Phase 2 HERALD study of patritumab (P) with erlotinib (E) in advanced NSCLC subjects (SBJs)
J von Pawel, J Tseng, M Dediu, C Schumann, B Moritz, J Mendell, X Jin, W Feng, C Copigneaux, RA Beckman · Pneumologie · 2015 · Heft 02
Bibliografische Angaben
Zusammenfassung
Background: P is a fully human anti-HER3 antibody that inhibits HER3 binding with its ligand heregulin (HRG). Preclinically, P enhances anti-tumor activity with EGFR inhibitors, prevents HER3 reactivation after anti-EGFR treatment, and inhibits HRG- dependent activation. Phase Ib showed that P, with E (150mg/day PO), was tolerated at 18mg/kg IV q3w. Methods: This Ph2 randomized, placebo-controlled double-blind study assessed safety and efficacy of P+E vs. placebo (Pbo)+E in E-naïve sbjs with advanced NSCLC (2nd or later line). 215 sbjs were randomized to: 1) High Dose [HD]: P 18mg/kg IV q3w; 2) Low Dose [LD]: P:…
