^
    Back
    Association details:
    Biomarker:No biomarker
    Cancer:Melanoma
    Drug:Opdivo (nivolumab) (PD1 inhibitor) +
    vidutolimod (CMP-001) (Immunomodulator, TLR9 agonist)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Businesswire
    Title:

    Checkmate Pharmaceuticals Granted FDA Fast Track Designation for CMP-001 Combined with PD-1 Blockade in the Treatment of Certain Types of Metastatic or Unresectable Melanoma

    Published date:
    07/27/2020
    Excerpt:
    ...the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its product candidate, CMP-001, a differentiated Toll-like receptor 9 (TLR9) agonist, in combination with a programmed death receptor 1 (PD-1) blocking antibody (nivolumab or pembrolizumab) for two development programs, including:...initial treatment of patients with unresectable Stage III or Stage IV melanoma to prolong the time to disease progression; and...treatment of patients with unresectable or metastatic melanoma refractory to prior anti-PD-1 blockade to improve the overall tumor response rate.