progressive disease, 6 were not evaluable. 24 (52.2%) had tumor shrinkage. Median PFS and OS are 5.5 months (95% CI: 3.6 – 7.5) and 19.5 months (95% CI: 13.7-33.5) respectively. 22% of pts are progression-free at one year. 6-month and 1-year OS rates are 93.5% (95% CI: 81.1-97.8) and 70.8% (95%CI: 55-81.9) respectively. Conclusions Regomune is the largest prospective study evaluating an approved TKI in combination with an IO agent in pts with advanced GIST. A subset of pts derived long term clinical benefit. Correlative studies will be presented at the meeting.
dc.language.isoENen_US
dc.title.enRegomune: A phase II study of regorafenib plus avelumab in solid tumors - Results of the advanced or metastatic gastrointestinal stromal tumors (mGIST) cohort
dc.typeCommunication dans un congrèsen_US
dc.identifier.doi10.1016/j.annonc.2023.09.1149en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
bordeaux.pageS1033-S1033en_US
bordeaux.volume34en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issuesupplement 2en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.conference.titleESMO Congress 2023en_US
bordeaux.countryesen_US
bordeaux.title.proceedingAbstract Book of the ESMO Congress 2023, 20 - 24 October 2023en_US
bordeaux.teamEPICENE_BPHen_US
bordeaux.teamBIOSTAT_BPHen_US
bordeaux.conference.cityMadriden_US
bordeaux.identifier.funderIDBayeren_US
bordeaux.identifier.funderIDMercken_US
hal.identifierhal-04409165
hal.version1
hal.date.transferred2024-01-22T10:29:21Z
hal.invitedouien_US
hal.proceedingsouien_US
hal.conference.end2023-10-24
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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