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    Association details:
    Biomarker:MSI-H/dMMR
    Cancer:Urothelial Cancer
    Drug:Opdivo (nivolumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Colorectal Cancer)
    New
    Title:

    ONO Receives Approval of Opdivo® (Nivolumab) for Additional Indications of Unresectable Advanced or Recurrent Esophageal Cancer, and MSI-High Unresectable Advanced or Recurrent Colorectal Cancer in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval

    Excerpt:
    Ono Pharmaceutical Co., Ltd....and Bristol-Myers Squibb...announced today that ONO received approval of Opdivo® (generic name: nivolumab) Intravenous Infusion (“Opdivo”), a human anti-human programmed cell death-1 (PD-1) monoclonal antibody in Japan for the following two additional indications, for a partial change in approved items of the manufacturing and marketing approval:...Microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed following chemotherapy...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of MT-8421 as Monotherapy and in Combination With Nivolumab in Patients With Selected Advanced Solid Cancer Types

    Excerpt:
    ...- Histologically confirmed, unresectable, locally advanced, or metastatic melanoma, HCC, NSCLC, RCC, MSI-H/dMMR malignancies, urothelial carcinoma, esophageal squamous cell carcinoma, mesothelioma, SCCHN, or cervical carcinoma...
    Trial ID:
    NCT06034860
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO-GU 2021
    Title:

    Efficacy of immune checkpoint blockade in patients with advanced upper tract urothelial cancer and mismatch repair deficiency or microsatellite instability (MSI).

    Published date:
    02/08/2021
    Excerpt:
    Ten pts were identified with locally advanced unresectable (N = 3) or metastatic (N = 7) dMMR/MSI UTUC who received therapy with IC blockade (pembrolizumab = 7, nivolumab = 2, atezolizumab = 1). Median age was 65.5 (range = 46 – 90). Six pts were male. Seven pts had germline dMMR. MSI was detected by PCR in three pts and dMMR by IHC in seven pts...all pts were alive, and none experienced disease progression. PFS and OS at 15.5 months were 100%. The observed ORR was 90% (CI, 55.5%, 99.8%)...
    DOI:
    10.1200/JCO.2021.39.6_suppl.487