Median duration of follow-up was 15.1 months for patients with laBCC1
In an exploratory subgroup analysis of patients with laBCC, ORR by reason for HHI discontinuation2:
This analysis may not have had enough power for hypothesis tests
ORR is determined by the proportion of patients with best overall response of CR or PR based on central-reviewed evaluation, as determined by RECIST version 1.1 for radiologic assessments, or by modified WHO Criteria for photographic assessments, or by the composite response criteria for patients assessed by both radiology and photography.2
CR is defined as disappearance of all target lesions for at least 4 weeks. Nontarget lesions also had to be a CR and there could be no new lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm (<1 cm). Only includes patients with complete healing of prior cutaneous involvement; patients with locally advanced BCC in the study required biopsy to confirm CR.2
PR is defined as a decrease of 30% or greater in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, per RECIST 1.1. PR of externally visible disease is defined as a decrease of 50% or greater in the sum of products of perpendicular longest diameters of target lesions, per WHO Criteria. Nontarget lesions could not have PD and there could be no new lesions. Responses had to be maintained for at least 4 weeks.2
BCC=basal cell carcinoma; HHI=hedgehog inhibitor; laBCC=locally advanced BCC; ORR=objective response rate; PD=progressive disease; PD-L1=programmed death ligand 1; RECIST=Response Evaluation Criteria in Solid Tumors; TMB=tumor mutational burden; WHO=World Health Organization.
No PD-L1 or TMB testing is required before starting LIBTAYO for locally advanced BCC.1,2