In patients with advanced BCC previously treated with a HHI,

LIBTAYO demonstrated disease control

Disease control rate (DCR)1*

Locally advanced BCC (n=84)

80%

Metastatic BCC (n=28)

68%

Durable DCR (DDCR)1†

Locally advanced BCC (n=84)

60%

Metastatic BCC (n=28)

46%

  • *DCR: proportion of patients with CR, PR, SD, or non-CR/non-PD at the first evaluable tumor assessment occurring no sooner than Day 56.1
    Durable DCR: proportion of patients with CR, PR, SD, or non-PR/non-PD for at least 182 days without PD.2
    Interim analysis.2
  • CR: 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: 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. Partial response 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
  • PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.2
  • SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.2
  • BCC=basal cell carcinoma; CR=complete response; HHI=hedgehog inhibitor; PD=progressive disease; PR=partial response; SD=stable disease