Phase I/II study of tecemotide immunotherapy for Japanese patients with unresectable stage III NSCLC

摘要

We report results from a phase I/II study of tecemotide in Japanese pts with stage III NSCLC. Eligible pts had unresectable stage III NSCLC with no PD after CRT（platinum-based chemo and ≥50 Gy radiotherapy）. The phase II treatment schedule and dose were confirmed in phase I. In phase II, 172 pts were randomized（2：1, double-blind）from Feb 2010 to Feb 2012；114 received tecemotide（930ug lipopeptide）and 58 received placebo（PBO）, SC weekly x8 then q6 wks until PD or withdrawal. Cyclophosphamide 300mg/m2 x1 or saline was given 3 days before first tecemotide or PBO dose, respectively. Baseline characteristics were well balanced between arms. Most pts（94%）received concurrent CRT. The primary endpoint of median OS was 32.4 vs 32.2 months（m）with tecemotide vs PBO（HR 0.95, 95% CI 0.61-1.48）. Secondary endpoints were PFS：11.6 vs 8.0 m（HR 0.95, 95% CI 0.66-1.37）；TTP：11.3 vs 7.0 m（HR 0.94, 95% CI 0.65-1.35）；TTF：8.0 vs 6.2 m（HR 1.07, 95% CI 0.75-1.54）. No OS improvement was observed with tecemotide vs PBO in any of the subgroups examined in a predefined analysis. Tecemotide was associated with more G3/4 AEs vs PBO, but no new safety concerns were identified. No treatment-related G3/4 injection site reactions were detected. In conclusion, in this study, whose design was comparable to the global phase III START trial, tecemotide maintenance therapy did not improve OS compared with PBO in Japanese patients with stage III NSCLC, and no improvement in secondary endpoints was observed. Tecemotide was well tolerated, with no clinically relevant increase in AEs.