Idera Will Not Continue Tilsotolimod/Ipilimumab Combo Melanoma Trial Into OS Primary Endpoint

  • Idera Pharmaceuticals Inc IDRA has decided not to continue the ILLUMINATE-301 Phase 3 trial evaluating tilsotolimod in melanoma to its overall survival (OS) primary endpoint.
  • The trial assessed tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma.
  • In March, the company reported that the trial did not meet its primary endpoint of objective response rate (ORR).
    • ORR of 8.8% for the combination arm and 8.6% for ipilimumab alone.
    • Disease control rate of 34.5% for the combination and 27.2% for ipilimumab alone.
  • "Our conclusion is that the totality of the data, with all patients having completed the study treatment, does not support the likelihood that the combination of tilsotolimod with ipilimumab would achieve a statistically significant OS benefit over ipilimumab alone," stated Vincent Milano, CEO.
  • Full results from the study will be presented in a future publication.
  • The company announced that Elizabeth Tarka, the Company's Chief Medical Officer, will be leaving the Company on May 28.
  • Price Action: IDRA shares are down 1.89% at $1.04 during the premarket session on the last check Wednesday.
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