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8566Background: In the double-blind, placebo-controlled phase II/III LUME-Meso trial, N was combined with up to 6 cycles of PEM/CIS, followed by N monotherapy until progression or toxicity. The primary analysis… Click to show full abstract
8566Background: In the double-blind, placebo-controlled phase II/III LUME-Meso trial, N was combined with up to 6 cycles of PEM/CIS, followed by N monotherapy until progression or toxicity. The primary analysis of phase II showed improved progression-free survival (primary endpoint) with N vs P (hazard ratio (HR) = 0.56; 95% confidence interval (CI): 0.34–0.91; p = 0.017); for overall survival HR = 0.77; 95% CI 0.46–1.29. We evaluated outcomes in the combination and monotherapy phases to understand better the overall study results. Methods: Pts with unresectable MPM (ECOG PS 0–1), stratified by histology, were randomized 1:1 to receive ≤6 cycles PEM (500 mg/m2)/CIS (75 mg/m2) Day 1 + N or P; 200 mg bid, Days 2–21), followed by N or P monotherapy maintenance. TE was analyzed for PEM/CIS, N and P. TB, measured using sum of diameter by modified RECIST 1.0, was analyzed over time, using a mixed-effects model in pts with at least two imaging datapoints. Results: 87 pts were randomized: 85 pts (N: 44, P: 41) we...