^
    Back
    Association details:
    Biomarker:MSI-H/dMMR
    Cancer:Gastric Cancer
    Drug:Imfinzi (durvalumab) (PD-L1 inhibitor) +
    Imjudo (tremelimumab) (CTLA4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Published date:
    08/29/2023
    Excerpt:
    Gastric Cancer: Useful in Certain Circumstances…MSI-H/dMMR tumors…Tremelimumab and durvalumab for neoadjuvant therapy only…
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    GC 2nd Line Durvalumab(MEDI4736)/Tremelimumab Plus Paclitaxel Study

    Excerpt:
    ...(for the phase II section) Have one of the following targeted sequencing results 1) CD274 amplification 2) positive for mutations causing a hypermutation (PMS1, PMS2, MLH1, MLH3, MSH2, MSH3, MSH6, POLD1, POLD2, or POLE) 3) microsatellite instability (MSI high) 4) somatic exonic mutation rate-high 5) EBV positive 9....
    Trial ID:
    NCT03751761
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Study on the combination of two immunotherapeutic agents as pre-surgical therapy or definitive treatment in patients with resectable gastric or gastroesophageal junction cancer with microsatellite instability. Studio con la combinazione di due farmaci immunoterapici come terapia prima della chirurgia o come terapia definitiva in pazienti con tumore gastrico o della giunzione gastro-esofagea operabile con instabilità dei microsatelliti.

    Excerpt:
    ...MSI-high and dMMR status confirmed by IHC and multiplex PCR, and EBV-negative status by ISH, as determined centrally at the Co-ordinating Centre. ...
    Trial ID:
    2020-003440-92
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO-GI 2023
    Title:

    INFINITY: A multicentre, single-arm, multi-cohort, phase II trial of tremelimumab and durvalumab as neoadjuvant treatment of patients with microsatellite instability-high (MSI) resectable gastric or gastroesophageal junction adenocarcinoma (GAC/GEJAC).

    Published date:
    01/17/2023
    Excerpt:
    Overall, 18 pts with MSI/dMMR resectable cT2-4 any N GAC/GEJAC were recruited in Cohort 1….Among 15 evaluable patients, 1 had disease progression and 14 underwent resection. pCR rate was 60% (9/15) and major-complete pathological response (<10% viable cells) was 80%....Pre-operative T300/D for 3 months was safe and provided promising proof of efficacy in MSI, dMMR GAC/GEJAC pts.
    DOI:
    10.1200/JCO.2023.41.3_suppl.358
    Trial ID:
    INFINITY
    Test:
    PD-L1 IHC 22C3 pharmDx
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO-GI 2023
    Title:

    Phase II study of the combination of durvalumab, tremelimumab, and paclitaxel as second-line chemotherapy in biomarker-selected patients with metastatic gastric cancer.

    Published date:
    01/17/2023
    Excerpt:
    Compared to mGC with other genetic alterations (n=25), mGC with TMB >20/Mb or MSI-high mGC (n=23) tended to have a higher ORR (56.5% vs 48%), and a prolonged PFS (median 7.2 vs 4.5 months; 44.0 vs 20.8% at 1 year)….The combination chemotherapy of durvalumab, tremelimumab, and paclitaxel showed encouraging efficacy, especially in mGC with TMB >20/Mb or MSI-high mGC, as a second-line chemotherapy with manageable toxicities in biomarker-selected mGC.
    Secondary therapy:
    paclitaxel
    DOI:
    10.1200/JCO.2023.41.3_suppl.401
    Trial ID:
    NCT03751761