Association between progression free survival (PFS) rate (PFSR) and overall survival (OS) in LUME Meso, a study of nintedanib (N) vs. placebo (P) in combination with first line …

8568Background: We evaluated the relationship between PFSR and OS in the Phase II part of LUME-Meso, a double-blind, placebo-controlled study that showed improved PFS (primary endpoint; hazard ratio [HR] = 0.56; 95% confidence interval [CI]: 0.34–0.91; p = 0.017), for N vs P; for OS HR = 0.77; 95% CI 0.46–1.29. Methods: Pts with unresectable MPM (ECOG PS 0–1), stratified by histology (epithelioid/biphasic), were randomized 1:1 to receive ≤6 cycles PEM (500 mg/m2)/CIS (75 mg/m2) on Day 1 + N or P (200 mg bid on Days 2–21), followed by N or P monotherapy maintenance. PFSR was defined as the proportion of pts who did not meet criteria for progressive disease (PD) at the specified time point (a ‘landmark analysis’). PFSR was assessed at 6 (PFSR6) and 8 (PFSR8) months. The association with OS was then evaluated based on the progression status at the landmark. Pts who died prior to the …