Exploratory analysis of JFCM: Predictive value of rash, EGFR expression, and EGFR copy for necitumumab in squamous NSCLC

Abstract

Abstract Background JFCM, an open-label, multicenter, phase 1b/2 study (n = 181), demonstrated that addition of necitumumab (N) to gemcitabine and cisplatin (GC) resulted in significant improvement in overall survival (OS; hazard ratio [HR] = 0.66) in the first-line treatment of advanced squamous non-small cell lung cancer (NSCLC) patients in Japan. Previous studies have suggested that rash, EGFR expression, and EGFR copy number gain might be associated with the efficacy of EGFR-targeting drugs in the treatment of squamous NSCLC. Methods Our analysis assessed: development of acne-like rash in the first cycle; EGFR expression (evaluated by H-score of immunohistochemistry, H ≥ 200 vs H Results Of the 90 patients in the GC+N arm, 80 (88.9%) had first-cycle rash. Median OS was 14.52 vs 15.93 months (HR = 1.39) in patients experiencing first-cycle rash vs those without rash in the GC+N arm. For EGFR expression, the majority of patients had H Conclusion Our analysis did not identify first-cycle rash, EGFR expression, and EGFR copy number gain as predictive markers of survival in JFCM study. (Trial Registration Number: NCT01763788)