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Table 2 Incidence of DR at Each Landmark Time Assessment in OPTiM Patients Treated with Talimogene Laherparepvec and GM-CSFa

From: Durable response rate as an endpoint in cancer immunotherapy: insights from oncolytic virus clinical trials

Landmark Time, Months Patients Alive, n DR Achieved, n HR for OS in Patients with DR Versus Those Without, HR (95% CI) Adjusted HR for OS in Patients with DR Versus Those Without HR (95% CI)b
9 335 22 0.07 (0.01–0.48) 0.07 (0.01–0.54)
12 304 36 0.05 (0.01–0.33) 0.05 (0.01–0.35)
18 236 50 0.11 (0.03–0.44) 0.11 (0.03–0.47)
  1. DR durable response, GM-CSF granulocyte macrophage-colony stimulating factor, HR hazard ratio, ITT intent-to-treat, OS overall survival
  2. aAnalysis was performed in ITT population of OPTiM
  3. bAdjusted for disease stage (stage IIIB, IIIC, IVM1a versus stage IVM1b, IVM1c) and line of therapy (first-line versus second-line)