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.license | open | en_US |
| dc.contributor.author | COUSIN, S. | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | BELLERA, Carine | |
| dc.contributor.author | GUEGAN, Jean Philippe | |
| dc.contributor.author | VALENTIN, T. | |
| dc.contributor.author | VERRET, B. | |
| dc.contributor.author | METGES, J. P. | |
| dc.contributor.author | ADENIS, A. | |
| dc.contributor.author | CASSIER, P. | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | BOUTEILLER, Fanny | |
| dc.contributor.author | CERUSO, M. S. | |
| dc.contributor.author | KORAKIS, I. | |
| dc.contributor.author | HOLLEBECQUE, A. | |
| dc.contributor.author | POUREAU, P. G. | |
| dc.contributor.author | PALUSSIERE, J. | |
| dc.contributor.author | KIND, M. | |
| dc.contributor.author | SOUBEYRAN, I. | |
| dc.contributor.author | BESSEDE, A. | |
| dc.contributor.author | ITALIANO, A. | |
| dc.date.accessioned | 2024-01-22T10:29:19Z | |
| dc.date.available | 2024-01-22T10:29:19Z | |
| dc.date.issued | 2023-10 | |
| dc.date.conference | 2023-10-20 | |
| dc.identifier.issn | 0923-7534 | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/187362 | |
| dc.description.abstractEn | Background 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.iso | EN | en_US |
| dc.title.en | Regomune: A phase II study of regorafenib plus avelumab in solid tumors - Results of the advanced or metastatic gastrointestinal stromal tumors (mGIST) cohort | |
| dc.type | Communication dans un congrès | en_US |
| dc.identifier.doi | 10.1016/j.annonc.2023.09.1149 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| bordeaux.page | S1033-S1033 | en_US |
| bordeaux.volume | 34 | en_US |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
| bordeaux.issue | supplement 2 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.institution | INSERM | en_US |
| bordeaux.conference.title | ESMO Congress 2023 | en_US |
| bordeaux.country | es | en_US |
| bordeaux.title.proceeding | Abstract Book of the ESMO Congress 2023, 20 - 24 October 2023 | en_US |
| bordeaux.team | EPICENE_BPH | en_US |
| bordeaux.team | BIOSTAT_BPH | en_US |
| bordeaux.conference.city | Madrid | en_US |
| bordeaux.identifier.funderID | Bayer | en_US |
| bordeaux.identifier.funderID | Merck | en_US |
| hal.identifier | hal-04409165 | |
| hal.version | 1 | |
| hal.date.transferred | 2024-01-22T10:29:21Z | |
| hal.invited | oui | en_US |
| hal.proceedings | oui | en_US |
| hal.conference.end | 2023-10-24 | |
| hal.popular | non | en_US |
| hal.audience | Internationale | en_US |
| hal.export | true | |
| dc.rights.cc | Pas de Licence CC | en_US |
| bordeaux.COinS | ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.date=2023-10&rft.volume=34&rft.issue=supplement%202&rft.spage=S1033-S1033&rft.epage=S1033-S1033&rft.eissn=0923-7534&rft.issn=0923-7534&rft.au=COUSIN,%20S.&BELLERA,%20Carine&GUEGAN,%20Jean%20Philippe&VALENTIN,%20T.&VERRET,%20B.&rft.genre=unknown |
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