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    Association details:
    Biomarker:PD-L1 expression
    Cancer:Rectal Cancer
    Drug:Opdivo (nivolumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Non Small Cell Lung Cancer)
    New
    Title:

    Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression ≥1%

    Excerpt:
    Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%....The EC’s decision is based on results from the Phase 3 CheckMate -816 trial, in which three cycles of Opdivo with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) compared to chemotherapy alone when administered before surgery.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Clin Cancer Res
    Title:

    Preoperative Chemoradiotherapy Plus Nivolumab Before Surgery in Microsatellite Stable and Microsatellite Instability-High Locally Advanced Rectal Cancer Patients

    Published date:
    01/21/2022
    Excerpt:
    In phase I, we investigated the feasibility of sequentially-combined CRT, 5 cycles of nivolumab, and radical surgery. In phase II, patients with microsatellite stable (MSS) and microsatellite instability-high (MSI-H) LARC were evaluated. A pathological complete response (pCR) was centrally confirmed in 30% (11/37; 90% CI, 18 %-44%) and 60% (3/5) of the MSS and exploratory MSI-H cohorts, respectively. PD-L1 expression and an elevated CD8/eTreg ratio were positive predictors in patients with MSS LARC.
    Secondary therapy:
    Chemotherapy
    DOI:
    10.1158/1078-0432.CCR-21-3213
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2020
    Title:

    Translational research of voltage-A1: Efficacy predictors of preoperative chemoradiotherapy and subsequent nivolumab monotherapy in patients with microsatellite-stable locally advanced rectal cancer.

    Published date:
    05/13/2020
    Excerpt:
    ...PD-L1-positive...and higher tumor mutation burden are good predictors of the efficacy of the sequential combination of CRT and nivolumab.
    DOI:
    10.1200/JCO.2020.38.15_suppl.4073