About ADCT-402 (loncastuximab tesirine)

ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD)-dimer toxin. Once bound to a CD19-expressing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is an ideal target for an ADC approach, as it is highly expressed in a range of B-cell hematological tumors, including certain types of lymphoma and leukemia, while its expression in healthy tissue is restricted.

The U.S. Food and Drug Administration has granted orphan drug designation to ADCT-402 for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL).

Enrollment in a pivotal Phase II clinical trial of ADCT-402 in patients with relapsed or refractory (R/R) DLBCL ( Identifier NCT03589469) is complete. ADCT-402 is being evaluated in a Phase I trial in combination with ibrutinib in patients with R/R DLBCL or MCL (NCT03684694) and a Phase I trial in combination with durvalumab in patients with R/R DLBCL, MCL or follicular lymphoma (NCT03685344).

Interim First-in-Human Data

ADCT-402 continues to demonstrate an acceptable safety profile and strong single-agent anti-tumor activity in patients with relapsed or refractory diffuse large B-cell lymphoma. Updated data from the ongoing 183-patient Phase I clinical trial of ADCT-402 were presented at the 60th American Society of Hematology (ASH) Annual Meeting.

ADCT-402 / ASH 2018