Treatment (tx) options for patients (pts) with squamous cell carcinoma (SCC) of the lung following chemotherapy are limited. In LUX-Lung 8 (LL8), in 795 pts with SCC of the lung, the irreversible ErbB family blocker, afatinib (A), significantly improved OS, PFS and DCR vs erlotinib (E), a reversible EGFR TKI. VeriStrat is a serum protein test that utilizes MALDI-TOF mass spectrometry to assign a ‘GOOD’ (VS-G) or ‘POOR’ (VS-P) classification and has shown prognostic and predictive utility for EGFR targeted agents in NSCLC.1 Here, the predictive ability of VeriStrat was tested in LL8; OS was the primary efficacy variable.
Pre-tx serum samples, blinded to clinical outcome, were classified as VS-G or VS-P based on predefined reference groups. Clinical outcomes were analyzed with respect to VeriStrat status in the overall population (all pts with both clinical and VeriStrat data) and in pre-defined subgroups.
675 pts were classified (VS-G: 412; VS-P: 263). In the VS-G group, median OS was 11.5 mo for A and 8.9 mo for E (HR [95% CI] 0.79 [0.63–0.98]; p = 0.03); median PFS was 3.3 mo for A and 2.0 mo for E (HR [95% CI] 0.73 [0.59–0.92]; p = 0.005). In the VS-P group, median OS was 4.7 mo for A and 4.8 mo for E (HR [95% CI] 0.90 [0.70–1.16]; p = n.s.); median PFS was 1.9 mo for both A and E (HR [95% CI] 0.96 [0.73–1.27]; p = n.s.). In pts treated with A, both OS (HR [95% CI] 0.40 [0.31–0.51]; p
VeriStrat has a strong independent stratification effect in pts with relapsed/refractory SCC of the lung treated with A. In these difficult to treat pts, A conferred significantly better OS and PFS than E in the VS-G group, with a median OS of 11.5 mo vs 8.9 mo. 1. Gregorc V, et al. Lancet Oncol 2014;15:713–21.
Clinical trial identification
Legal entity responsible for the study
G. Goss: Advisory board/board of directors: Astrazeneca, Pfizer, Boehringer Ingelheim, Lilly, Bristol Myers Squibb. E. Felip: Advisory board: Eli Lilly, Pfizer, Roche, BI Other: AZ, BMS, Novartis (Honoraria; lectures). A. Morabito: Other: Roche, AstraZeneca, Boehringer, Pfizer, Bayer (Honoraria). N. Dupuis: Stock ownership: Biodesix. V.K. Chand: Other: Current employer, EMD Serono; Previous employer BI. F. Solca: Other: Employed by BI. N. Krämer: Consultant to Boehringer Ingelheim Pharma GmBH & Co. KG, Biberach, Germany and receives compensation for these services. N. Gibson, E. Ehrnrooth: Employed by BI. J.C. Soria: Other: BI, Roche (honoraria). All other authors have declared no conflicts of interest.