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    Association details:
    Biomarker:MSI-H/dMMR
    Cancer:Solid Tumor
    Drug:Enweida (envafolimab) (PD-L1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    Alphamab Press Release
    Title:

    NMPA Grants Priority Review to the BLA for Envafolimab(KN035)

    Published date:
    01/19/2021
    Excerpt:
    Alphamab Oncology...announced that, the recombinant humanized PD-L1 single-domain antibody Envafolimab (Project Code: KN035) was granted priority review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The Envafolimab BLA is accepted for the treatment of microsatellite instability-high (MSI-H) advanced colorectal cancer, gastric cancer / mismatch repair deficient (dMMR) advanced solid tumors that have failed previous standard of care.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Envafolimab as Neoadjuvant Immuntherapy in Resectable Local Advanced dMMR/MSI-H Colorectal Cancer

    Excerpt:
    ...Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR)....
    Trial ID:
    NCT05371197
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    KN035 for dMMR/MSI-H Advanced Solid Tumors

    Excerpt:
    ...- Confirmed MMR deficient or MSI-H status....
    Trial ID:
    NCT03667170
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.

    Excerpt:
    ...Pathologically confirmed diagnosis of nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, WHO type II or III) without the need to detect MSI and dMMR status....
    Trial ID:
    NCT06059261
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer

    Excerpt:
    ......
    Trial ID:
    NCT05645094
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Hematol Oncol
    Title:

    Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors

    Published date:
    06/21/2021
    Excerpt:
    One hundred and three patients (65 with colorectal cancer, 18 with gastric cancer, and 20 with other solid tumors) were enrolled....Median progression-free survival was 11.1 months (95% CI 5.5 to not evaluable). Overall survival at 12 months was 74.6% (95% CI 64.7–82.1)....Envafolimab was effective and had acceptable safety in the treatment of previously treated advanced dMMR/MSI-H solid tumors.
    DOI:
    https://doi.org/10.1186/s13045-021-01095-1
    Trial ID:
    NCT03667170
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Ann Oncol
    Title:

    70MO Efficacy and safety of envafolimab (KN035) in advanced tumours with mismatch-repair deficiency

    Published date:
    11/01/2020
    Excerpt:
    ...study evaluated the efficacy and safety of KN035 in patients (pts) with advanced microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) cancer...103 pts with dMMR/MSI-H advanced cancer were enrolled...20 with other tumors...Confirmed ORR per BIRC was...40.0% in other tumors population...Envafolimab demonstrated robust anti-tumor activity...
    DOI:
    10.1016/j.annonc.2020.10.090
    Trial ID:
    NCT03667170