CD19-positive human Burkitt lymphoma (Ramos, Daudi) and DLBCL (WSU-DLCL2) xenografts in immunodeficient mice
“The in vivo activity of ADCT‐402 was evaluated in immunodeficient mice subcutaneously (SC) xenografted with the CD19 positive human Ramos or Daudi Burkitt’s lymphoma cell lines or with the CD19 positive human DLBCL cell line, WSU‐DLCL2 (Study No. ADCT‐402_R_007_R).”
✓ VerifiedFDA multi-discipline review, p. 43Source ↗
Why that model
Antibody selective for human CD19; not cross-reactive with CD19 of any nonclinical species
“The monoclonal antibody (mAb) component of loncastuximab tesirine, RB4v1.2, is selective for human CD19 and not cross‐reactive with CD19 from any nonclinical species.”
✓ VerifiedFDA multi-discipline review, p. 37Source ↗
Reviewer's view of the efficacy data
EMA: studies in lymphoma/leukaemia patient-derived cell lines supported clinical testing; cancer cell lines accepted for ADCs
“The nonclinical studies conducted with ADCT-402 using a panel of cell lines derived from lymphoma and leukaemia patients have supported the clinical testing of loncastuximab tesirine in patients. Findings from these nonclinical studies support the use of cancer cell lines for nonclinical studies with ADCs.”