Multinational phase 1b study of cofetuzumab pelidotin monotherapy for PTK7-expressing recurrent non-small cell lung cancer

Protein tyrosine kinase 7 (PTK7) overexpression in lung cancer is associated with tumor progression. Cofetuzumab pelidotin (Cofe-P) is an antibody-drug conjugate comprising an anti-PTK7 antibody conjugated to a microtubule inhibitor. A multinational phase 1b trial evaluated Cofe-P monotherapy among patients with recurrent non-small cell lung cancer (NSCLC) with PTK7 overexpression. All patients reported adverse events, most commonly alopecia (53%) and decreased neutrophil count (43%); 69% had grade ≥ 3 adverse events; there were no grade 5 treatment-related adverse events. Overall, the objective response rate was 18%; responses were seen in non-squamous EGFR wild type NSCLC (ORR 21%), non-squamous EGFR mutant NSCLC (ORR 15%), and squamous NSCLC (ORR 13%). Overall, median duration of response was 7.2 months, median progression-free survival was 5.5 months, and median overall survival was 12.6 months. The authors conclude that Cofe-P monotherapy demonstrated a manageable safety profile and preliminary efficacy for recurrent NSCLC with PTK7 expression.